malaria rapid diagnostic test performance: results of...
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Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 5 (2013)
Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 5 (2013)
I I I
WHO Library Cataloguing-in-Publication Data:Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 5 (2013).1.Diagnostic Techniques and Procedures. 2.Malaria - diagnosis. 3.Diagnostic Tests, Routine - methods. I.World Health Organization.
ISBN 978 92 4 150755 4 (NLM classification: WC 750)
© World Health Organization 2014
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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.
Layout: Bruno Duret - Editor: Elisabeth Heseltine
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Reference to any company or product in this report, particularly those listed in any of the figures and tables, does not constitute an endorsement, certification, or warranty of fitness by WHO of such company or product for any purpose, and does not imply any preference over companies or products of a similar nature that are not mentioned.
WHO does not furthermore warrant that: (1) the lists and figures are complete and/or error free; and/or that (2) any products included in the figures and tables are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws. Inclusion of any products in this report, particularly in any of the figures and tables listed on pages V-VII, does not furthermore imply any approval by WHO of these products (which is the sole prerogative of national authorities).
The WHO Programme of Prequalification of Diagnostics and Medical Devices uses the results of the WHO Malaria RDT Product Testing Programme as the laboratory evaluation component of the prequalification process for malaria RDTs. Although not currently a requirement for WHO procurement, manufacturers are encouraged to apply for WHO prequalification. A regularly updated list of WHO-prequalified diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
WHO recommendations for procurement of malaria RDTs are currently based on the attainment of a set of minimum performance criteria in the WHO Malaria RDT Product Testing Programme. These recommendations were established by the WHO Malaria Policy Advisory Committee in 2012 , are outlined in this report and presented in full in a WHO information note (available at http://www.who.int/malaria/publications/atoz/rdt_selection_criteria_en.pdf?ua=1).Products that do not meet the full set of minimum performance criteria are not eligible for procurement by WHO.
The lists of RDTs included in this report are not exhaustive lists of malaria RDTs. These lists reflect those products which have been submitted for evaluation in Rounds 2-5 of the WHO Malaria RDT Product Testing Programme, and indicate to what extent these products, as manufactured by the listed companies, were -at the time of their evaluation- found to meet the above mentioned set of minimum performance criteria. The evaluation results indicated in the figures and tables apply only to the specific product as listed with its unique product code / catalogue number and as manufactured by the listed company.
The improper storage, transport and handling of malaria RDTs may affect their level of performance.
The fact that certain products are not included in the lists and figures in this report indicates that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme, or that their evaluation has not yet been completed and published in [a new edition of this report]. It does not however indicate anything in respect of such products’ performance. The lists and figures are updated regularly, and malaria RDTs are added to the lists and figures as and when (following the voluntary participation in the WHO Malaria RDT Product Testing Programme) their evaluation against the above mentioned set of minimum performance criteria has been completed.
Although the malaria RDTs listed in the tables and figures are regularly re-evaluated, and updated evaluation results are published by WHO, WHO cannot represent that products included in the lists and figures will continue to meet the performance criteria in the same manner as indicated. WHO recommends therefore that before procurement of a malaria RDT, each lot of that product undergoes lot testing at one of the two following lot-testing laboratories: Institut Pasteur du Cambodge (IPC), Cambodia or Research Institute for Tropical Medicine (RITM), The Philippines.
WHO disclaims any and all liability and responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of or in connection with the procurement, distribution and use of any product included in this report and the figures and tables listed on pages V-VII.
This report may not be used by manufacturers and suppliers for commercial or promotional purposes.
I I IMalaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013) I I I
Contents acknoWledgeMents Viii
abbreViations iX1. sUMMarY of perforMance of rapid diagnostic tests for Malaria: WHo prodUct testing roUnds 1–5 11.1. introduction 11.2. the WHo product testing programme 11.3. panel detection score and other results
of the evaluation 21.4. summary of outcomes 41.5. How can product testing results inform rdt
procurement and use? 51.6. product testing and WHo programme for
prequalification of diagnostics and medical devices 5
2. WHo Malaria rdt prodUct testing: roUnd 5: eXecUtiVe sUMMarY 202.1. introduction 202.2. the WHo product testing programme 202.3. results of the evaluation 212.4. Use of the results 22
3. backgroUnd 224. objectiVe 245. Materials and MetHods 245.1. test selection 245.2. the product testing protocol 265.3. evaluation panels 275.4. rdt registration 295.5. specimen panel registration 295.6. test phases 295.7. performing rapid tests 295.8. interpreting the results 30
6. data ManageMent 317. QUalitY assUrance 318. etHical considerations 329. data analYsis 329.1. Measures of parasite detection: panel detection
score and positivity rates 329.2. false-positive results 32
9.2.1 incorrect species identification 329.2.2 false-positive results for Plasmodium-negative samples 33
9.3. band intensity 339.4. lot agreement 339.5. invalid tests 339.6. Heat (thermal) stability 33
VIV Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
10. relation betWeen parasite densitY and antigen concentration 34
11. laboratorY VersUs field-based Malaria rdt eValUations 34
12. resUlts 3512.1. summary 3512.2. phase 1: P. falciparum culture panel 40
12.3.1 P. falciparum detection 4112.3.2 P. vivax detection 4212.3.3 combined detection of P. falciparum and P. vivax 4212.3.4 P. falciparum and P. vivax positivity rate 4312.3.5 band intensity 4312.3.6 false-positive rates 45
12.4. performance of products under the compulsory resubmission requirement 48
13. Heat stabilitY 5014. ease-of-Use description and rdt
anoMalies 5715. discUssion of keY findings 6015.1. panel detection score and its relation to sensitivity 6015.2. false-positive rate and specificity 6115.3. reactivity of combination Hrp2 and pan-pldH
test lines against P. falciparum samples 6115.4. Heat (thermal) stability 6215.5. ease-of-use description and rdt anomalies in
production lots 6215.6. inter-lot variation 6315.7. target antigens and species 63
16. Using resUlts to ensUre HigH-QUalitY diagnosis in tHe field 6416.1. beyond procurement 6416.2. lot testing 64
17. conclUsions 6518. references 65anneXes 67annex s1: characteristics of evaluation panels used
in rounds 1–5 of WHo malaria rdt product testing, 2008–2013 68
annex s2: Malaria rdt field assessment and anomalies 71annex s3: selection of an appropriate rdt 74annex 1: characteristics of rdts evaluated in round 5 75annex 2: Malaria rdts: guide to interpretation of results 77annex 3: phase-1 results 92annex 4: phase-2 results 96annex 5: introducing rdt-based malaria diagnosis
into national programmes 125
VIV Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
figures
Figure S1: Malaria RDT performance in phase 2 of rounds 2–5 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Figure S2: Malaria RDT performance in phase 2 of rounds 2–5 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Figure S3: Panel detection score of malaria combination and pan-only RDTs meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 2–5 against wild-type (clinical) samples containing P. falciparum and P. vivax at low parasite density (200 parasites/μL)
Figure 1: Mode of action of antigen-detecting malaria RDTs
Figure 2: Network of specimen collection, characterization and testing sites
Figure 3: Overview of malaria RDT product testing
Figure 4a: Origin of phase-2 P. falciparum wild-type (clinical) samples
Figure 4b: Origin of phase-2 P. vivax wild-type (clinical) samples
Figure 5: Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 200 parasites/μL
Figure 6: Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 2000 parasites/μL
Figure 7: Classification of incorrect species identification with combination malaria RDTs
Figure 8: Explanation of lot agreement calculation
Figure 9: Phase-1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL) according to target antigen type (HRP2 or pLDH)
Figure 10: Phase-2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL) according to target antigen type (HRP2 or pLDH)
Figure 11: Phase-2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL) according to target antigen type (aldolase, pLDH)
Figure 12: Phase-2 P. falciparum panel detection score and positivity rate at 200 parasites/μL
Figure 13: Phase-2 P. vivax panel detection score and positivity rate at 200 parasites/μL
Figure 14: Phase-2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samples
Figure 15: Phase-2 Plasmodium spp. (pan or P. vivax/Pvom test line) false-positive rate against clean-negative samples
Figure 16: Phase-2 P. falciparum false-positive rate versus P. falciparum panel detection score at low parasite density (200 parasites/μL)
Figure 17: Phase-2 P. vivax false-positive rate versus P. vivax panel detection score at low parasite density (200 parasites/μL)
Figure 18: Phase-2 P. falciparum panel detection score at low parasite density (200 parasites/μL) during initial and subsequent testing of compulsorily and voluntarily resubmitted malaria RDTs
Figure 19: Phase-2 P. vivax panel detection score at low parasite density (200 parasites/μL) during initial and subsequent testing of compulsorily and voluntarily resubmitted malaria RDTs
Figure 20: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure 21: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure 22: Heat stability of P. falciparum-specific test line in combination tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure 23: Heat stability of P. falciparum-specific test line in combination tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure 24: Heat stability of pan line of pan-specific tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
VIIVI Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 25: Heat stability of pan line of pan-specific tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure 26: Heat stability of pan line of combination tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure 27: Heat stability of pan line of combination tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
Figure AS1.1: Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.2: Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.3: Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.4: Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.5: Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS2.1: Malaria RDT anomalies encountered in production lots
Figure AS3.1: Selecting an appropriate RDT
Figure A5.1: Example of malaria RDT implementation steps and timeline
Figure A5.2: Components of the budget for a malaria diagnosis programme
tables
Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1–5
Table S2 Malaria RDT phase-2 performance in rounds 2–5 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Table S3: Malaria RDT rounds 2–5 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline and after 60 days’ incubation at 35 °C and 45 °C
Table 1a: Manufacturers and products accepted into round 5 of WHO malaria RDT product testing programme
Table 1b: Products due for compulsory resubmission in round 5
Table 2: Characteristics of Plasmodium spp.-negative samples
Table 3: Malaria antigen concentrations (ng/mL) in round 5 wild-type, low-density (200 parasites/μL) samples
Table 4: Summary of phase-1 performance of 42 malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000) parasite density (parasites/µL)
Table 5: Summary of phase-2 performance of 42 malaria RDTs against wild-type (clinical) P. falciparum and P. vivax samples at low (200) and high (2000) parasite density (parasites/µL) and Plasmodium spp.-negative samples
Table 6: Heat stability testing results for 42 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at 35 °C and 45 °C
Table 7: Ease-of-use description of 42 malaria RDTs evaluated in round 5 of WHO malaria RDT product testing
Table 8: Observations on RDT production lots that could affect test interpretation
VIIVI Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in wild-type product testing phase 2 (wild-type) panels.
Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Table A3.1: Lot variation in positive results against P. falciparum culture samples at low (200) and high (2000) parasite density (parasites/µL)
Table A3.2: Distribution of test band intensity scores (0–4) against phase-1 P. falciparum cultured parasites at low (200) and high (2000) parasite density (parasites/µL)
Table A4.1: Lot variation in positive results against phase-2 wild-type P. falciparum and P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)
Table A4.2: Distribution of test band intensity (0–4) scores against phase-2 wild-type P. falciparum samples at low (200) and high (2000) parasite density (parasites/µL)
Table A4.3: Distribution of pan/Pv test band intensity (0–4) scores for phase-2 wild-type P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)
Table A4.4: Panel detection score of phase-2 wild-type P. falciparum at low (200) and high (2000) parasite density (parasites/µL) by continent
Table A4.5: Phase-2 P. falciparum test line false-positive rates for wild-type P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)
Table A4.6: Phase-2 pan (or P. vivax/Pvom) test line false-positive rate for non-P. falciparum infection on phase-2 wild-type P. falciparum samples at low (200) and high (2000) parasite density (parasites/µL)
Table A4.7: Phase-2 false-positive rate for P. falciparum test line results on all malaria-negative samples
Table A4.8: Phase-2 false-positive rate for P. falciparum in samples containing non-malarial infectious pathogens
Table A4.9: Phase-2 false-positive rate for P. falciparum in samples containing potentially cross-reacting blood immu-nological factors
Table A4.10: Phase-2 false-positive rate of pan, P. vivax or Pvom test line results in all malaria-negative samples
Table A4.11: Heat stability testing results for P. falciparum (or pan) test line on a P. falciparum sample at low parasite density (200 parasites/μL). Positivity rate after 60 days at baseline (room temperature) and after incubation at 35 °C and 45 °C
Table A4.11a: Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at low parasite density (200 parasites/μL). Positivity rate after 60 days at baseline (room temperature) and after incubation at 35 °C and 45 °C
Table A4.12: Heat stability testing results for P. falciparum (or pan) test line on a P. falciparum sample at high parasite density (2000 parasites/μL). Positivity rate after 60 days at baseline (room temperature) and after incubation at 35 °C and 45 °C
Table A4.12a: Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at high parasite density (2000 parasites/μL). Positivity rate after 60 days at baseline (room temperature) and after incubation at 35 °C and 45 °C
Table A4.13: Heat stability testing results for P. falciparum (or pan) test line on parasite-negative samples. Positivity rate after 60 days at baseline (room temperature) and after incubation at 35 °C and 45 °C
Table A4.13a: Heat stability testing results for pan test line of combination RDTs on parasite-negative samples. Positivity rate after 60 days at baseline (room temperature) and after incubation at 35 °C and 45 °C
IXVII I Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
acknoWledgeMents
The evaluation reported here was a joint project of the WHO Global Malaria Programme, the Foundation for Innovative New Diagnostics (FIND) and the United States Centers for Disease Control and Prevention (CDC) within the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND through a grant from UNITAID. The project would not have been possible without the cooperation and support of the specimen collection sites and specimen characterization laboratories mentioned, and the authors acknowledge the technical advice from many malaria diagnostic manufacturers and developers. This report of round 5 of WHO malaria RDT product testing was compiled by Jane Cunningham (WHO, Global Malaria Programme, Switzerland) and Michelle Gatton (Queensland University of Technology, University of Queensland, Australia).
The malaria RDT evaluation programme of WHO and FIND are grateful to all those who contributed to the evaluation and to the preparation of this report:
Salim Abdullah Ifakara Health Research and Development Centre, United Republic of Tanzania
Yong Ah United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
Frederic Ariey Institut Pasteur, Cambodia
John Barnwell United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
David Bell Foundation for Innovative New Diagnostics, Switzerland
Andrea Bosman WHO, Global Malaria Programme, Switzerland
Qin Cheng Army Malaria Institute, Australia
Peter Chiodini Hospital for Tropical Diseases, United Kingdom
Jane Cunningham WHO, Global Malaria Programme, Switzerland
Chona Daga Research Institute of Tropical Medicine, Philippines
Djibrine Djalle Institut Pasteur of Bangui, Central African Republic
Babacar Faye Université Cheikh Anta Diop, Senegal
Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru
Michelle Gatton Queensland University of Technology, Australia
Jeffrey Glenn United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
Iveth Gonzalez Foundation for Innovative New Diagnostics, Switzerland
Sandra Incardona Foundation for Innovative New Diagnostics, Switzerland
Cara Kosack Médecins sans Frontières, Netherlands
Myat Phone Kyaw Department of Medical Research, Myanmar
Brigette Lawhorn United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
Jennifer Luchavez Research Institute of Tropical Medicine, Philippines
Christian Luna Research Institute of Tropical Medicine, Philippines
Lorraine Mationg Research Institute of Tropical Medicine, Philippines
James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia
Didier Menard Institut Pasteur, Madagascar; Institut Pasteur, Cambodia
Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas, Colombia
IXVII I Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Sina Nhem Institut Pasteur, National Malaria Centre, Cambodia
Bernhards Ogutu Kenya Medical Research Institute, Kenya
Pamela Onyor Kenya Medical Research Institute, Kenya
Wellington Oyibo University of Lagos, Nigeria
Mark Perkins Foundation for Innovative New Diagnostics, Switzerland
Roxanne Rees-Channer Consultant, Foundation for Innovative New Diagnostics, Hospital for Tropical Diseases, United Kingdom
Muth Sinuon National Malaria Centre, Cambodia
Jobel Sornillo Research Institute of Tropical Medicine, Philippines
Man Somnang Institut Pasteur, National Malaria Centre, Cambodia
Julie Vercruysse Foundation for Innovative New Diagnostics, Switzerland
Scott Wilson United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States
1X Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
abbreViations
CDC United States Centers for Disease Control and Prevention
ELISA enzyme-linked immunosorbent assay
FIND Foundation for Innovative New Diagnostics
HRP2 histidine-rich protein 2
ISO International Organization for Standardization
PCR polymerase chain reaction
PDS panel detection score
pLDH Plasmodium lactate dehydrogenase
Pf Plasmodium falciparum
Pv Plasmodium vivax
Pvom Plasmodium vivax, ovale, malariae
RDT rapid diagnostic test (for the purposes of this report, immunochromatographic lateral flow devices for the detection of malaria parasite antigens)
TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, the World Bank and WHO
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1X Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
1. sUMMarY of perforMance of rapid diagnostic tests for Malaria: WHo prodUct testing roUnds 1–5
1.1. introductionWHO estimates that half the world’s population is at risk of malaria. In 2012, there were an estimated 207 million cases (with an uncertainty range of 135 million to 287 million) and an estimated 627 000 deaths (with an uncertainty range of 473 000 to 789 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under 5 years. Malaria remains endemic in 104 countries, and, while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of antimalarial drugs and poor disease monitoring (1).
WHO recommends that malaria case management be based on parasite diagnosis in all cases (2). The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained. The number of RDTs available and the scale of their use have increased rapidly over the past few years; however, limita-tions of field trials and the heterogeneous nature of malaria transmission have limited the availability of the good-quality data on performance that national malaria programmes require to make informed decisions on procurement and implementation, and it is difficult to extrapolate the results of field trials to different populations and times. Therefore, in 2006, the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched a programme to systematically evaluate and compare the performance of commercially available malaria RDTs. The results of WHO’s malaria RDT product testing have been published annually since 2009 and form the basis of the procurement criteria of WHO, other United Nations agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, national governments and nongovernmental organizations. The data have guided procurement decisions, which, in turn, have shifted markets towards better-performing tests1 and are driving overall improvements in the quality of manufacturing.
This summary presents an overview of the results of rounds 1–5 of malaria RDT product testing and key concepts for understanding and using the results. It is published in conjunction with the release of the full report on round 5. The results of all rounds of testing should be considered as a single data set. The separate, full reports of each round (3–6) should be consulted for further details of methods, product performance and interpretation of the results.
1.2. the WHo product testing programmeThe RDT evaluations summarized here were performed in collaboration by WHO, TDR, FIND, the United States Centers for Disease Control and Prevention (CDC) and other partners.1 All companies that manufacture according to the ISO 13485:2003 quality system standard were invited to submit one to three products for evaluation in the programme. In each round of testing, products are evaluated against geographically diverse, cryopreserved Plasmodium falci-parum and P. vivax clinical samples diluted to 200 and 2000 parasites/µL and with consistently comparable concen-tration ranges of histidine-rich protein II (HRP2), Plasmodium lactate dehydrogenase (pLDH) and aldolase determined by quantitative enzyme-linked immunosorbent assay (ELISA) (Annex S1). In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured P. falciparum parasites, while 29, 50, 48 and 42 products from 13, 23, 27 and 34 manufacturers were evaluated in rounds 2, 3, 4 and 5, respectively. Of these 210 products, 206 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive assessment of ease of use was made. Many manufacturers have decided voluntarily to submit products to one or more rounds of testing, and, in round 5, a require-ment was instituted to resubmit products for re-evaluation within 5 years of original testing (Table S1). Of the 206 fully evaluated products, 32 have been evaluated twice, 11 have been evaluated three times and two evaluated four times in rounds 1–5. Of the 147 unique products tested in the programme, 36 detect P. falciparum alone, 101 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific for P. vivax or P. vivax, ovale and malariae), 9 detect P. falciparum and non-P. falci-parum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. When the same products (7) were resubmitted in subsequent rounds of testing, the second set of results replaced those from the earlier round. Thus, the performance of some tests in the results below differs from that reported in rounds 1–4.
Of the 22 products due for compulsory retesting in round 5, 10 were submitted (Table S1). Round 1 products that were not
1 See full reports of rounds 1–5 (3–6) for lists of collaborating partners.
32 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
resubmitted have been removed from the figures and tables in this summary performance document.
The aim of the evaluation is to provide comparative data on the performance of the submitted production lots of each product. These data will be used to guide procure-ment decisions by WHO, other United Nations agencies and national governments and constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs (8). Product testing is part of a continuing programme of work to improve the quality of RDTs in use and to ensure reliable malaria diagnosis in areas where malaria is prevalent. A sixth round of product testing will begin in June 2014.
1.3. panel detection score and other results of the evaluationThe results (summarized in Figs S1–S3 and Tables S2 and S3) provide comparative data on two lots of products against a panel of parasite samples diluted to a low parasite density (200 parasites/µL) and a higher parasite density (2000 or 5000 parasites/µL). The former is well below the mean parasite density found in many populations with endemic malaria and is considered close to the threshold that must be detected in order reliably to identify clinical malaria in many settings (9). For the purposes of this report, the main measure of performance is the panel detection score (PDS);1 for each RDT evaluated, the PDS is measured separately at the
1 Termed “detection rate” in the full report of round 1, published in 2009.
Box 1: Example calculation of panel detection score and positivity rate for product A against a sample density of 200 parasites/µL
The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.
Product A
c dReading
1Reading
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1 + - + + Sample NOT detected
2 + - - + Sample NOT detected
3 + + + + Sample detected
In this example, only one of three samples was positive all four times it was tested; the PDS is therefore 1/3 = 33%.
The positivity rate is calculated as the percentage of all tests of a particular product that returned a positive test result at the manufacturers’ recommended minimum reading time when tested against a P. falciparum or P. vivax sample.
In the above example, the positivity rate is: 9/12 = 75%.
The positivity rate is always greater than the PDS, except when the PDS and the positivity rate are both 100%.
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32 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
lower and the higher parasite density. The summary figures also show the false-positive rates against blood samples containing no malaria parasites or known markers of other diseases and the rate of invalid results.
The PDS is the percentage of malaria samples in the panel that give a positive result in two RDTs per lot at the lower parasite density or by a single RDT per lot at the higher parasite density. As each sample is tested with RDTs from two lots, for a sample to be positive at the lower parasite density, it must show a positive result in four tests (two RDTs per lot for two lots); at the higher parasite density, it must show a positive result in two tests (one RDT per lot for two lots). Thus, the PDS is a combined measure of positivity rate, incorporating inter-test and inter-lot consistency. As all tests performed on each sample must show a positive result for the sample to be considered positive, the PDS for a given RDT will usually be lower than a simple positivity rate per panel, measured by comparing the number of positive tests among all tests performed per panel. The PDS is also different from clinical sensitivity: the ability of the test to detect malaria infection in a given population of infected patients. Boxes 1 and 2 illustrate how the PDS is calculated and how it differs from a simple positivity rate for all samples tested and from clinical sensitivity in a population.
The PDS for a given RDT is different from the clinical sensi-tivity of that RDT (also called the true positive rate), which is a measure of the proportion of people known to have the disease who test positive for it. The sensitivity of malaria RDTs is highly dependent on local conditions, including the parasite density in the population; it therefore varies among populations with different levels of transmission, as their level of immunity affects the parasite density at which they exhibit symptoms that warrant a diagnostic test. Where transmission rates are low, the parasite densities in people with symptoms of malaria are likely to be low, and tests will be less sensitive. Test performance at 200 parasites/µL is therefore particularly important. The results in this report show the comparative performance of RDTs and indicate which products are likely to be more sensitive in the field, particularly in populations with low-density infections.
In general, as countries reduce the prevalence of malaria and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the high PDS at 2000 parasites/µL indicates, the sensitivity of many of these products is similar in populations with higher parasite densities and therefore it is not possible to discriminate RDTs with superior performance.
Box 2: Performance measures in WHO product testing and in field settings: PDS versus clinical sensitivity
WHO Malaria RDT Product TestingPrimary performance measure: PDS indicates which products are likely to be more sensitive in the field, particularly in populations with low‐density infections.
200 parasites/μL
2000 parasites/μL
Reference panels: two fixed parasite densities allows discrimination in RDT performance.
Malaria endemic settingPerformance measure: sensitivity is the proportion of the population studied who have malaria for whom the test is positive.
- high, moderate, low transmission- immune, non-immune- vulnerable groups
Patients have varying parasite density. Most RDTs for P. falciparum and P. vivax perform well for a parasite density > 2000 parasites/μL, but clinically significant densities < 200 parasites/μL may be missed. The “overall” test performance will nevertheless be classified as very good in a field evaluation.
54 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
An important caveat to estimating field sensitivity from the PDS provided in this report is that the panels used include only parasites known to express the target antigens. While non-expression of the target antigens has not been recorded for aldolase or pLDH, it is known that parasites that infect people in some areas of South America and India do not express HRP2 (10, 11). In areas where HRP2-deleted parasites exist, tests for HRP2 will have greatly reduced sensitivity or be incapable of detecting P. falciparum. In such populations, only tests for pLDH or aldolase in P. falciparum parasites will be effective for diagnosing falciparum malaria.
Heat stability (summarized in Table S3) is vital to maintaining the sensitivity of tests in the field. As a result, for procure-ment, careful consideration must be given to ensure that the products to be used in areas with high temperatures of transport and storage have demonstrated stability in the product testing programme. Requirements vary among countries; for example, if tests are to be deployed in areas where temperatures rarely rise above 30 °C, less emphasis is needed on stability at high temperatures than on other aspects of quality.
Ease-of-use requirements depend on the extent of training and the work environment of the users. Particularly in primary health care settings, the simpler the test, the easier it will be to avoid errors in preparation and interpretation.
Detailed results can be found in the report of each evalua-tion (3–6) and at http://www.who.int/malaria/publications/diagnostic_testing/en/.
1.4. summary of outcomesThis laboratory-based evaluation provides a comparative, standardized measure of RDT performance for distinguishing between well and poorly performing tests to serve as a basis for procurement decisions by malaria control programmes and to guide United Nations procurement policy.
In round 5, the proportion of tests that achieved a PDS ≥ 75% at 200 parasites/µL is comparable to those in rounds 3 and 4 for P. falciparum (78.6%); that for P. vivax, 42.4%, is similar to that in round 4.
Several RDTs in the five rounds of testing consistently detected malaria at a low parasite density (200 parasites/µL), had low false-positive rates, are stable at tropical temperatures, are relatively easy to use and can detect P. falciparum or P. vivax infections or both.
Although the performance of the products varied widely at low parasite density (200 parasites/µL), all products had a high rate of detection of P. falciparum at 2000 or 5000 parasites/µL, as did the majority of products for P. vivax at 2000 parasites/µL.
P. falciparum tests that target the HRP2 antigen had the highest detection rates, and two previously evaluated tests that target pan-pLDH for detection of Plasmodium spp. infec-tion also achieved a good PDS. In round 5, the two poorest performing tests for detection of P. falciparum were based on P. falciparum-specific pLDH detection. Thus, the choice of well-performing pLDH-based P. falciparum tests remains limited, as it does for pan-only-specific tests.
Test performance sometimes varied between lots and widely between similar products, confirming the advisability of testing lots after purchase and before use in the field. Furthermore, anomalies that interfered with test interpreta-tion were regularly recorded during round 5 (Annex S2). All products had issues with red background and with incomplete clearing, and cases of samples failing to flow or migrate on the RDT were reported for 62% of products.
Ninety-eight percent of the RDTs evaluated in round 5 were in cassette format.
With regard to products retested under the compulsory resubmission requirement, one showed improved (4.8%) detection of P. falciparum and one improved (4.3%) detection of P. vivax, while six and two had diminished performance (> 5% decrease) for detection of P. falciparum (mean, 13.9%; median, 8.4%) and P. vivax (mean, 8.5%), respectively. All products except one had the same or lower false-positive rates (mean improvement, 3.7%).
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54 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
1.5. How can product testing results inform rdt procurement and use?Accurate diagnosis is vital to good malaria case management, whether based on microscopy or RDTs. The results of this report should be used to identify a short list of RDTs for procurement for use in settings where good microscopy is not available or appropriate. Box 3 lists WHO’s minimum criteria for RDT selection, and Annex S3 provides a step-by-step approach to selecting an RDT, taking into consideration local malaria transmission and illness where the tests will be used (e.g. Plasmodium species, target antigen, parasite densities, climate) and other important considerations, including ease of use in the field (Annex S2), training or retraining require-ments and lot testing.1
The tabular results in TableS2 are colour-coded to reflect achievement of WHO performance requirements for RDT procurement, and a web-based tool that allows filtering of product testing results by various parameters to assist in selecting products with the performance characteristics most suitable for a country’s health programme is available and maintained by FIND (12). Comprehensive guidance on several aspects of procurement can be found in Good practices for selecting and procuring rapid diagnostic tests for malaria and guidance on implementation in Universal access to malaria diagnosis (13, 14).
1 The WHO-FIND malaria RDT evaluation programme provides lot-testing capacity in two regional laboratories free of charge; it can be accessed at [email protected] and [email protected].
1.6. product testing and WHo programme for prequalification of diagnostics and medical devicesThe WHO prequalification of diagnostics and medical devices programme uses the results of product testing as the labora-tory evaluation component of the prequalification process for malaria RDTs. These data are used to set priorities for dossier review and inspection. Although prequalification is not currently a requirement for WHO procurement, manu-facturers are encouraged to apply for it. A list of prequalified diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
Box 3: WHO selection criteria for the procurement of RDTs
Products should be selected in line with the following set of criteria, based on the results of the assessment of the WHO Malaria RDT Product Testing Programme:
(A) For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/μL.
(B) For the detection of Plasmodium vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites/μL.
(C) The false positive rate should be less than 10%.
(D) The invalid rate should be less than 5%.
Only products meeting performance criteria outlined in A,B,C and D are recommended for procurement
76 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S1: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000-5000) parasite density (parasites/μL) and clean-negative samples
a Panel detection score: A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative, blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites
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76 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S1: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000-5000) parasite density (parasites/μL) and clean-negative samples
a Panel detection score: A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative, blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites
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98 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S2: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/μL) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
100
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98 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S2: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/μL) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
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r M
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t® M
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Ad
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Who
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aria
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est
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re™
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aria
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aria
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200 parasites/µL2000 parasites/µLFalse-positive Plasmodium spp. rate (%)Invalid rate (%)
1110 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S3: Panel detection score of malaria combination and pan-only RDTs, meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) parasite density (parasites/μL)
100
80
60
40
20
00 20 40 60 80 100
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa 100
95
90
85
80
75
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
75 80 85 90 95 100
75 80 85 90 95 100
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
60
40
20
0
60
40
20
00 20 40 60
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
1 diagnosticks MALARIA (Pan/Pf) Cassette- MPNFWBC1007.42 Core™ Malaria Pv/Pf - MAL-1900223 FalciVax™ - Rapid test for Malaria Pv/Pf - 503000254 SD BIOLINE Malaria Ag Pf/ Pf/ Pv - 05FK1005 SD BIOLINE Malaria Ag Pf/Pv - 05FK80/05FK836 Malaria pf (HRP II) / (PAN-pLDH) Antigen Detection Test Device - MFV-124R7 IND ONE STEP MALARIA ANTIGEN P.f/Pan TEST - 535-108 SD BIOLINE Malaria Ag P.f/Pan - 05FK60/05FK639 BIONOTE MALARIA P.f.& Pan Ag Rapid Test Kit - RG19-0810 diagnosticks MALARIA (Pan/Pv/Pf) Cassette - MPNVFC1007.511 ICT Malaria Dual Test - ML0312 BIONOTE MALARIA P.f.& P.v. Ag Rapid Test Kit - RG19-1213 Core™ Malaria Pan/Pv/Pf - MAL-19002614 NanoSign Malaria pf/pan Ag 3.0 - RMAP1015 Humasis Malaria P.f/P.v Antigen Test - AMFV-702516 RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST - MAL-PFV-CAS/25(100)17 Parascreen® - Rapid test for Malaria Pan/Pf - 5031002518 OnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test - 537-25-DB19 diagnosticks- Malaria (Pv/Pf) Cassette - KMVFC600220 CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO - G016121 Medisensor Malaria HRP2/pLDH (Pf/Pv) COMBO - M16122 SD BIOLINE Malaria Ag Pf/ Pan - 05FK6623 CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO - G013124 DIAQUICK Malaria P.f/Pan Cassette - Z11200CE25 Humasis Malaria P.f/Pan Antigen Test - AMAL-702526 CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO - G017127 HiSens Malaria Ag P.f/P.v Combo Card - HR312328 HiSens Malaria Ag P.f/VOM Combo Card - HR332329 Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO - M17130 Malaria Pf/Pan One Step Rapid Test - RT 2022231 CareStart™ Malaria pLDH 3 Line Test - G012132 Advanced Quality™ Rapid Malaria Test (Pf/Pan) - ITP1100533 FirstSign™ ParaView (Pan+Pf) - 2101CB-2534 Wondfo® One Step Malaria P.f/P.v Whole Blood Test - W056-C35 CareStart™ Malaria Screen - G023136 OnSite Pf/Pan Ag Rapid Test - R0113C37 Vikia® Malaria Ag Pf/Pan - 41249938 ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) - IMA-T40239 First Response® Malaria Ag. pLDH/HRP2 Combo Card Test - I16FRC
40 Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device - GM00641 ParaHIT - Total Ver. 1.0 (Device) - 55IC204-1042 Advantage Malaria Pan + Pf Card - IR23102543 GenBody™Malaria Pf/Pan Ag - MALAG10044 HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card - HR292345 Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test - MAT-PF/PAN-5046 CareStart™ Malaria/Pregnancy Combo (pLDH/HRP2/HCG) - G022147 Surestep™ Easy Malaria Pf/Pan Rapid Test Device - IMA-T40248 EzDx™ Malaria Pan/Pf Rapid Test Detection kit - RK MAL 00149 Clearview® Malaria Combo - VB1150 Malascan™ Device - Rapid test for Malaria Pf/Pan - 5040202551 ASAN Easy Test® Malaria Pf/Pan Ag - AM4650-K52 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device - MFV-124V53 OnSite Pf/Pv Ag Rapid Test - R0112C54 Advantage Malaria Card - IR21102555 BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA2556 BioTracer™ Malaria Pf/PAN Rapid Card - 1701257 ICT MALARIA COMBO - ML0258 ParaHIT - Total Ver. 1.0 (Dipstick) - 55IC203-1059 IMMUNOQUICK CONTACT MALARIA +4 - 0525K2560 ABON Malaria Pan/P.f. Rapid Test Device - IMA-B40261 MeDiPro Malaria Ag HRP2/pLDH Combo - IR-0051K62 ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 2563 ParaHIT® total (dipstick) - 55IC201-1064 Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device - 1-13-101-165 ParaHIT®fV Rapid test for P. falciparum and P.vivax Malaria - Device - 55IC402-566 AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Device - MFV-124F67 Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-32268 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device - MFV-124V69 Maleriscan® Malaria Pf/Pv - MAT-5070 OptiMAL-IT - 71002471 Malaria Pf/Pv - GM00272 Malaria Pf/ PAN - GM00473 One Step Malaria P.f/Pan Test - W56-C74 Advantage Mal Card - IR22102575 HiSens Malaria Ag P.f/P.v Card - HR282376 SD BIOLINE Malaria Ag - 05FK4077 NanoSign Malaria Pf/Pv Ag - RMAD10
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
sUM
Ma
rY
ro
Un
ds
1-5
1110 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1—5
Manufacturer Product name Catalogue No.
Product re-submission
Round
Voluntary Compulsory
Access BIo, Inc.
CareStart™ Malaria HRP2/PLDH (Pf/Pv) COMBO G0161 2, 4CareStart™ Malaria HRP2/PLDH (Pf/VOM) COMBO G0171 2, 4CareStart™Malaria HRP2 (Pf) G0141 1 5CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo G0131 1 5CareStart™Malaria pLDH (PAN) G0111 1 5
Advy Chemical Pvt. Ltd. (Affiliate of Bharat Serums & Vaccines Ltd. ) EzDx™ Malaria Pan/Pf Rapid Test Detection Kit RK MAL 001 4, 5
Biosynex IMMUNOQUICK® MALARIA falciparum 0502_K25 1 5
AZOGMalaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Devicea MFV-124R 1, 3Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 3, 5
Bhat Bio-Tech India (P) Ltd. Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 4, 5Bioland NanoSign Malaria Pf/Pan Ag RMAP10 3, 4
Blue Cross Bio-Medical (Beijing) Co., Ltd.One Step Malaria Pf Test (cassette) 522352 2, 3, 4One Step Malaria P.F/P.V Test (Cassette) 523352 4, 5
CTK Biotech, Inc.Onsite Pf Ag Rapid Test R0114C 2, 3Onsite Malaria Pf/Pan Malaria Ag Rapid Test R0113C 2, 3, 4, 5Onsite Malaria Pf/Pv Ag Rapid Test R0112C 2, 3, 4
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024 1, 3
Guangzhou Wondfo Biotech Co. Ltd.Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C 1, 3One Step Malaria P.f Testb W37-C 2, 3, 4
ICT INTERNATIONALICT Malaria Combo Cassette Test ML02 1, 3, 4ICT Malaria Pf Cassette Test ML01 1, 3ICT Malaria Dual Test ML03 3, 5
InTec Products, Inc. Advanced Quality™ One Step Malaria Pf Test ITP11002TC1/TC40 1, 3 5Humasis Co., Ltd. Humasis Malaria Pf/Pan Antigen Test AMAL-7025 4, 5
J.Mitra & Co. Pvt. Ltd.Advantage Pan Malaria Card IR013025 1 5Advantage Mal Card IR221025 1 5Advantage P.f Malaria Card IR016025 1 5
Orchid Biomedical SystemsParacheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3)c 30301025 1, 3, 4Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver.3)c 30302025 1, 3, 4
Premier Medical Corporation Ltd. First Response® Malaria Ag Combo (pLDH/HRP2)d I16FRC 1, 2, 5First Response Malaria Ag P. falciparum (HRP2) Card Test I13FRC 1 5
SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf)Cassette WB KMFC6001 2, 5
Standard Diagnostics Inc. SD BIOLINE Malaria Ag 05FK40 1, 3SD BIOLINE Malaria Ag Pf/Pan 05FK60/05FK63 1, 3, 5SD BIOLINE Malaria Antigen 05FK50/05FK53 1 5
Unimed International Inc. FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101 CB-25 2, 4
Vision Biotech (Pty) Ltd / Orgenics (Alere Healthcare (Pty) Ltd subsidaries)
Malaria Rapid Combo/Clearview® Malaria Combo VB11e 1, 3Malaria Rapid Pf /Clearview ®Malaria Pf VB01 1, 3, 5Malaria Rapid Dual/Clearview® Malaria Dual Test Device VB20e 1, 3, 5
Zephyr Biomedical Systems
Malascan™ Device - Rapid test for Malaria Pf/Pan 50402025 1, 3Parabank™ Device - Rapid test for Malaria Pan 50301025 1, 3Parascreen™ Device -Rapid test for Malaria Pan/Pf 50310025 1, 3, 4, 5Falcivax Rapid Test for Malaria Pv/Pf (device) 50300025 2, 4
a Round 1 product name error: published - Malaria Pf (HRPII)/pv-LDH) Antigen Detection Test Device Code; corrected product name: Malaria Pf (HRPII/PAN-LDH) Antigen Detection Test Device Code. No change in product code.
b In round 2, product did not pass phase-1, therefore results do not feature in summary tables. c Ver.3 was introduced after round 1d Error in WHO malaria RDT product testing: round 1 report: product code (II6FRC30) should have been ( I16FRC ), as in round 2e New company acquisition (Alere™), therefore change in product branding and catalogue numbers; VB011 to VB11 and VB020 to VB20. Manufacturer confirmed
compliance with product definition.
1312 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Tabl
e S2
: Mal
aria
RDT
pha
se-2
per
form
ance
in r
ound
s 2–
5 ag
ains
t w
ild-t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
falc
ipar
um (
Pf)
and
P. v
ivax
(Pv
) at
low
(200
)
and
high
(200
0-50
00)
para
site
den
sity
(pa
rasi
tes/
μL)
and
clea
n-ne
gati
ve s
ampl
es
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l det
ectio
n sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid r
ate
(%)l
Roun
d
200
pa
rasit
es/μ
L20
00 o
r 50
00
para
sites
/μL
200
pa
rasit
es/μ
L20
00 o
r 50
00
para
sites
/μL
Clea
n-ne
gativ
e sa
mpl
es
Pf samplesc
Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Pf o
nly
ABON
™ M
alar
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apid
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t Dev
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(Who
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f. M
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ardj
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6025
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itra
& C
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td.
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pf(H
RP II
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4BI
ONOT
E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
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ote,
Inc.
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NA
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NA
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NA
1.4
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3Ca
reSt
art™
Mal
aria
HRP
2 (P
f)jG
0141
Acce
ss B
io, I
nc.
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NA
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AN
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0N
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00.
90.
05
Care
Star
t™ M
alar
ia H
RP2/
pLDH
Pf t
est
G01
81Ac
cess
Bio
, Inc
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.0N
A10
0.0
NA
NA
0.6
NA
1.3
3.0
0.0
2Cl
earv
iew
® M
alar
ia P
.f.j
VB01
Visi
on B
iote
ch (P
ty) L
td83
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A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
3Co
re™
Mal
aria
Pf
MAL
-190
020
Core
Dia
gnos
tics
97.0
NA
100.
0N
AN
A0.
0N
A0.
01.
0 (1
98)
0.3
3di
agno
stic
ks-
Mal
aria
(Pf)
Cass
ette
WB
KMFC
6001
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
88.0
NA
100.
0N
AN
A2.
1N
A1.
40.
9 (2
35)
0.3
5di
agno
stic
ks-
Mal
aria
(Pf)
Dips
tick
WB
KMFD
6007
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
80.0
NA
99.0
NA
NA
2.5
NA
3.8
2.0
0.0
2Fi
rst R
espo
nse®
Mal
aria
Ag
P. fa
lcip
arum
(HRP
2) C
ard
Test
jI1
3FRC
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.95
.0N
A10
0.0
NA
NA
0.7
NA
0.0
0.4
0.0
5Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
94.9
NA
100.
0N
AN
A0.
7N
A1.
472.
2 (2
31)
0.2
4H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.87
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A10
0.0
NA
NA
0.0
NA
0.0
1.0
0.1
2IC
T Di
agno
stic
s M
alar
ia P
.f.j
ML0
1IC
T IN
TERN
ATIO
NAL
86.9
NA
98.0
NA
NA
0.0
NA
0.0
0.0
0.0
3IM
MU
NOQ
UIC
K CO
NTA
CT fa
lcip
arum
05
19K2
5Bi
osyn
ex81
.8N
A10
0.0
NA
NA
3.6
(139
)N
A1.
44.
0 (1
99)
0.3
3IM
MU
NOQ
UIC
K® M
ALAR
IA fa
lcip
arum
j05
02_K
25Bi
osyn
ex72
.0N
A93
.0N
AN
A3.
6N
A4.
35.
1 (2
34)
0.2
5IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f
535-
11IN
D Di
agno
stic
s In
c.61
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A99
.0N
AN
A2.
2N
A14
.71
6.0
0.1
4
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
79.0
NA
91.8
(98)
NA
NA
11.4
NA
12.9
10.6
(235
)0.
75
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.83
.7N
A98
.0N
AN
A1.
5N
A0.
00.
40.
24
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td84
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A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.3
3On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)j52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.94
.9N
A99
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Prod
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Cata
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Tabl
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(con
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1514 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l det
ectio
n sc
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False
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itive
rat
es (%
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) Ltd
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5233
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td.
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l, In
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51.
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stj
R011
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K Bi
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h, In
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Rap
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r P. f
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and
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s Lt
d.63
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0 (3
99)
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RAPI
D 1-
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HEM
A CA
SSET
TE M
ALAR
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F/PV
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TM
AL-P
FV-
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tem
s, LL
C92
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0.0
100.
00.
00.
70.
01.
54.
30.
04
Tabl
e S2
: Mal
aria
RDT
pha
se-2
per
form
ance
in r
ound
s 2–
5 ag
ains
t w
ild-t
ype
(clin
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) sa
mpl
es c
onta
inin
g P.
falc
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um (
Pf)
and
P. v
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(Pv
) at
low
(200
)
and
high
(200
0-50
00)
para
site
den
sity
(pa
rasi
tes/
μL)
and
clea
n-ne
gati
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ampl
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ontin
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sUM
Ma
rY
ro
Un
ds
1-5
1514 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
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mbe
r M
anuf
actu
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Pane
l det
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False
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Inva
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Roun
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200
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Clea
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Pv samplesd
Pf samplesc
Pv samplesd
Pf s
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Pf s
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False
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False
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False
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False
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False
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Infe
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SD B
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Mal
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Pf/ P
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c.
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100.
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c.96
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0.0
100.
00.
00.
0 (1
59)
0.0
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03.
50.
22
Trus
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Mal
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P.f.
/p.v.
test
A03-
12-3
22Ar
tron
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s In
c.88
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0.0
13.3
27.4
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94)
19.4
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32.0
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54
Won
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One
Ste
p M
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hole
Blo
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ngzh
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otec
h Co
. Ltd
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5 (3
99)
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1.5
2.9
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pan
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an/P
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s92
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3 (3
91)
0.0
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3.5
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Firs
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50.
00.
024
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12
Para
max
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100.
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96)
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0 (1
99)
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37.0
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72
Pan
only
Adva
ntag
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n M
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td.
77.0
100.
098
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NA
NA
NA
NA
0.4
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24
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84.0
88.6
99.0
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NA
NA
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0.0
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. (In
vern
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NA
NA
NA
13.5
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16.2
54.3
92.9
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AN
AN
AN
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00.
33
Firs
t Res
pons
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31.0
92.5
98.0
100.
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AN
AN
AN
A0.
00.
02
Firs
tSig
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k (P
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alar
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2104
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nim
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nc.
25.0
82.5
87.0
100.
0N
AN
AN
AN
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50.
22
OnSi
ght™
- P
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t53
9-25
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Amge
nix
Inte
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l, In
c.22
.077
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0.0
NA
NA
NA
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2.5
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pid
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5030
1025
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17.2
62.9
90.9
100.
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AN
AN
AN
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50.
23
Pv o
nly
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IOLI
NE
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Pv05
FK70
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dard
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92.5
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100.
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00.
02
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licab
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Pf, P
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odiu
m fa
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P
v, Pl
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p
an, P
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lasm
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nd m
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ple
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dere
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nly
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s fro
m b
oth
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tech
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an,
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time,
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or m
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shou
ld n
ot h
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c Ro
und
1, n
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roun
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n=1
00; r
ound
3, n
=99;
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d 4,
n=9
8; ro
und
5, n
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d Ro
und
1, n
=20;
roun
d 2,
n=4
0; ro
und
3, n
=35;
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4; ro
und
5, n
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e Fo
r com
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tion
test
s, pa
n or
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line,
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pos
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indi
cate
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falci
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316;
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00; r
ound
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ound
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Pf li
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dica
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P. fa
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n=
160;
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; rou
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g
For
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bina
tion
test
s, pa
n or
Pv
line,
onl
y, p
ositi
ve in
dica
tes
a fa
lse-
posi
tive
non-
P. fa
lcip
arum
infe
ctio
n (r
ound
1, n
=15
8; r
ound
2, n
=20
0; r
ound
3, n
=19
8;
roun
d 4,
n=1
96; r
ound
5, n
=200
)h
Pf li
ne p
ositi
ve in
dica
tes
a fa
lse-
posi
tive
P. fa
lcip
arum
infe
ctio
n (ro
und
1, n
=40
; ro
und
2, n
=80,
roun
d 3,
n=7
0; ro
und
4, n
=68;
roun
d 5,
n=7
0)i
Roun
d 1,
n=1
68; r
ound
2, n
=200
; rou
nd 3
, n=2
00; r
ound
4, n
=232
roun
d 5,
n=2
36j
Prod
uct
resu
bmis
sion
, res
ults
fro
m m
ost
rece
nt r
ound
of
test
ing
repl
ace
prev
ious
re
sults
. Ref
er to
Tab
le S
1.
k PD
S pr
esen
ted
in th
e ta
ble
is b
ased
on
a po
sitiv
e pf
test
line
(eith
er p
f-H
RP2
or p
f-pL
DH).
For t
est l
ine-
spec
ific
resu
lts re
fer t
o th
e ta
bles
and
ann
exes
in th
e fu
ll re
port
s.l
Rou
nd 1
, n=
954;
rou
nd 2
, n=
1240
; ro
und
3, n
=12
04;
roun
d 4,
n=
1192
; Ro
und
5, n
=121
4
Perf
orm
ance
mea
sure
Reco
mm
ende
d W
HO
pr
ocur
emen
t cr
iteria
Pa
nel d
etec
tion
scor
e fo
r Pf a
nd P
v 20
0/µL
sam
ples
≥ 75
%
Fals
e-po
sitiv
e ra
tes
agai
nst c
lean
-neg
ativ
es
< 10
%
Inva
lid ra
te<
5% o
f tes
ts c
ondu
cted
Tabl
e S2
(con
tinue
d)
1716 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Tabl
e S3
: Mal
aria
RDT
rou
nds
2—5
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. fa
lcip
arum
sam
ple
at lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L).
Posi
tivi
ty r
ate
at b
asel
ine
and
afte
r 60
day
s’ in
cuba
tion
at 3
5 °C
and
45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Roun
d20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Pf o
nly
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td15
.015
.017
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
taIT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.93
.396
.790
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5
Adva
ntag
e P.
f. M
alar
ia C
arda
IR01
6025
J. M
itra
& C
o. P
vt. L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.10
0.0
100.
086
.710
0.0
90.0
80.0
NA
NA
NA
NA
NA
NA
3Ca
reSt
art™
Mal
aria
HRP
2 (P
f)aG
0141
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5Ca
reSt
art™
Mal
aria
HRP
2/pL
DH P
f tes
tG
0181
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
2Cl
earv
iew
® M
alar
ia P
.f.a
VB01
Visi
on B
iote
ch (P
ty) L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3di
agno
stic
ks-
Mal
aria
(Pf)
Cass
ette
WBa
KMFC
6001
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5di
agno
stic
ks-
Mal
aria
(Pf)
Dips
tick
WB
KM
FD60
07SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A2
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Car
d Te
sta
I13F
RCPr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A2
ICT
Diag
nost
ics
Mal
aria
P.f.
aM
L01
ICT
Inte
rnat
iona
l10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3IM
MU
NOQ
UIC
K® M
ALAR
IA fa
lcip
arum
a05
02_K
25Bi
osyn
ex10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
100.
010
0.0
86.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5M
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4N
anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)a
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
OnSi
ght™
- M
alar
ia P
f Tes
t51
1-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.10
0.0
95.0
90.0
100.
010
0.0
65.0
NA
NA
NA
NA
NA
NA
2On
Site
Pf A
g Ra
pid
Test
a R0
114C
CTK
Biot
ech,
Inc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)j
3020
3002
5Or
chid
Bio
med
ical
Sys
tem
s 10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dip
stic
k (V
er.3
)j30
2040
025
Orch
id B
iom
edic
al S
yste
ms
100.
096
.710
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Para
HIT
® -
f (De
vice
) 55
IC10
4-50
Span
Dia
gnos
tics
Ltd.
100.
096
.710
0.0
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
3Pa
raH
IT®
-f (D
ipst
ick)
55IC
103-
50Sp
an D
iagn
ostic
s Lt
d.10
0.0
100.
056
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3SD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
)b05
FK90
Stan
dard
Dia
gnos
tics
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3SD
BIO
LIN
E M
alar
ia A
g Pf
a05
FK50
/05F
K53
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-01
-322
Artr
on L
abor
ator
ies
Inc.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5W
ondf
o On
e St
ep M
alar
ia P
.f Te
sta
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.10
0.0
96.7
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pf
and
pan
ABON
Mal
aria
Pan
/P.f.
Rap
id T
est D
evic
e IM
A-B4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td.
100.
080
.090
.010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3AB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
0
ACCU
CARE
ON
E ST
EP M
ALAR
IA P
f/Pa
n An
tigen
Tes
tM
AGC
25LA
B-CA
RE D
iagn
ostic
s (In
dia)
PVT
. LT
D.83
.373
.310
.010
0.0
100.
010
0.0
3.3
10.0
0.0
70.0
90.0
30.0
5
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
86.7
96.7
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
70.0
100.
080
.05
Adva
ntag
e M
al C
arda
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
100.
010
0.0
100.
00.
00.
00.
070
.010
0.0
80.0
5
sUM
Ma
rY
ro
Un
ds
1-5
1716 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Roun
d20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
80.0
93.3
26.7
100.
010
0.0
100.
05
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ceb
MFV
-124
FAZ
OG, I
NC.
96.7
96.7
100.
010
0.0
100.
010
0.0
3.3
0.0
0.0
20.0
0.0
0.0
4
BIOC
REDI
T M
alar
ia A
g Pf
/Pan
(HRP
II/pL
DH)
C30R
HA2
5Ra
piG
EN IN
C.10
0.0
100.
096
.790
.010
0.0
100.
00.
053
.30.
090
.010
0.0
100.
05
BION
OTE
MAL
ARIA
P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
-08
Bion
ote,
Inc.
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
090
.03
BioT
race
r™ M
alar
ia P
f/PA
N R
apid
Car
d17
012
Bio
Focu
s Co
., Lt
d.10
0.0
96.7
90.0
100.
010
0.0
100.
00.
00.
066
.710
0.0
100.
010
0.0
5Ca
reSt
art™
Mal
aria
/Pre
gnan
cy C
ombo
(pLD
H/H
RP2/
HCG
) G
0221
Acce
ss B
io In
c10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
03
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOa
G01
31Ac
cess
Bio
, Inc
.10
0.0
100.
096
.710
0.0
100.
010
0.0
93.3
86.7
53.3
100.
010
0.0
100.
05
Care
Star
t™ M
alar
ia p
LDH
3 L
ine
Test
G
0121
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
3Ca
reSt
art™
Mal
aria
Scr
een
G02
31Ac
cess
Bio
, Inc
.10
0.0
100.
093
.310
0.0
100.
010
0.0
100.
010
0.0
93.3
100.
010
0.0
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03
Clea
rvie
w®
Mal
aria
Com
boa
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Visi
on B
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ch (P
ty) L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
090
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.00.
03
Clea
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w®
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lVB
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geni
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S)10
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010
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010
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100.
00.
010
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390
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re™
Mal
aria
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Pf
MAL
-190
024
Core
Dia
gnos
tics
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100.
010
0.0
100.
010
0.0
100.
010
0.0
26.7
80.0
83.3
100.
010
0.0
100.
04
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC 10
07.4
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Diag
nost
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& B
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ch S
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100.
010
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96.7
100.
010
0.0
100.
00.
00.
00.
010
0.0
90.0
90.0
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AQU
ICK
Mal
aria
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ette
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AB G
mbH
100.
010
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96.7
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
080
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EzDx
™ M
alar
ia P
an/P
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est D
etec
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kita
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AL 0
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vy C
hem
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ms
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0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
03.
310
0.0
100.
010
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5
Firs
t Res
pons
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alar
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g. p
LDH
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sta
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tion
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100.
010
0.0
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010
0.0
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010
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0.0
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0.0
100.
010
0.0
100.
05
Firs
tSig
n™ P
araV
iew
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nim
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tern
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96.7
100.
010
0.0
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010
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100.
00.
00.
013
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0.0
100.
010
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enBo
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100
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100.
010
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93.3
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010
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00.
050
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ened
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Pan
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apid
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t 20
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n Cr
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edica
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orp.
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100.
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30.
013
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00.
00.
05
HiS
ens
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aria
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P.f/
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Card
H
R282
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BI C
o., L
td.
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010
0.0
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00.
00.
00.
035
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00.
02
HiS
ens
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aria
Ag
Pf/P
v (H
RP2/
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dH
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3H
BI C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
95.0
100.
010
0.0
100.
02
Hum
asis
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aria
P.f/
Pan
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en T
estj
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-702
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umas
is, C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
100.
05
ICT
Mal
aria
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l Tes
taM
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ICT
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rnat
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0.0
100.
010
0.0
100.
010
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00.
00.
00.
090
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MAL
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BOa
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T In
tern
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nal
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96.7
93.3
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010
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03.
320
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ALAR
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0.0
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010
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00.
00.
00.
050
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D ON
E ST
EP M
ALAR
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NTI
GEN
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Pan
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D Di
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100.
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333
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4M
alar
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an T
est
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ma
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sells
chaf
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60.0
33.3
23.3
100.
010
0.0
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53.3
40.0
10.0
60.0
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3M
alar
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f./Pa
n An
tigen
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70.
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0.0
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010
0.0
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alar
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f (H
RP II
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AN-p
LDH
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igen
Det
ectio
n Te
st D
evic
eaM
FV-1
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AZOG
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
03
Mal
aria
pf (
HRP
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AN (p
LDH
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igen
Det
ectio
n Te
st D
evic
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13-1
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ted
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ech,
Inc.
10
0.0
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96.7
100.
010
0.0
100.
016
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00.
090
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Mal
aria
pf (
pLDH
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AN-p
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t Dev
ice
aM
FV-1
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OG, I
nc.
46.7
56.7
66.7
100.
010
0.0
100.
013
.393
.310
0.0
60.0
100.
010
0.0
5M
alar
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f/ P
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nom
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olec
ular
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gnos
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d.56
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100.
010
0.0
0.0
0.0
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90.0
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alar
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f/Pa
n On
e St
ep R
apid
Tes
tRT
202
22Zh
ejia
ng O
rient
Gen
e Bi
otec
h Co
., Ltd
.10
0.0
100.
096
.710
0.0
90.0
100.
00.
00.
00.
010
0.0
90.0
100.
05
Mal
asca
n™ D
evic
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Rapi
d te
st fo
r Mal
aria
Pf/
Pana
5040
2025
Zeph
yr B
iom
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yste
ms
96.7
100.
096
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0.0
100.
010
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0.0
0.0
6.7
100.
010
0.0
100.
03
MD
Mal
aria
Pf/
Pan(
pLDH
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tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
100.
05
MeD
iPro
Mal
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Ag
HRP
2/pL
DH C
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osa
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chno
logy
Cor
p.10
0.0
96.7
96.7
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
04
Nan
oSig
n M
alar
ia p
f/pa
n Ag
3.0
aRM
AP10
Biol
and
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
100.
04
Nan
oSig
n M
alar
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f/Pv
Ag
RMAD
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olan
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td0.
00.
00.
020
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00.
00.
00.
00.
00.
00.
00.
03
NG
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t MAL
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Pf/
Pan
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H)
NG-M
AL-W
23-0
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RL N
G B
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ch, Z
.A.
100.
010
0.0
100.
010
0.0
100.
010
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6.7
0.0
100.
010
0.0
100.
05
One
Step
Mal
aria
P.f/
Pan
Test
a W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.46
.713
.326
.710
0.0
100.
010
0.0
0.0
36.7
73.3
70.0
80.0
100.
03
Tabl
e S3
(con
tinue
d)
(con
tinue
d)
1918 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Roun
d20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
OnSi
te P
f/Pa
n Ag
Rap
id T
esta
R011
3CCT
K Bi
otec
h, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
03.
390
.010
0.0
100.
05
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
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00.
00.
010
0.0
90.0
0.0
0.0
0.0
0.0
100.
090
.00.
03
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
4Pa
raH
IT -
Tot
al V
er. 1
.0 (D
ipst
ick)
55IC
203-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
93.3
46.7
100.
010
0.0
60.0
50.0
0.0
0.0
100.
090
.00.
04
Para
HIT
® to
tal (
dips
tick)
55IC
201-
10Sp
an D
iagn
ostic
s Lt
d55
.085
.055
.010
0.0
100.
095
.010
.00.
00.
050
.045
.070
.02
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
fa50
3100
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
010
.03.
313
.310
0.0
100.
010
0.0
5Ri
ghtS
ign™
Mal
aria
P.f.
/Pan
Rap
id T
est C
asse
tte
IMPN
-C52
Han
gzho
u Bi
otes
t Bio
tech
Co.
Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
020
.010
0.0
100.
060
.010
0.0
5SD
BIO
LIN
E M
alar
ia A
g P.
f/Pa
na
05FK
60/0
5FK6
3St
anda
rd D
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ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
5SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
05FK
66St
anda
rd D
iagn
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s In
c.
96.7
96.7
100.
090
.010
0.0
100.
016
.610
.00.
090
.010
0.0
100.
04
SD B
IOLI
NE
Mal
aria
Aga
05FK
40St
anda
rd D
iagn
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s In
c.0.
00.
00.
010
0.0
80.0
90.0
0.0
0.0
0.0
80.0
20.0
90.0
3Su
rest
ep™
Eas
y M
alar
ia P
f/Pa
n Ra
pid
Test
Dev
ice
IMA-
T402
ACON
Bio
tech
(Han
gzho
u) C
o. L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3Vi
kia®
Mal
aria
Ag
Pf/P
an41
2499
IMAC
CESS
S.A
.S10
0.0
96.7
96.7
100.
010
0.0
100.
00.
00.
00.
060
.060
.00.
05
Pf a
nd P
v/Pv
omAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
100.
096
.796
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3AS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
100.
096
.763
.310
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5BI
ONOT
E M
ALAR
IA P
.f.&
P.v.
Ag
Rapi
d Te
st K
it RG
19-1
2Bi
onot
e,In
c.10
0.0
96.7
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOa
G01
61Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOa
G01
71Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3di
agno
stic
ks-
Mal
aria
(Pv/
Pf) C
asse
tte
KMVF
C600
2SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s10
0.0
95.0
95.0
100.
010
0.0
95.0
NA
NA
NA
NA
NA
NA
2Fa
lciV
ax™
- R
apid
test
for M
alar
ia P
v/Pf
a50
3000
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
HiS
ens
Mal
aria
Ag
P.f/
P.v
Com
bo C
ard
HR3
123
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
HiS
ens
Mal
aria
Ag
P.f/
VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
10
0.0
100.
010
0.0
90.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e M
FV-1
24V
AZOG
, Inc
.10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3M
alar
ia P
f (H
RPII)
/ PV
(PLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
GM
006
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
. Ltd
.83
.390
.083
.310
0.0
90.0
70.0
NA
NA
NA
NA
NA
NA
5M
alar
ia P
f/Pv
GM
002
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
40.0
33.3
40.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
Mal
eris
can®
Mal
aria
Pf/
Pv
MAT
-50
Bhat
Bio
-Tec
h In
dia
(P) L
td10
0.0
60.0
30.0
100.
090
.095
.0N
AN
AN
AN
AN
AN
A2
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
1M
edis
enso
r, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOM
171
Med
isen
sor,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4On
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)a52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5On
Sigh
t™ -
Par
aQui
ck-2
(Pv,P
f) M
alar
ia T
est
537-
25-D
BAm
geni
x In
tern
atio
nal,
Inc.
100.
010
0.0
100.
010
0.0
100.
085
.0N
AN
AN
AN
AN
AN
A2
OnSi
te P
f/Pv
Ag
Rapi
d Te
sta
R011
2CCT
K Bi
otec
h, In
c.10
0.0
100.
090
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
raHI
T®fV
Rap
id te
st fo
r P. f
alcip
arum
and
P. v
ivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.10
0.0
96.7
96.7
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
5
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vb05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
100.
010
0.0
96.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
v05
FK80
/05F
K83
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
095
.0N
AN
AN
AN
AN
AN
A2
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.10
0.0
100.
036
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4W
ondf
o® O
ne S
tep
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
tW
056-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
100.
096
.793
.310
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5
Tabl
e S3
: Mal
aria
RDT
rou
nds
2—5
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. fa
lcip
arum
sam
ple
at lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L).
Posi
tivi
ty r
ate
at b
asel
ine
and
afte
r 60
day
s’ in
cuba
tion
at 3
5 °C
and
45
°C (c
ontin
ued)
sUM
Ma
rY
ro
Un
ds
1-5
1918 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Roun
d20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Pf, P
v an
d pa
nCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
100.
010
0.0
100.
010
0.0
90.0
100.
00.
00.
00.
080
.050
.070
.03
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s96
.710
0.0
93.3
100.
010
0.0
100.
00.
00.
00.
070
.00.
050
.03
Firs
tSig
n™ -
Par
aVie
w-3
(Pan
+Pv+
Pf) M
alar
ia T
est
2103
CB-
25U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
60.0
50.0
15.0
100.
090
.010
0.0
2Pa
ram
ax-3
Rap
id T
est f
or M
alar
ia P
an/P
v/Pf
(dev
ice)
5032
0025
Zeph
yr B
iom
edic
als
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
025
.030
.010
0.0
95.0
100.
02
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
arda
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
NA
NA
NA
NA
NA
NA
36.7
66.7
60.0
100.
010
0.0
90.0
5AZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.N
AN
AN
AN
AN
AN
A10
0.0
100.
010
0.0
100.
010
0.0
100.
04
Care
Star
t™ M
alar
ia p
LDH
(PAN
)aG
0111
Acce
ss B
io, I
nc.
NA
NA
NA
NA
NA
NA
100.
010
0.0
100.
010
0.0
100.
010
0.0
5
Clea
rvie
w®
Mal
aria
pLD
Ha
7088
4025
Org
enic
s Lt
d. (
Inve
rnes
s M
edic
al
Inno
vatio
ns)
NA
NA
NA
NA
NA
NA
96.7
93.3
100.
010
0.0
100.
010
0.0
3
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
NA
NA
NA
NA
NA
NA
0.0
0.0
0.0
80.0
100.
080
.03
Firs
t Res
pons
e® M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
NA
NA
NA
NA
NA
NA
50.0
80.0
55.0
100.
010
0.0
100.
02
Firs
tSig
n™ -
Pan
Chec
k (P
an) M
alar
ia T
est
2104
CB-
25U
nim
ed In
tern
atio
nal I
nc.
NA
NA
NA
NA
NA
NA
25.0
5.0
10.0
100.
010
0.0
100.
02
OnSi
ght™
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.N
AN
AN
AN
AN
AN
A5.
035
.015
.010
0.0
100.
010
0.0
2Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
ana
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
NA
NA
NA
NA
NA
NA
0.0
0.0
0.0
90.0
100.
010
0.0
3Pv
onl
ySD
BIO
LIN
E M
alar
ia A
g Pv
05FK
70St
anda
rd D
iagn
ostic
s, In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A2
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
Indi
cate
s re
sults
for t
hose
pro
duct
s th
at m
eet a
ll W
HO
reco
mm
ende
d pr
ocur
emen
t crit
eria
a Pr
oduc
t res
ubm
issi
on, r
esul
ts fr
om m
ost r
ecen
t rou
nd o
f tes
ting
repl
ace
prev
ious
resu
lts. R
efer
to T
able
S1.
b
Resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a P
f tes
t lin
e (e
ither
Pf-
HRP
2 or
Pf-
pLDH
). Re
sults
bas
ed o
n st
abili
ty o
f ind
ivid
ual t
est l
ines
is p
rese
nted
in th
e fo
llow
ing
tabl
e:
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (P
f lin
e)Pe
rcen
tage
pos
itive
tes
t re
sults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (p
an li
ne)
Roun
d20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL20
0 pa
rasit
es/μ
L20
00 p
aras
ites/
μL
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH) -
(PF(
HRP
2) li
ne)
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
AN
ASD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
)- (P
F(pL
DH) l
ine)
05
FK90
Stan
dard
Dia
gnos
tics
Inc.
0.0
0.0
0.0
33.3
33.3
33.3
NA
NA
NA
NA
NA
NA
NA
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ce -
(PF(
HRP
2) li
ne)
MFV
-124
FAZ
OG, I
NC.
96.7
96.7
100.
010
0.0
100.
010
0.0
3.3
0.0
0.0
20.0
0.0
0.0
4
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ce -
(PF(
pLDH
) lin
e)M
FV-1
24F
AZOG
, IN
C.13
.33.
36.
750
.010
.050
.03.
30.
00.
020
.00.
00.
04
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v -
(PF(
HRP
2) li
ne)
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pf/
Pv
- (P
F(pL
DH) l
ine)
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
26
.73.
33.
310
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
Tabl
e S3
(con
tinue
d)
2120 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
2. WHo Malaria rdt prodUct testing: roUnd 5: eXecUtiVe sUMMarY
2.1. introductionWHO estimates that half the world’s population is at risk of malaria. In 2012, there were an estimated 207 million cases (with an uncertainty range of 135 million to 287 million) and an estimated 627 000 deaths (with an uncertainty range of 473 000 to 789 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under 5 years. Malaria remains endemic in 104 countries, and, while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of antimalarial drugs and poor disease monitoring (1).
WHO recommends that malaria case management be based on parasite diagnosis in all cases (2). The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained.The data generated by the WHO and FIND programme to evaluate and compare the performance of commercially available malaria RDTs are guiding procurement decisions, which, in turn, have shifted markets towards better performing tests and helped to improve the quality of manufacturing. The results of WHO malaria RDT product testing form the basis of procurement criteria and constitute the laboratory evaluation component of WHO prequalification for malaria RDTs. This report provides the results of round 5 of product testing, performed at the CDC in 2013, with data on the performance of 42 products. This evaluation adds to the evaluations of rounds 1–4 (3–6), which should be considered as a single evaluation, except that the results for products tested in previous rounds that were resubmitted for testing replace those reported previously. From round to round, the evaluation panels are essentially the same (Annex S1), and the same or slightly modified testing protocols are followed. This report extends the data from previous rounds and therefore increases the number of RDTs available for procurement for which detailed, comparative data are available on aspects of performance relevant to field use. The report provides updated data on the performance of products at least every 5 years, as a result of implementation of the compulsory resubmission policy. Products that are not resubmitted are deleted from the summary results of WHO product testing and are not eligible for WHO procurement.
2.2. the WHo product testing programmeProduct testing is part of the WHO-FIND malaria RDT evalu-ation programme, which develops methods for evaluation and provides data on antigen-detecting malaria RDTs. The programme is a collaboration among many institutions in malaria-endemic and non-endemic countries, with a global specimen bank and testing performed at the CDC (Fig. 2).
All companies that manufacture according to ISO 13485:2003 quality system standards were invited to submit one test for evaluation in the programme, except manufacturers who were required to submit additional products under the new compulsory resubmission rules. The 42 products from 34 manufacturers1 were evaluated with prepared blood panels of cultured P. falciparum parasites, patient-derived wild-type P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive assessment of ease of use was recorded. As for previous rounds, RDTs are grouped in the tables and figures into those that detect P. falciparum only, various combination tests and those that have only a pan-specific (or P. vivax-specific) line. Manufacturers submitted two lots of each product for evaluation. The 23 products that had been tested in previous rounds comprised 10 compulsory resubmissions and 13 voluntary resubmissions (Table 1a,b).
The aim of the evaluation is to provide comparative data on the performance of the submitted production lots of each product against samples containing low (200 parasites/µL) and high densities (2000 or 5000 parasites/µL) of P. falci-parum or P. vivax. Because the concentration of target antigens in samples with the same parasite density is variable, the evaluation panel selection process is adjusted to ensure that there is no statistically significant difference in mean or median antigen concentrations for HRP2, aldolase and pLDH between panels used in different rounds of testing (Annex S1, Table 3).
The data in this report are used to guide procurement decisions by WHO, other United Nations agencies and national govern-ments. Product testing is part of a continuing programme to improve the quality of RDTs that are used and to support widespread, reliable malaria diagnosis in areas where malaria is prevalent. A sixth round of product testing began in June 2014, and the results will be published in 2015.
1 Several manufacturers are subsidiaries of Alere™ .
eXec
Uti
Ve s
UM
Mar
Y ro
Un
d 5
2120 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
2.3. results of the evaluation The results (summarized in Tables 4–6 and Figs 10, 11, 14 and 15) provide a comparison of two lots of products against a panel of parasite samples diluted to a low parasite density (200 parasites/µL), considered to be close to the threshold that tests must detect in order reliably to identify clinical malaria in many settings (9), and a higher parasite density (2000 or 5000 parasites/µL).
For the purposes of this report, the main measure of perfor-mance is the PDS, the percentage of malaria samples in a panel that give a positive result in two RDTs per lot at the lower parasite density and a single RDT per lot at the higher parasite density. Thus, it is not a measure of clinical sensitivity or of the positivity rate against the panel but rather a combined measure of positivity rate and inter-test and inter-lot consistency.
As for products evaluated in previous rounds of product testing, the PDS varies widely, some products showing high performance in detecting parasites, in thermal stability and other performance measures. Overall, there is no obvious trade-off between the PDS (or positivity rate) and the false-positive rate, which are surrogates for sensitivity and specificity in the field, respectively. Furthermore, a number of tests showed good outcomes for both these indicators.
The basis for P. falciparum detection by combination RDTs (P. falciparum/pan, P. falciparum/P. vivax, P. falciparum/P. vivax, ovale and malariae), particularly in samples with low parasite density, is predominantly detection of HRP2 and not pLDH. In other words, mainly the HRP2 test band reacts with P. falciparum-containing samples, probably reflecting poorer affinity of the monoclonal pLDH antibodies on the pLDH test band and not HRP2 persistent antigenaemia, as all samples are known to contain P. falciparum (and pLDH).
In round 5, the results for 80% (8/10) and 75% (3/4) of the compulsorily retested products were within 10% of the initial test for detection of P. falciparum and P. vivax at 200 parasites/µL. Most of the differences detected were decreases in performance in comparison with previous testing. Among the voluntary resubmissions, 77% (10/13) and 73% (8/11) of products showed better detection of P. falciparum and P. vivax at 200 parasites/µL, respectively. Detection of P. falciparum improved by 11% on average, while the mean improvement in P. vivax detection was 29%. Two products, however, showed significantly increased (> 75%) false-positive rates in round 5. In combination tests, there was no significant correlation between improvements in P. falciparum and P. vivax detection, suggesting that changes in detection of these two parasite species occurred independently of each other.
Several products had very high false-positive rates for P. falciparum against clean negatives, and, as previously reported, high false-positive rates were seen with several products against blood samples containing specific immu-nological abnormalities (e.g. rheumatoid factor, anti-mouse antibodies) (Table A4.9). The number of samples evaluated was, however, small, and the clinical significance of these
results is limited, although they may be important in certain populations with very low parasite prevalence.
Some products showed variation in performance between the two lots evaluated, confirming the advisability of lot-testing before field use.
Heat (thermal) stability varied widely, some products retaining high positivity rates after 2 months’ storage at 45 °C and 75% humidity. For many products, pan-line performance at baseline and post-heat stress for detection of the P. falci-parum isolate were poor and nearly universally poor against low parasite density samples, making true stability difficult to assess.
The majority of the products evaluated showed a variable frequency of anomalies that could interfere with test inter-pretation, the most common being a red background and incomplete clearing (Table 8).
The clinical sensitivity of an RDT, i.e. the proportion of people known to have the disease who test positive for it, is highly dependent on local conditions, including the parasite density in the target population, and therefore varies among populations with differing levels of transmission. The results in this report show comparative performance between RDTs, and give an indication of which products are likely to provide higher sensitivity in the field, particularly in populations with low-density infections. In general, as countries reduce malaria prevalence and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the PDS at 2000 parasites/µL indicates, the sensitivity of many of these products will be similar in populations with higher parasite densities, although a subset of any population will include vulnerable individuals who may develop illness at low parasite densities (e.g. young children, pregnant women, those well protected by bed nets) and must always be taken into account when interpreting RDT results. For areas where significant non-expression of HRP2 is known, the results of HRP2-detecting tests in this report should not be considered to predict sensitivity in the field. Only tests targeting P. falciparum by detection of pLDH or aldolase should be considered.
Heat stability (summarized in Table 6) is vital to maintaining the sensitivity of a test in the field. For procurement, there-fore, the results for stability should be used to ensure that products to be used in areas with high temperatures during transport and storage have demonstrated good stability in the product testing programme. The requirements vary by country; for example, if tests are to be used in areas where the temperature rarely rises above 30 °C, stability at high temperatures is less important.
The requirements for ease of use depend on the extent of training and the work environment of users. Particularly in primary health care settings, the simpler the test, the easier it should be to avoid errors in preparation and interpretation.
2322 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
2.4. Use of the results
Box 3 outlines WHO’s minimum criteria for selecting RDTs, and tabular results in Tables S2 and 5 are colour-coded to reflect achievement of these requirements, and a web-based tool that allows filtering of product testing results by various parameters to assist in selecting products with the performance characteristics most suitable for a country’s health programme is available and maintained by FIND (12). Annex S3 provides a step-by-step approach to selecting an RDT, taking into consideration local conditions of malaria
transmission and illness (e.g. Plasmodium species, target antigen variation, parasite densities, climate), and other important considerations, including ease of use in the field, for training and retraining and lot testing. RDTs must not be procured without programme and infrastructure preparation for proper use, including supply chain management, training in test usage and disposal, and training in patient management in response to results. Comprehensive guidance on several aspects of procurement can be found in Good practices for selecting and procuring rapid diagnostic tests for malaria and guidance on implementation in Universal access to malaria diagnosis (13, 14).
3. backgroUnd
During the past decade, new opportunities for the control of malaria have emerged, including use of long-lasting insecticidal nets, indoor residual spraying of insecticides and artemisinin-based combination therapy. These have been shown to reduce the burden of malaria infection in countries where they are adequately implemented. Therefore, the proportion of febrile episodes attributable to malaria is likely to decrease substantially.
Despite WHO’s recommendation for a parasitologically confirmed diagnosis of malaria infection before treatment in all cases (2), diagnoses are still often made on clinical grounds (9), whereas in most endemic areas malaria accounts for a minority of cases of “malaria-like” febrile illness. Microscopy has been the cornerstone of diagnosis and is recommended
for malaria diagnosis when its quality can be maintained; however, the need for trained personnel and adequate reagents and equipment limits its availability and acces-sibility in malaria-endemic areas. Rapid, accurate, accessible diagnostic tools are increasingly required as programmes extend parasite-based diagnosis and the prevalence of malaria decreases. RDTs to detect Plasmodium-specific antigens (proteins) in whole blood of infected people have emerged as an attractive alternative to microscopy. The currently available RDTs come in various formats (dipstick, cassette or hybrids) and contain antibodies bound to specific antigens, such as HRP2 specific to P. falciparum, pan-specific and species-specific pLDH or aldolase specific to all the major Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) (Fig. 1).
Figure 1: Mode of action of antigen-detecting malaria RDTs
a
b
c
Bound Ab
Free labelledAb
Captured Ag–labelledAb complex
Capturedlabelled Ab
Parasite Agcaptured bylabelled Ab
Labelled Ab–Agcomplex capturedby bound Ab oftest band
Lysing agentand labelled Ab
Test line(bound Ab)*
Parasitized blood
Bu�er/�ushing agent
Control line(bound Ab)*
Nitrocellulose strip
Blood and labelled Ab �ushed along strip
*Not normally visible
Labelled Abcaptured by bound Ab ofcontrol band
Mode of action of common malaria RDT format:
(a) Dye-labelled antibody (Ab), specific for the target antigen, is present on the lower end of the nitrocellulose strip or in a well provided with the strip. Antibody, also specific for the target antigen, is bound to the strip in a thin (test) line, and either antibody specific for the labeled antibody, or antigen (Ag), is bound at the control line.
(b) Blood and buffer, which have been placed on the strip or in the well, are mixed with the labelled antibody and are drawn up the strip across the lines of bound antibody.
(c) If antigen is present, some labelled antibody will be trapped on the test line. Other labelled antibody is trapped on the control line.
eXec
Uti
Ve s
UM
Mar
Y ro
Un
d 5
2322 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
To be widely useful, an RDT must be highly sensitive to ensure detection of all clinically significant malaria infections, highly specific to allow monitoring of low malaria prevalence and appropriate management of non-malarial fevers and highly stable to allow transport and storage in ambient conditions in malaria-endemic areas. Published field trials of RDTs show highly variable performance, probably due to poor manufacturing quality, incorrect storage and handling, poor preparation and interpretation, and sometimes poor study methods, analysis and reporting (15–23). In general, diagnostic testing by microscopy or RDT to a level of 200 parasites/µL will reliably detect nearly all clinically relevant infections in malaria-endemic areas (9).
The number of RDTs available on the market has grown rapidly since their introduction in the late 1990s, with an estimated 60 brands and over 200 tests commercially available today and 205 million tests or more procured in 2012 (1). Regulatory control of diagnostics is, however, often weak, and procure-ment agencies have had considerable difficulty in selecting appropriate RDTs and ensuring their quality. In view of the inconsistency in the results of field studies and the inherent difficulties in assessing large numbers of products in a
standardized way in field trials, WHO and partners embarked on a programme to evaluate RDTs for malaria in 2002 to ensure standardized assessment of performance and to guide procurement decisions and regulatory mechanisms. Between 2003 and mid-2012, the programme was managed by WHO and TDR in partnership with FIND. After TDR withdrew its involvement in 2012, the WHO Global Malaria Programme assumed a coordinating role. A steering committee oversees the development of and modifications to standard operating procedures (24,25). A network of specimen collection sites has been established to provide specimens for a global bank at the CDC and to facilitate local quality control (Fig. 2).
The reports of the previous four rounds of product testing have been released annually since 2009 (3–6). This fifth report adds data on the performance of 19 new products and updated data on 23 resubmitted RDTs. Testing for round 5 was conducted against an evaluation panel with similar characteristics to previous panels in terms of overall antigen concentration, parasite origin and parasite-negative blood samples (Annex S1). Most panel samples were retained from previous rounds, with 36 of 100 P. falciparum, 7 of 35 P. vivax and 48 of 100 negative samples replaced (new) in round 5.
Figure 2: Network of specimen collection, characterization and testing sites
Countries or areas where malaria transmission occursCountries or areas with limited risk of malaria transmissionNo malaria
Malaria, countries or areas at risk of transmission, 2009
This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity.Source: © WHO 2010. All rights reserved.
Collection and testing siteSpecimen characterization
Global specimen bank
QIMR
UCADKEMRIEHNRIEHNRI
CDC
HTD
CIDEIM
IMT IHRDCIPM
DRMIPCIPBIPB
RITM
UL
CDC, Centers for Disease Control and Prevention (Atlanta, United States of America); CIDEIM, Centro Internacional de Entrenamiento y Investigaciones Médicas (Cali, Colombia); DMR, Experimental Medicine Research Division (Department of Medical Research, Yangon, Myanmar); EHNRI, Ethiopian Health and Nutrition Research Institute (Addis Ababa, Ethiopia); HTD, Hospital for Tropical Diseases (London, United Kingdom); IHRDC, Ifakara Health Research and Development Center (Bagamoyo, United Republic of Tanzania); IMT, Instituto de Medicina Tropical (Universidad Peruana Cayetano Heredia, Lima, Peru); IPB, Institut Pasteur de Bangui (Bangui, Central African Republic); IPC, Institut Pasteur du Cambodge (Phnom Penh, Cambodia); IPM, Institut Pasteur de Madagascar (Antananarivo, Madagascar); KEMRI, Kenya Medical Research Institute (Kisumu, Kenya); QIMR, Queensland Institute of Medical Research (Brisbane, Australia); RITM, Research Institute of Tropical Medicine (Manila, Philippines); UCAD, Université Cheikh Anta DIOP (Dakar, Senegal); UL, University of Lagos (Lagos, Nigeria).
2524 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
4. objectiVe
The objective of the programme is to evaluate malaria RDTs for performance to guide procurement of RDTs for use in the field in malaria-endemic countries.
5. Materials and MetHods
5.1. test selection In August 2012, the WHO-FIND malaria RDT evaluation programme issued a call for expressions of interest to manufacturers of malaria RDTs with information on the requirements for submission of a product to round 5 and the conditions for participation in the evaluation programme (26). Manufacturers of products that had not been retested since round 1 were informed of a new requirement to resubmit products within less than 5 years or to have these products and their performance characteristics removed from the summary results document, which is a compilation of the results of all previous rounds of testing. Other standard requirements included valid ISO 13485:2003 certification from all manufacturing sites, a supply of sufficient quantities
of products (1100 tests from each of two lots),1 compliance with the product definition2 and deadlines for document submission.
Thirty-nine manufacturers, proposing 99 products, responded to the call. In order to keep to the schedule and budget and to accommodate 10 compulsory product resubmissions, manufacturers were asked to limit their voluntary submis-sions to one product. Finally, 42 products were tested in round 5 (Table 1a). Catalogue numbers and verification with
1 Manufacturers were requested to supply an additional 500 RDTs per lot voluntarily to support the WHO-FIND evaluation of malaria recombinant antigens.
2 A working definition of a product can be found in Annex 2 (http://www2.wpro.who.int/NR/rdonlyres/EEF2F4B0-5863-438A-8442-8F8CC1AA7F8B/0/EOIAnnex1_2_3_Round5_version21.docx, accessed 23 May 2014).
Table 1a: Manufacturers and products accepted into round 5 of WHO malaria RDT product testing Programme
Manufacturer Product name Catalogue numbera Target antigens
Access Bio. Inc.
CareStart™ Malaria pLDH (PAN)b G0111/G0111-ET pan-pLDH —
CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combob G0131/G0131-ET pan-pLDH HRP2
CareStart™ Malaria HRP2 (Pf)b G0141/G0141-ET HRP2 —
Advy Chemical Pvt. Ltd. (Affiliate of Bharat Serums & Vaccines Ltd. ) EzDx™ Malaria Pan/Pf Rapid Test Detection Kitd RK MAL 001 pan-pLDH HRP2
Artron Laboratories Inc. Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit A03-18-322 pan-pLDH HRP2
ASAN Pharmaceutical Co., Ltd ASAN Easy Test® Malaria Pf/Pan Ag AM4650-K Pvom-pLDH HRP2
AZOG, INC. Malaria pf-LDH/PAN-LDH Antigen Test Deviced MFV-124 pan-pLDH PfpLDH
Bhat Bio-Tech India (P) Ltd. Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Testd MAT-PF/PAN-50 Pvom-pLDH HRP2
Bio Focus Co., Ltd. BioTracer™ Malaria Pf/PAN Rapid Card 17012 pan-pLDH HRP2
BIOSYNEX IMMUNOQUICK® MALARIA falciparum 0502_K25 HRP2 —
Blue Cross Bio-Medical (Beijing) Co., Ltd. One Step Malaria P.F/P.V Testd 523352 Pv-pLDH HRP2
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2524 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Manufacturer Product name Catalogue numbera Target antigens
CTK Biotech Inc. OnSite Pf/Pan Ag Rapid Testd R0113C HRP2 pan-pLDH
DIALAB GmbH DIAQUICK Malaria P.f/Pan Cassette Z11200CE pan-pLDH HRP2
GenBody Inc. GenBody™ Malaria Pf/Pan Ag MALAG100 pan-pLDH HRP2
Genomix Molecular Diagnostics Pvt. Ltd.
Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device GM006 HRP2 Pv-pLDH
Green Cross Medical Science Corp. (Korea) Genedia® Malaria P.f/Pan Ag Rapid Test 20-0146-01 pan-pLDH HRP2
Guangzhou Wondfo Biotech Co. Ltd. Wondfo® One Step Malaria P.f/P.v Whole Blood Test W056-C Pv-pLDH HRP2
Hangzhou Biotest Biotech Co. Ltd. RightSign™ Malaria P.f./Pan Rapid Test Cassette IMPN-C52 aldolase HRP2
Humasis Co., Ltd. Humasis Malaria Pf/Pan Antigen Testd AMAL-7025 pan-pLDH HRP2
ICT INTERNATIONAL ICT Malaria Dual Testd ML03 HRP2 pan-pLDH
IMACCESS S.A.S Vikia® Malaria Ag Pf/Pan 412499 HRP2 aldolase
InTec Products, Inc.Advanced Quality™ Rapid Malaria Test (Pf/Pan) ITP11005 pan-pLDH HRP2
Advanced Quality™ One Step Malaria Pf Testb ITP11002TC1/TC40 HRP2 —
J. Mitra & Co. Pvt. Ltd.
Advantage Mal Cardb IR221025 pan-pLDH Pf-pLDH
Advantage Malaria Pan + Pf Card IR231025 pan-pLDH HRP2
Advantage Pan Malaria Cardb IR013025 pan-pLDH —
Avantage P.f Malaria Cardb IR016025 HRP2 —
LAB-CARE Diagnostics (India) PVT. LTD. ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test MAGC 25 pan-pLDH HRP2
Medical Diagnostech (Pty) Ltd MD Malaria Pf/Pan-pLDH test MDMALLDH001 HRP2 pan-pLDH
SARL NG Biotech, Z.A. NG-Test MALARIA Pf/Pan (pLDH) NG-MAL-W23-001 HRP2 pan-pLDH
Premier Medical CorporationFirst Response® Malaria Ag P. falciparum (HRP2) Card Testb I13FRC HRP2 —
First Response® Malaria Ag. pLDH/HRP2 Combo Card Testd I16FRC pan-pLDH HRP2
RapiGEN INC. BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C30RHA25 pan-pLDH HRP2
Shanghai Kehua Bio-engineering Co.,Ltd. KHB® Malaria Ag P.f Rapid Test KH-R-06-20 HRP2 —
Span Diagnostics Ltd. ParaHIT®fV Rapid test for P. falciparum and P. vivax Malaria - Device 55IC402-50 Pv-pLDH HRP2
SSA Diagnostics & Biotech Systems diagnosticks-Malaria (Pf) Rapid Diagnostic Testd KMFC6001 HRP2 —
Standard Diagnostics Inc.c SD BIOLINE Malaria Antigen Pfb 05FK50/05FK53 HRP2 —
SD BIOLINE Malaria Antigen Pf/Pand 05FK60 pan-pLDH HRP2
Orgenics Ltd.(IS)c Clearview® Malaria Duald VB20 HRP2 pan-pLDH
Vision Biotech (Pty) Ltdc Vision Malaria Pfd VB01 HRP2 —
Zephyr Biomedicals Parascreen® Rapid test for malaria Pan/Pfd 50310025 pan-pLDH HRP2
Zhejiang Orient Gene Biotech Co., Ltd. Malaria Pf/Pan One Step Rapid Test RT 20222 HRP2 pan-pLDH
Pf, P. falciparum Pv, P. vivax Pvom, P. vivax, ovale, malariae HRP2, histidine-rich protein 2 pLDH, Plasmodium lactate dehydrogenasea The same products may have different catalogue numbers to reflect box sizes, kit contents or site of manufacture. Usually this involves the end portion of the product
code. Please contact manufacturers for details b Indicates products submitted for compulsory retesting in round 5c Alere subsidaries d These products have been submitted voluntarily to previous rounds of WHO malaria RDT product testing (round 1-4). For details on all product resubmissions refer to
Table S1.
Table 1a: (continued)
2726 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Table 1b: Products due for compulsory resubmission in round 5
Manufacturer Product name Catalogue number
Participation in round 5a
Access Bio, Inc.
CareStart™ Malaria pLDH (PAN) G0111 Yes
CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO G0131 Yes
CareStart™ Malaria HRP2 (Pf) G0141 Yes
Acon Laboratories, Inc Malaria Plasmodium falciparum Rapid Test Device (Whole Blood) IMA-402 No
Amgenix International, Inc. OnSight - ParaQuick (Pan, Pf) Test 536-25DB No
BiosynexImmunoquick Malaria Falciparum 0502_K25 Yes
Immunoquick Malaria +4 0506_K25 No
Diagnostics Automation/Cortez Diagnostics Inc. Malaria P.F/Vivax 172110P-25 No
Human GmbHHexagon Malaria 58051 No
Hexagon Malaria Combi 58024 No
IND Diagnostic Inc. One Step Malaria Antigen Strip 820-1 No
Innovatek Medical Inc. Quickstick Malaria Antigen Testb No
Intec Products, Inc. ADVANCED QUALITY TM MALARIA (p.f) POCT ITP11002TC1 Yes
Inverness Medical Innovations, Inc. Binax Now Malaria IN660050 No
J. Mitra & Co. Pvt. Ltd
Advantage P.f. Malaria Card IR016025 Yes
Advantage Pan Malaria Card IR013025 Yes
Advantage Mal Card IR221025 Yes
Premier Medical Corporation Ltd. First Response® Malaria Ag HRP2 II3FRC Yes
Span Diagnostics Parahit-Total Device Rapid Test for P. falciparum and Pan malaria species 25989 No
Standard Diagnostics SD Bioline Malaria Ag Pf 05FK50 Yes
Unimed International FirstSign – Malaria Pf Card Test - No
FirstSign – ParaView-2 (Pv + Pf) Card Test 2102CB-25 No
a The results of the first tests of the products in this list that were not retested in round 5 have been removed from tables S2 and S3 and figs S1 and S2. b Co-listed with IND Diagnostics - One Step Malaria Antigen Strip (820-1)
manufacturers showed that 23 of the 42 products (55%) had been submitted previously to one or more rounds, including 10 (45%) scheduled for compulsory resubmission (Table1b). All the products met the minimum performance requirements1 in the initial evaluation against the P. falciparum culture-derived panel (phase 1) and were therefore evaluated fully.
Of the 42 products that were fully evaluated, 9 are designed to detect P. falciparum alone, 31 to detect and differentiate P. falciparum from non-P. falciparum malaria and from P. falciparum and P. vivax or P. vivax, ovale, malariae, and 2 to detect P. falciparum and non-P. falciparum malaria without distinguishing between them. Annexes 1 and 2 give a comprehensive overview of the product characteristics.
1 PDS > 80% against high-density (2000 parasites/µL) P. falciparum in culture
5.2. the product testing protocol The testing process is outlined in Fig. 3 and in the Methods manual for product testing of malaria rapid diagnostic tests, version 5 (24). In brief, RDTs from each of two lots of each product were evaluated against a panel of parasite-positive and parasite-negative cryopreserved blood samples and a panel of parasite-negative samples. Both lots were also tested for heat (thermal) stability, evaluated after 2 months’ storage at 4 °C, 35 °C and 45 °C. An ease-of-use description was completed in a standard assessment format, and common RDT anomalies were recorded.
The testing and all the results were monitored by the WHO-FIND steering committee, and manufacturers were given 30 days to comment on the results for individual products before publication.
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2726 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
5.3. evaluation panelsRDTs were evaluated against three panels:
• P. falciparum culture lines (includes a subset, “manufac-turer’s panel”) at low (200 parasites/µL) and high parasite density (2000 parasites/µL);
• wild-type Plasmodium species (P. falciparum, P. vivax) from naturally infected humans diluted with parasite-negative samples to low (200 parasites/µL) and high parasite density (2000 or 50001 parasites/µL). All samples are prepared from isolates that express HRP2; and
• a parasite-negative panel (“clean” samples and disease-specific or blood factor-specific samples).
An overview of sample collection and characterization is given in the methods manuals prepared for this purpose (24, 25). Characterization results for each round are available on the WHO/GMP and FIND websites (27). Thus, each panel specimen was characterized for:
• species, by duplicate microscopy (two microscopists) and confirmation of mono-species infection by nested polymerase chain reaction (PCR);
1 Four (4%) of the 100 P. falciparum dilution sample sets contained 200 and 5000 parasites/µL, and two (6%) of the 35 P. vivax dilution sample sets contained 200 and 5000 parasites/µL.
• antigen concentration, by quantitative ELISA for HRP2, pLDH and aldolase; and
• the absence of malaria parasites by nested PCR and confirmatory testing for other diseases in the case of parasite-negative samples.
Most P. falciparum samples in the global specimen bank are also characterized according to HRP2 sequence by PCR amplification and sequencing. This is not performed on samples collected after 2009, as accumulated evidence indicates that HRP2 variation has no significant effect on RDT sensitivity (28). The geographical origin of all samples is recorded.
panel composition
P. falciparum-cultured parasites panel
Twenty culture-adapted strains of P. falciparum from various geographical locations were selected, including 14 strains with type B HRP2 sequence, five with type A and one with type C. All specimens were derived from the CDC culture bank and diluted in O-positive blood from donors in the USA (24).
Wild-type parasite panel
The parasite-positive wild-type (clinical) panel consisted of samples from 100 cases of P. falciparum and 35 cases of P. vivax malaria, from 12 collection sites in Africa, Asia and
Figure 3: Overview of malaria RDT product testing
RDT product testing flow chart
Panel detection scoreand false-positive rate
Heat stability Ease-of-use description
Test RDTs against high and low density samples
of phase 1 panel
Select RDTs from 2 differents lots Blood safety
Place in a 35°C
incubator
Store for 2 months at 75% humidity
Remove and allow RDTs to reach room temperature
Prepare RDTs with a 200 p/µL
sample
Prepare RDTs with a 2000 p/µL
sample
Place in a 45°C
incubator
Initial test (room temperature) 200, 2000 p/µL
Total time to obtain result
Number of timed steps
Quality of the instructions
Additional information• format• blood transfer method• items included in package• language• anomalies
Completedassessment
forms
Proceed to test RDTs against phase 2 panel,
if pass phase 1
In each case, read each result with:
Record results
Record results
Record results
Technician1
Technician2
2928 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
South America (Fig. 2, 4a and 4b). Samples were collected from febrile patients and processed by standardized methods designed to preserve the target antigen concentration (25). After dilution and cryopreservation, the samples were trans-ferred to the global bank (WHO specimen bank) at CDC for further characterization. Sample antigen (HRP2, pLDH, aldolase) concentrations determined by quantitative ELISA are given in Table 3. The results are based on 94 P. falciparum samples for pLDH, 99 P. falciparum samples for HRP2 and aldolase, 34 P. vivax samples for pLDH and 35 P. vivax samples for aldolase. This panel is highly comparable to those of previous rounds (Annex S1).
Negative blood sample panel
The negative panel consisted of 59 “clean” parasite-negative samples from donor-derived blood obtained in banks or from volunteers in non-endemic (USA) and endemic areas (Kenya, the Philippines and Senegal) that had been found to be malaria-negative by microscopy. The panel also contained 42 parasite-negative samples from donors with diseases that might be used in the differential diagnoses of malaria or that contained blood factors known to be common in the community or that could result in false-positive reactions in immunochromatographic tests (Table 2). All negative control samples were confirmed free of Plasmodium parasites by PCR amplification.
Table 2: Characteristics of Plasmodium spp. negative samples
Nature of negative samplea No.
Clean-negativeb 58
Anti-nuclear antibody positive (sera) 13
Anti-mouse antibody positive (plasma) 3
Rheumatoid factor positive (whole blood and sera) 4
Rapid plasma reagin positive (sera) 5
Chagas' disease antibody positive (plasma) 2
Dengue antibody positive (whole blood sera) 4
Leishmaniasis antibody positive (sera) 5
Schistosomiasis antibody positive (whole blood and sera) 6
a Whole blood unless indicated. Sera and plasma samples were reconstituted packed cells
b Healthy volunteers with no known current illness or blood abnormality
Figure 4a: Origin of phase 2 P. falciparum wild-type (clinical) samples (n=100)
Figure 4b: Origin of phase 2 P. vivax wild-type (clinical) samples (n=35)
Nige
ria
Cent
ral
Afric
an R
epub
lic
Unite
d Re
publ
ic
of T
anza
nia
Colo
mbi
a
Peru
Sene
gal
Cam
bodi
a
Mya
nmar
Phili
ppin
es
Keny
a
Ethi
opia
Colo
mbi
a
Peru
Cam
bodi
a
Ethi
opia
No.
of s
ampl
es
No.
of s
ampl
es
35
30
25
20
15
10
5
0 0
5
10
15
20
Table 3: Malaria antigen concentrations (ng/mL) in round 5 wild-type, low parasite density (200 parasites/µL) samples
pLDH HRP2 Aldolase
P. falciparum P. vivax P. falciparum P. falciparum P. vivax
Mean 15.5 16.8 11.7 1.5 8.1
Median 12.2 13.2 7.0 1.1 7.0
Maximum 43.0 47.9 62.5 7.7 15.0
Minimum 0.2 1.6 0.6 0.0 3.2
Standard deviation 11.4 12.6 13.2 1.5 3.3
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2928 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
5.4. rdt registrationReceipt of each shipment of RDTs at the CDC was recorded in a dedicated RDT register. Temperature monitoring devices were offered to manufacturers free of charge to accompany RDT shipments to the CDC. All RDTs were stored at room temperature (≤ 25 °C) immediately, and temperature monitors were labelled with the date of receipt and forwarded for data extraction and analysis, when applicable.
5.5. specimen panel registrationAll panel specimens were assigned unique identification numbers at the collection sites and stored in aliquots of 50 µL at –70 °C until testing. All data pertaining to specimen identification, storage location and characterization are stored in a secure, dedicated database.
5.6. test phasesThe evaluation is divided into two phases. Each lot of RDTs is evaluated independently. Lots 1 and 2 of each product were tested alternately against defined sample sets,1 testing of a set of lot 1 of all products was completed, then a set of lot 2 was tested, until both lots of all products had been tested against all panel samples.
Phase 1. A screening step is used to allow selection of RDTs that meet the minimal quality requirements. Products from two lots were evaluated against a panel of 20 culture-derived P. falciparum samples at high (2000 parasites/µL) and low (200 parasites/µL) parasite density. To progress to the full evaluation (phase 2), a product evaluated in phase 1 must achieve a minimum PDS of 80% against the samples containing 2000 parasites/µL.
Phase 2. Products from two lots are evaluated against a panel of diluted clinical blood samples containing wild-type parasites and a parasite-negative panel, evaluated for heat (thermal) stability and assessed for ease of use.
• Performance assessment: The mixed parasite-positive and parasite-negative panel comprised 100 P. falciparum, 35 P. vivax at two parasite densities (200 parasites/µL and 2000 (or 5000)2 parasites/µL) and 100 parasite-negative controls.
• Heat stability evaluation: Testing of 15 RDTs from each of two lots against a single culture-derived P. falci-parum isolate (Nigeria XII strain, P. falciparum HRP2 sequence type B with a typical antigen concentration) at 200 parasites/µL, five RDTs from each lot against P. falciparum Nigeria XII strain at 2000 parasites/µL,
1 A sample set consists of 13 P. falciparum specimens and five P. vivax specimens at 200 parasites/µL and 2000 parasites/µL and 13 malaria-negative samples.
2 Four (4%) of the 100 P. falciparum dilution samples sets were at 200 and 5000 parasites/µL and two (6%) of the 35 P. vivax dilution sample sets were at 200 and 5000 parasites/µL.
and four RDTs from each lot against a negative sample was performed after RDTs were maintained for 60 days at room temperature (< 25 °C), 35 °C and 45 °C, at 75% humidity.
• Ease-of-use assessment: After technicians had become familiar with the test device, they jointly described its blood safety characteristics, the quality of the instructions, the number of timed steps and the total time to a result, using a standard reference guide (24).
• RDT anomalies: During testing, technicians regularly reported RDT anomalies according to the list below and guided by Fig. AS2.1. When anomalies were noted frequently, a digital photograph of at least one example was obtained.
• red background
• incomplete clearing (of blood in the results window)
• failure to flow (blood and buffer did not run the length of the strip)
• ghost test lines
• patchy, broken test lines
• diffuse lines
• thin lines
• strip misplaced in cassette
• specimen pad not seen in sample window
5.7. performing rapid testsAll RDTs were maintained at room temperature until first use. When applicable, the desiccant was inspected for colour changes, and products were discarded if they were present. RDTs were labelled with sample identification number, dilution and date test was performed. The tests were used according to the manufacturer’s instructions, except that the recom-mended volume of blood was transferred by micro-pipette from the sample tube, and co-packaged blood transfer devices were not used. The result was recorded by a technician at the minimum specified reading time, and a second technician re-read the result within 30 min for internal monitoring and to obtain information for the manufacturer. Technicians were rotated and blinded to sample type and to each other’s results during phase 2. Annexes 1 and 2 give a descriptive, illustrated summary of the test characteristics and steps and a guide to interpretation of results.
3130 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
5.8. interpreting the resultsThe results of control and test lines were recorded as negative or positive by each technician. Each test was read against a standard colour chart and the band intensity graded as 0 (no visible band), 1, 2, 3 or 4. If the control line was recorded as “0” (no visible band) by either technician, the test was recorded as invalid.
Figs 5 and 6 illustrate the testing sequence at low and high parasite density.
Figure 5: Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 200 parasites/μLThe first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.
Product A
c dReading
1Reading
1Reading
2Reading
2
Lot 2
Test 3 Test 4
a bReading
1Reading
1Reading
2Reading
2
Lot 1
Test 1 Test 2
Detected if 4 positive
first readings
Based on the positive results of first test reading (2 tests per lot), the mean band intensity score =a+b+c+d/4 (excluding negative results).
a Second reading results are for internal use only
Figure 6: Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 2000 parasites/μL The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a and b must be positive.
Product A
aReading
1Reading
2
Test 1
Lot 1
bReading
1Reading
2
Test 2
Lot 2
Detected if 2 positive
first readings
Based on positive results of first test reading (2 tests per lot), in each lot, the mean band intensity score =a+b/2
a Second reading results are for internal use only
Me
tHo
ds
3130 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
6. data ManageMent
Receipt of products was hand-recorded in a RDT register at the CDC as per standard operating procedures. Data associated with specimen collection and characterization were recorded first on hard-copy report forms as per the standard operating procedure at the collection sites (Fig. 2), the Hospital of Tropical Diseases (quantitative ELISA results) and the CDC (PCR results) and then entered directly into Excel followed by importation into a specially developed database.
The results of product panel testing and heat stability testing conducted at the CDC were recorded on report forms by
each technician individually, as per the standard operating procedure. The results were entered in duplicate and analysed for discrepancies.
All source documents and electronic records of the study data are maintained in secure storage until the conclusion of the evaluation, data analysis and publication of the report.
Individual product testing reports were sent to manufacturers on 14 March 2014 for a 30-day review period before publica-tion of the final report. Raw data were made available to manufacturers upon request.
7. QUalitY assUrance
Product testing follows standard operating procedures developed during previous testing, which are based on recom-mendations by expert consultants, with minor modifications by the Steering Committee before round 5 (24). In particular, alternate testing of lots 1 and 2 on discrete sample sets, instead of sequential testing, was introduced, as was a standardized set of descriptions and terms for recording RDT anomalies. Overall, the quality of critical steps was controlled as described below.
7.1. Quality of malaria RDTs and their use
All RDTs were stored in a controlled environment at room temperature (≤ 25 °C). The pouch was opened, and, if applicable, the desiccant was checked for colour change immediately before use. The manufacturer’s instructions were followed, except for use of the blood transfer device provided by the manufacturer: a micropipette was used to ensure the correct blood volume.
A temperature monitoring device was offered to manufac-turers to be shipped with the RDTs to the testing site (CDC). Logs were analysed for temperatures above or below the manufacturer’s recommended storage conditions.
7.2. Quality and objectivity of the RDT reading results
The results were read under good lighting by trained techni-cians tested for visual acuity and doubly entered into the database. Technicians were rotated. The readings of a second
technician were used for internal monitoring. The summarized results were reviewed in detail, and potential discrepancies were identified and cross-checked against source laboratory report forms.
All wild-type parasite samples used in phase 2 were rand-omized with parasite-negative samples and re-labelled for blinded reading of the RDT results.
7.3. Quality of WHO specimen bank samples
Standard operating procedures were established for the preparation of all specimen bank samples (25). Culture lines of parasites and wild-type samples were selected on the basis of previous evidence and data from specific studies. All diluted parasite samples were stored and transported at –70 °C and were used only once within 8 h of thawing.
7.4. Quality of the product testing site
The Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, is the main operating component of the Department of Health and Human Services of the USA, which deals with malaria control and prevention. Laboratories within the Division are accredited by Clinical Laboratory Improvement Amendments and are monitored by an internal quality management system.
3332 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
8. etHical considerations
Each specimen collection site obtained approval from a WHO research ethics review committee and/or a local institutional review board for specimen collection, transport and archiving
of blood samples for the purpose of product testing, lot testing and quality assurance.
9. data analYsis
9.1. Measures of parasite detection: panel detection score and positivity ratesAs shown in Figure 5, a product must return four positive test results at the manufacturers’ recommended minimum reading time (two from lot 1, two from lot 2 at the initial reading time) when tested against a parasite density of 200 parasites/µL to contribute to its PDS. When tested against 2000 or 5000 parasites/µL (Fig. 6), the product must return two positive tests at the manufacturers’ recom-mended minimum reading time (one from each lot). Thus, the PDS is a measure of inter-test and inter-lot consistency, as well as the ability of the test to detect antigen. The PDS for P. falciparum indicates an RDT result that confirms the presence of P. falciparum when tested against cultured and wild-type P. falciparum samples, while the P. vivax PDS indicates Plasmodium-positive/P. falciparum-negative results when tested with wild-type P. vivax samples.
The positivity rate is the percentage of all tests of a particular product that returned a positive result at the manufacturers’
recommended minimum reading time when tested against a P. falciparum or P. vivax sample.
9.2. false-positive resultsFalse-positive results are analysed and reported as two groups: those with incorrect species identification and those that returned a positive result for samples that do not contain Plasmodium spp. Specifically, the false-positive rate is the percentage of all tests of a particular product that returned a positive test result when it should not have, in results obtained at the manufacturer’s recommended minimum reading time.
9.2.1 incorrect species identificationA test is considered to have returned an incorrect species result if a positive P. falciparum test line appears when testing a sample containing non-P. falciparum (P. vivax) parasites. Fig. 7 illustrates the various possibilities for incor-rect species identification in combination tests. For example, if P. falciparum samples result in only a visible pan-specific (or non-P. falciparum-specific) test line in combination
Figure 7: Classification of incorrect species identification with combination malaria RDTs
Pf/pan combination tests
Panel sample Pf + / Pan - Pf + / Pan + Pf - / Pan + Pf - / Pan -
Pf False-positive (non-Pf) Negative
Pv False-positive (Pf)
False-positive (Pf) Negative
Pf/Pv combination tests
Panel Pf + / Pv - Pf + / Pv + Pf - / Pv + Pf - / Pv -
Pf False-positive (non-Pf) Negative
Pv False-positive (Pf)
False-positive (Pf) Negative
Re
sult
s
3332 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
tests, the result is considered to be a false-positive for non-P. falciparum parasites.
9.2.2 false-positive results for Plasmodium-negative samplesAny positive reading of samples with no Plasmodium parasites is considered a false positive. In phase 2, parasite-negative samples are clean-negative samples and samples containing other infectious agents (e.g. dengue, leishmania, Chagas) and immunological factors (e.g. rheumatoid factor, anti-nuclear antibodies, anti-mouse antibodies) (Table 2).
9.3. band intensityAll positive test results were recorded with their band inten-sity against a standard reference chart, matched closely to line colour. On the basis of the results of the first reader, the distribution of band intensity results is presented as the mean band intensity of positive results. In addition, the intensity was expressed for each possible result (0, 1, 2, 3 or 4) as the percentage recorded at that level.1
9.4. lot agreement Agreement between test lots is calculated from the number of samples that return a positive result on both RDTs tested in that lot against parasite-positive samples at 200 parasites/µL, and on the single RDT from each lot tested against samples at 2000 (or 5000) parasites/µL. High inter-lot agreement indicates consistency in detecting malaria parasites. When one test is invalid and the other positive, positive agreement is recorded. Fig. 8 shows sample calculations for lot agreement.
1 A standard intensity comparison chart is used, which allows matching to the closest of four common colour variants of labelled antibodies used in RDTs, each at four levels of intensity.
9.5. invalid testsInvalid tests are those deemed invalid during testing of both lots, with samples at 200 parasites/µL and 2000 (or 5000) parasites/µL.
9.6. Heat (thermal) stability The results of heat stability testing are reported as the number of positive tests against one cultured P. falciparum parasite sample at 200 and 2000 parasites/µL based on the first reading of two lots at each parasite density (maximum score, 30 against 200 parasites/µL samples and 10 against 2000 parasites/µL samples)2 and mean band intensity (for positive tests only based on the first reading) after the lots were stored at room temperature (< 25 °C) and at 35 °C and 45 °C for 2 months.
2 Fifteen tests per lot against 200 parasites/µL samples and 5 tests per lot against 2000 parasites/µL samples. Invalid results were excluded from analysis.
Figure 8: Explanation of lot agreement calculation Test results
(1= positive, 0 = negative)Derived values
(1= both positive, 0 = both negative)
Lot 1 Lot 2 (a) (b) (d) (f)
Test 1reader 1
Test 2reader 1
Test 1reader 1
Test 2reader 1 Lot 1 tests Lot 2 tests Comparison
of lot resultsContribution to
overall
Sample 1 1 1 1 1 1 1 1 1Sample 2 1 0 0 0 Disagree 0 Can’t compare 0Sample 3 0 1 0 1 Disagree Disagree Can’t compare 0Sample 4 0 0 0 0 0 0 0 0Sample 5 1 1 1 1 1 1 1 1
PDS = sum (f) / number of samples = 2/5 = 40Lot 1 PDS = sum (a) / number of samples = 2 / 5 = 40Lot 2 PDS = sum (b) / number of samples = 2 / 5 = 40 Positivity = number of positive results / total number of tests = 11 / 20 = 55%
Agreement between tests = (count number of 0 and 1s in (a) and (b)) / (number of samples x 2 lots) = 7 / 10 = 70% Agreement between lots = (count number of 0 and 1s in (d)) / (number of samples - ‐ number of “can’t compare” in (d)) = 3 /3 = 100%
Note: reader 1 = Technician 1 in raw data files
3534 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
10. relation betWeen parasite densitY and antigen concentration
Malaria RDTs detect parasite-derived antigen. The relation of the concentration of antigen available from the blood sample (after lysis of red cells and parasites) to the peripheral parasite density varies widely because of a series of host and parasite factors (Box 4).
In establishing panels for the product testing programme that reflect possible variation in antigen concentration for parasitaemia of 200 parasites/µL, a large number (> 300) of wild-type parasite samples from clinical cases in different geographical areas were analysed by quantitative ELISA
for HRP2, pLDH and aldolase. Only samples with antigen values within the 90th percentile for HRP, pLDH and aldolase were selected for the performance panels. Furthermore, the distribution of antigen levels for HRP2, pLDH and aldolase was compared with that in previous rounds to ensure consistency. No statistically significant differences in median antigen levels between the panels for rounds 1–5 were detected for any of the three antigens (p > 0.1, Kruskal-Wallis test). Therefore, the panels used for the product testing rounds can be considered comparable (Annex S1).
11. laboratorY VersUs field-based Malaria rdt eValUations
Despite the strengths of the product testing programme, the evaluations are not completely analogous to field testing of malaria RDTs. In order to compose a panel that could be used to evaluate RDTs reproducibly, blood samples must be diluted, frozen and stored below −70 °C; however, blood that has undergone freezing and thawing is lysed and may not have exactly the same characteristics as fresh blood. Another difference from field evaluation is use of a micro-pipette to place blood in the RDT device rather than the blood transfer device provided by the manufacturer. This is necessary because blood is collected from a cryo-tube rather than a finger-prick, and the blood transfer devices provided with the different products vary (30). This technique also ensures the consistency of testing by reducing the likelihood of operator error. As all samples in the panel used for the evaluation are prepared from parasites that express HRP2, the results will not be predictive of field trial results of parasite populations with significant levels of HRP2 deletion (10, 11).
In addition, the population frequency of blood immuno-logical factors or infectious diseases, which can result in false-positive results, may vary. Therefore, the sensitivity
and specificity of an RDT in the field depends on the epide-miological situation. The evaluation reported here does not predict sensitivity or specificity in a given field situation but the rates of detection of target antigens and false-positive results of RDTs against a standardized panel in a controlled, repeatable manner. As the panel is meant to be a close approximation of field samples, the detection rates of different products will be reflected in similar differences in the field. The panel is designed to include a large number of samples that are close to the limit of detection of RDTs (200 parasites/µL) and is therefore likely to discriminate between them more clearly than a field trial. It follows that in settings where parasite density is very high, no differences in the PDS and positivity rates of tests or much smaller differences will be observed compared to those reported against the WHO evaluation panel. Furthermore, where the parasite density is very low, the detection rates may be lower than those reported here.
Field trials have a place in product selection, particularly in determining which of a short-list of products is most appropriate for the technicians and situation of its intended
Box 4. Explanations for variable antigen concentrations in samples with the same parasite density
• variationinantigenexpressionamongisolates
• differentdurationsofinfections(accumulatingantigens)
• differentparasitegrowthstagesatthetimeofcollection(expressingdifferentlevelsofantigens)
• presenceofcirculatingHRP2frompreviouscyclesofgrowth
• HRP2producedbyparasitessequesteredinthehost’svasculartissuesthatcannotbeaccountedforintheestimateofparasitedensity on the blood slide (29)
Re
sult
s
3534 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
use in a programme (e.g. ease-of-use characteristics). Such trials should have carefully defined objectives and procedures designed to achieve them. Trials to determine the probable field sensitivity and specificity of a product also have a place but require large samples and populations with low parasite densities if significant differences are to be found
between well-performing products; they must also be closely controlled and are therefore expensive. Such trials do not allow comparison of a large number of products. WHO has published recommendations for good practice in malaria field trials (31), which should be followed to improve the reproducibility and quality of the results.
12. resUlts
12.1. summaryRound 5 of WHO malaria RDT product testing provided results for 42 products evaluated against P. falciparum culture samples, and all the products proceeded to evaluation against wild-type samples collected from parasitaemic patients on three continents and a large panel of parasite-negative samples. Heat stability was assessed at the temperatures commonly encountered in malaria-endemic countries. Thirteen research institutes were engaged in either sample collection or sample characterization to establish the evalu-ation panels. Between January 2013 and December 2013, approximately 58 400 RDTs were tested at the CDC.
The main results are presented in Tables 4 and 5, which group the RDTs by the species they are designed to detect, i.e. P. falciparum only, P. falciparum and non-falciparum species, P. falciparum and P. vivax, P. vivax, ovale and malariae, pan only or all malaria species without discrimination. Note that only tests against P. falciparum and P. vivax samples were evaluated, and the evaluation does not therefore indicate whether a product intended to detect other species can do so.
PDS at both high and low parasite concentrations are presented, as are false-positive rates and the percentage of invalid test results. Tests in each category are listed alphabetically, but the results are colour-coded according to WHO-recommended RDT procurement selection criteria (Box 3). When choosing an appropriate product, it is important also to review its thermal stability (Table 6) in the context of the expected conditions of transport and storage in the field.
The results of the evaluation are listed below.
• The overall range of results against wild-type and negative samples, including PDS, positivity rate, false-positive rate and heat stability, were similar to those reported in rounds 1–4 (3–6). The median PDS for P. falciparum was slightly lower at low parasite densities than in the previous round (89.3% vs 85%), and no products scored a PDS of 100% in round 5. The PDS for P. vivax at low densities has improved consistently since round 1 (median, 30%), the results for rounds 2, 3, 4 and 5 being 75.0%, 51.4%, 61.8%
and 65.7% respectively. The median false-positive rate remained consistently at about 1%; however, the range of false-positive rates increased significantly with each round of testing (upper limit in rounds 1–5: 28%, 37%, 44%, 99.1% and 81.3%). Some products with high false-positive rates also had high PDS, underscoring the importance of reviewing all aspects of product performance.
• A number of RDTs consistently detected malaria at a low parasite density (200 parasites/µL), had low false-positive rates, were stable at tropical temperatures, are relatively easy to use and can detect P. falciparum, P. vivax or both infections, increasing the number of available well-performing tests from that in rounds 1–4.
• The performance of products varied widely at low para-site density (200 parasites/µL), but most showed a high detection rate for P. falciparum and P. vivax at 2000 (or 5000) parasites/µL.
• P. falciparum tests targeting the HRP2 antigen had the highest PDS for P. falciparum, and the two products with the poorest performance at 200 parasites/µL targeted P. falciparum-specific pLDH antigen. Two resubmitted pan-only tests maintained good PDS for P. falciparum at low parasite density.
• Several combination tests achieved PDS at the upper end of the range for both P. falciparum and P. vivax. (Fig. S3).
• The test performance of some products varied between lots.
• Most combination tests in which HRP2 is used for detec-tion of Pf return positive results predominantly only on the HRP2 band at lower densities of Pf. This reinforces manufacturers instructions to classify Pf infections as either HRP2 test line-positive alone or in combination with the pan-pLDH line.
Tables 4 and 5 summarize the performance of malaria RDTs against cultured P. falciparum parasites, blood containing wild-type P. falciparum and P. vivax parasites and Plasmodium spp.-negative samples. Detailed phase-1 and phase-2 results of product testing are given in annexes 3 and 4, respectively. The data are shown graphically in Figs 9–27.
3736 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
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Re
sult
s
3736 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Pane
l det
ectio
n sc
orea
(n=2
0)Fa
lse-p
ositi
ve n
on-P
f in
fect
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Inva
lid r
ate
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60)
200
pa
rasit
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L20
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para
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200
para
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0)20
00 p
aras
ites/
μL
(n=4
0)
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um a
nd P.
viv
ax M
alar
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Devi
ce55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
95.0
100.
01.
30.
00.
0W
ondf
o® O
ne S
tep
Mal
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Who
le B
lood
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dfo
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td.
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52.
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n on
lyAd
vant
age
Pan
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dIR
0130
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a &
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Pvt
. Ltd
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Pvo
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sam
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dere
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nly
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l RDT
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oth
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an, a
t min
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re p
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ly p
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infe
ctio
n
Tabl
e 4
(con
tinue
d)
3938 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e 5:
Sum
mar
y ph
ase-
2 pe
rfor
man
ce o
f 42
mal
aria
RDT
s ag
ains
t w
ild-t
ype
(clin
ical
) P.
falc
ipar
um a
nd P
. viv
ax s
ampl
es a
t lo
w (2
00)
and
high
(200
0a)
para
site
den
sity
(pa
rasi
tes/
μL)
an
d Pl
asm
odiu
m s
pp. n
egat
ive
sam
ples
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l det
ectio
n sc
oreb
False
-pos
itive
rat
es (%
)To
tal f
alse
-po
sitiv
e ra
tese
(%)
Inva
lid
rate
(%)
(n=1
214)
200
para
sites
/μL
2000
par
asite
s/μL
200
para
sites
/μL
2000
par
asite
s/μL
Clea
n-ne
gativ
e sa
mpl
es
Pf s
ampl
es
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00)
Pv s
ampl
es
(n=3
5)Pf
sam
ples
(n
=100
)Pv
sam
ples
(n
=35)
Pf s
ampl
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sam
ples
Pf s
ampl
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ples
Fals
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sitiv
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n-Pf
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fect
ionc
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=400
)
Fals
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sitiv
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fect
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(n
=140
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Fals
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sitiv
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n-Pf
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fect
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=200
)
Fals
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sitiv
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fect
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=70)
False
-pos
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asm
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m
spp.
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ctio
n (n
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Pf o
nly
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nced
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p M
alar
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33)
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ntag
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f Mal
aria
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a &
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reSt
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stic
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asse
tte
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35)
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t Res
pons
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alar
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UN
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falc
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34)
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KHB®
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apid
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tKH
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6-20
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angh
ai K
ehua
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-eng
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ring
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td.
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10.6
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BIO
LIN
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alar
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ntig
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on B
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ch (P
ty) L
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5.1
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and
pan
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CARE
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EP M
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f/Pa
n An
tigen
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tM
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B-CA
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dia)
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0 (1
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4Ad
vanc
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34)
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48.
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31)
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al C
ard
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o. P
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td.
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0.7
0.5
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ard
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cus
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cess
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70.
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00.
40.
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® M
alar
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89.0
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0.3
12.1
0.5
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filia
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nes
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Re
sult
s
3938 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l det
ectio
n sc
oreb
False
-pos
itive
rat
es (%
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tal f
alse
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sitiv
e ra
tese
(%)
Inva
lid
rate
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214)
200
para
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s/μL
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para
sites
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n-ne
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mpl
es
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ampl
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00)
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ampl
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ples
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sam
ples
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Pf s
ampl
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ples
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ampl
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sam
ples
Fals
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sitiv
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fect
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=400
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Fals
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sitiv
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fect
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sitiv
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fect
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Fals
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sitiv
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in
fect
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(n
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False
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m
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ctio
n (n
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SD B
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harm
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p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.87
.028
.698
.097
.11.
5 (3
99)
2.9
1.5
2.9
2.1
0.1
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
77.0
100.
098
.010
0.0
NA
NA
NA
NA
0.4
0.0
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
84.0
88.6
99.0
97.1
NA
NA
NA
NA
0.0
0.0
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
a 4
(4%
) of t
he 1
00 P
. fal
cipa
rum
dilu
tion
sam
ple
sets
had
200
and
500
0 pa
rasi
tes/
μL a
nd 2
(6%
) of t
he 3
5 P.
viv
ax d
ilutio
n sa
mpl
e se
ts h
ad 2
00 a
nd 5
000
para
site
s/μL
b A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
vec
For c
ombi
natio
n te
sts,
pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e-po
sitiv
e no
n P.
falc
ipar
um in
fect
ion
d Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
ion
e Th
e to
tal n
umbe
r of t
imes
a p
ositi
ve re
sult
for m
alar
ia w
as g
ener
ated
whe
n it
shou
ld n
ot h
ave
been
Perf
orm
ance
mea
sure
Reco
mm
ende
d W
HO
pr
ocur
emen
t cr
iteria
Pa
nel d
etec
tion
scor
e fo
r Pf a
nd P
v 20
0/µL
sam
ples
≥ 75
%
Fals
e-po
sitiv
e ra
tes
agai
nst c
lean
-neg
ativ
es
< 10
%
Inva
lid ra
te<
5% o
f tes
ts c
ondu
cted
Tabl
e 5
(con
tinue
d)
4140 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
12.2. phase 1: P. falciparum culture panelAll the tests consistently detected ≥ 95% of cultured P. falciparum parasites at high parasite density (2000 or 5000 parasites/µL); however, the PDS was highly variable (0–100%) at low parasite density (200 parasites/µL). At low parasite density, the products with the highest PDS targeted HRP2 (Fig. 9).
Figure 9: Phase-1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/μL) according to target antigen type (HRP2 or pLDH)
200 (HRP2)
200 (pLDH)
2000 (HRP2)
2000 (pLDH)
Pan
el d
etec
tion
sco
rea
a A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
Re
sult
s
4140 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
12.3. phase 2: Wild-type P. falciparum and P. vivax and Plasmodium spp.-negative samples 12.3.1 P. falciparum detectionAll 42 products in round 5 were designed to detect P. falci-parum. As in phase 1, most of the tests (34; 81%) had a PDS ≥ 95% of P. falciparum samples at high parasite densities. Seven of the nine products specific for P. falciparum alone achieved a PDS ≥ 75% against samples with low parasite density (Fig. 10).
Figure 10: Phase-2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000a) parasite density (parasites/μL) according to target antigen type (HRP2 or pLDH)b
Pan
el d
etec
tion
sco
rec
200 (HRP2)
200 (pLDH)
2000 (HRP2)
2000 (pLDH)
a 4 (4%) of the 100 P. falciparum dilution samples sets had 200 and 5000 parasites/μL and 2 (6%) of the 35 P. vivax dilution sample sets had 200 and 5000 parasites/μL.
b Phase-2 evaluation panel consisted of 100 clinical blood samples containing wild-type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000 p/μL.
c A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
4342 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
12.3.2 P. vivax detection Fig. 11 shows that 31 of 33 (94%) products designed to detect P. vivax consistently detected ≥ 75% at high parasite density (2000 or 5000 parasites/µL), and 14 (42%) achieved the same threshold of PDS against samples with 200 parasite/µL. The overall detection rate in low parasite density wild-type P. vivax samples was lower than that for P. falciparum. At a low parasite density (200 parasite/µL), only 8 products had a PDS ≥ 90%, and 19 had a PDS < 75% (Table 5).
12.3.3 combined detection of P. falciparum and P. vivax Of the 33 pan-specific and combination tests, 13 (39%) had a PDS ≥ 75% for both P. falciparum and P. vivax at a low parasite density (200 parasites/µL) (Table 5). These included the two pan-specific only tests. Several performed well at a high parasite density.
Figure 11: Phase-2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000a) parasite density (parasites/μL) according to target antigen type (aldolase, pLDH)b
Pan
el d
etec
tion
sco
rec
2000 (pLDH)
200 (pLDH)
2000 (aldolase)
200 (aldolase)
a 2 (6%) of the 35 P. vivax dilution sample sets had 200 and 5000 parasites/μL. b Phase-2 evaluation panel consisted of 35 clinical blood samples containing wild-type P. vivax; RDTs performed = 2 tests x 2 lots at 200 p/μL
and 1 test x 2 lots at 2000 p/μL. c A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
Re
sult
s
4342 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
12.3.4 P. falciparum and P. vivax positivity rate The positivity rate was measured in addition to the PDS, to measure the number of times a test returned a positive result. As expected, the positivity rates were higher than the PDS but mirrored the PDS against wild-type P. falciparum and P. vivax samples (Figs 12 and 13).
12.3.5 band intensity Although RDTs do not provide quantitative results, the techni-cians graded positive results according to a standard colour chart and calculated the mean band intensity for positive results (Annex 4, tables A4.2 and A4.3). A positive correlation was found between the PDS and band intensity (Spearman rank correlation, r = 0.67, p < 0.001 for the P. falciparum panel and r = 0.66, p < 0.001 for the P. vivax panel).
Figure 12: Phase-2 P. falciparum panel detection score and positivity rate at 200 parasites/μLa
Pan
el d
etec
tion
sco
reb/P
osi
tivity
rat
ec (%
)
Positivity rate (HRP2)
Positivity rate (pLDH)
Panel detection score (HRP2)
Panel detection score (pLDH)
a Phase-2 evaluation panel consisted of 100 clinical blood samples containing wild-type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000 p/μL.
b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.c The total number of times a test returned a positive result divided by the total number of times it should have (x 100).
4544 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Of the combination RDT products containing a pan test band that gave a positive indication for P. falciparum against low-density P. falciparum samples, 44.1% (3850/8721) gave positive results on both the P. falciparum and pan test bands, and 55.9% (4871/8821) were positive only on the P. falciparum test band. Of HRP2-detecting products, 41.9% (3454/8247) of those that detected P. falciparum showed both the P. falci-parum (HRP2) and the pan test band (pan-pLDH) as positive, while 58.1% (4793/8247) were positive only on the P. falci-parum HRP2 test band. The values were 83.5% (396/474) and 16.5% (78/474) for the non-HRP2-based products.
When the pan test band in the combination products was positive, the mean intensity of the band was 1.07 (standard deviation, 0.23), which was significantly lower than the corresponding mean P. falciparum test band intensity (mean, 2.04; standard deviation, 0.42), when tested against the lower-density P. falciparum parasite panel (paired t test, p < 0.001). There was no correlation between the mean intensity of the pan test band and the P. falciparum test band (r = –0.049, p = 0.805).
Figure 13: Phase-2 P. vivax panel detection score and positivity rate at 200 parasites/μLa
Pan
el d
etec
tion
sco
reb/P
osi
tivity
rat
ec (%
)
Positivity rate (pDLH)
Positivity rate (aldolase)
Panel detection score (pLDH)
Panel detection score (aldolase)
a Phase-2 evaluation panel consisted of 35 clinical blood samples containing wild-type P. vivax; . RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000 p/μL.
b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. c The total number of times a test returned a positive result divided by the total number of times it should have (x 100).
Re
sult
s
4544 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
12.3.6 false-positive rates Eight (19%) tests had false-positive rates > 10% on 59 clean-negative samples on any test line (Figs 14 and 15). The same eight tests also had high false-positive rates for samples containing other pathogens and immunological abnormalities.
Only one test with a low false-positive rate (< 10%) on clean-negative samples returned high false-positive rates (range, 8.3–100%) against samples from patients with other blood pathogens. Several tests with low false-positive rates (< 10%) on clean-negative samples had high false-positive rates against samples with immunological blood abnormalities,
Figure 14: Phase-2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samplesa
Fal
se-p
osi
tive
rate
(%)
HRP2
pLDH
a Phase-2 evaluation panel consisted of 100 Plasmodium spp.-negative samples, of which 59 were clean negatives from healthy volunteers with no known current illness or blood abnormality.
4746 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 15: Phase-2 Plasmodium spp. (pan or P. vivax/Pvom test line) false-positive rate against clean-negativesa
Fal
se-p
osi
tive
rate
(%)
Aldolase
pLDH
a Phase-2 evaluation panel consisted of 100 Plasmodium spp.-negative samples, of which 59 were clean negatives from healthy volunteers with no known current illness or blood abnormality.
particularly those containing rheumatoid factor and human anti-mouse antibody. There were, however, only 13 samples containing non-Plasmodium infectious agents and 29 samples containing immunological factors. For detailed information on the blood abnormalities and pathogens that generated false-positive results in specific products, see Annex 4 (tables A4.8 and A4.9).
Importantly, there was no clear trend of higher false-positive rates in tests with higher PDS, indicating no clear trade-off between the sensitivity and specificity of the tests at these detection thresholds (Figs 16 and 17).
Re
sult
s
4746 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 16: Phase-2 P. falciparum false-positive ratea versus P. falciparum panel detection score (PDS)b at low (200) parasite density (parasites/μL)
Fal
se-p
osi
tive
rate
(%)
P. falciparum PDS at 200 parasites/µLa False-positive rate is for clean-negatives only. b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
Figure 17: Phase-2 P. vivax false-positive ratea versus P. vivax panel detection scoreb at low (200) parasite density (parasites/μL)
Fal
se-p
osi
tive
rate
(%)
P. vivax PDS at 200 parasites/μL
Aldolase
pLDH
a False-positive rate is for clean-negatives only. b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
4948 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
12.4. performance of products under the compulsory resubmission requirementWith the new requirement for compulsory resubmission of products within 5 years of testing and the limit of one voluntary submission per manufacturer, over half (55%) of the products in round 5 had been evaluated previously. For 17 (74%) of the resubmissions, this was the second testing, and six had been tested more than twice. Figs 18 and 19 show the performance in first and second testing of products against wild-type P. falciparum and P. vivax at 200 parasites/µL and clean-negative samples that had been resubmitted compulsorily and voluntarily.
For the 10 products that had not been tested since round 1 (compulsory resubmissions), a significant correlation was found between the PDS in rounds 1 and 5 for P. falciparum at low density (Spearman rank correlation, r = 0.92, p < 0.001). The median change in PDS between the two rounds was –7.6% (range, –32.0 to 4.8%), which was significantly different from zero (Wilcoxon signed rank test, p = 0.013). As only four of the products detect non-falciparum parasites, no statistical analysis was conducted for detection of the P. vivax parasite panel.
The change in performance between rounds followed a different pattern for the 13 products that were voluntarily resubmitted for testing. No significant correlation was found in the PDS for P. falciparum at lower parasite density in
Figure 18: Phase-2 P. falciparum panel detection scorea at low (200) parasite density (parasites/μL) during initial and subsequenttestingofcompulsorilyandvoluntarilyresubmittedmalariaRDTs
Panel detection score (prior submission)Panel detection score (round 5)False-positive (prior submission)False-positive (round 5)
Pan
el d
etec
tion
sco
rea
Compulsory retest Voluntary retest
Fal
se-p
osi
tive
Pla
smo
diu
m s
pp
. rat
e o
n cl
ean-
neg
ativ
e sa
mp
lesb
(%)
a Panel detection score: A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative, blood samples from healthy volunteers with no known current illness or blood abnormality.
Re
sult
s
4948 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
consecutive submissions (Spearman rank correlation, r = 0.32, p = 0.29). The median change in detection of P. falciparum was 6.5% (range, –10.0 to 42.0%), which was significantly different from zero (Wilcoxon signed rank test, p = 0.033). Most of these products (11/13) detected P. vivax, and detec-tion of this parasite improved overall (median change, 10.6%; range, –20.0 to 100.0%), although the change was not statistically significant (Wilcoxon signed rank test, p = 0.075). No correlation was found in the PDS against P. vivax at a lower parasite density of consecutive submissions (Spearman rank correlation, r = –0.032, p = 0.925).
Importantly, there was little change in the false-positive rates of the resubmitted products, with four exceptions. The high false-positive rates (> 25%) of two voluntarily resubmitted products in prior testing were reduced to < 5% in round 5, while their ability to detect P. vivax was improved, with minimal loss of ability to detect P. falciparum. The opposite result was found for another two voluntarily submitted products with low false-positive rates (< 2%) in prior testing, which returned exceptionally high false-positive rates (> 75%) in round 5. These changes were associated with a higher PDS for P. falciparum at a lower density and mixed results for P. vivax detection.
Figure 19: Phase-2 P. vivax panel detection scorea at low (200) parasite density (parasites/μL) during initial and subsequenttestingofcompulsorilyandvoluntarilyresubmittedmalariaRDTs
Panel detection score (prior submission)Panel detection score (round 5)False-positive (prior submission)False-positive (round 5)
Pan
el d
etec
tion
sco
rea
Compulsory retest Voluntary retest
Fal
se-p
osi
tive
Pla
smo
diu
m s
pp
. rat
e o
n cl
ean-
neg
ativ
e sa
mp
lesb
(%)
a Panel detection score: A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative, blood samples from healthy volunteers with no known current illness or blood abnormality.
5150 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
13. Heat stabilitY
A single P. falciparum culture sample (from the same lot as tested in rounds 3 and 4) was used as the reference sample to test heat stability. This was necessary because establishment of a continuous in vitro culture system for P. vivax is very difficult, largely because of the selective invasion of reticulocytes by the parasite. Therefore, it is not possible to provide stability data on test lines that detect only non-P. falciparum parasites. Such data, and confirmatory data on the stability of recent production lots of all tests, should be obtained from manufacturers and through the WHO-FIND lot-testing programme during product selection for procurement of RDTs.
All the P. falciparum-only RDT test lines were heat-stable. Thus, they detected a cultured P. falciparum sample the same number of times when stored at room temperature (< 25 °C) or at 35 °C or 45 °C (75% humidity) for 2 months (Fig. 20).
Overall, the products were more stable against samples with high (2000 parasites/µL) rather than low (200 parasites/µL) parasite density (Figs 21, 23, 25 and 27 and Figs 20, 22, 24 and 26, respectively), as little deterioration will not be apparent at high parasite density. The stability of pan-pLDH-detecting test lines was much poorer than that of HRP2-detecting test lines, at both high and low parasite density.
Most combination test products have pan lines that poorly detect low-density P. falciparum samples at baseline. Furthermore, tests with a baseline positivity < 100% showed unpredictable variation in positivity rates on subsequent testing, indicating that they were on the borderline of visi-bility. One of the two combination tests with good baseline pan line reactivity to the low-density sample showed a marked reduction in performance after 2 months at 35 °C or 45 °C. Some combination P. falciparum test lines were stable at 35 °C but lost the ability to detect antigen after incubation at 45 °C.
As reported previously, a few products showed better perfor-mance after incubation (Figs 21, 22, 24, 26, 27).
The results of heat and thermal stability testing are summa-rized in Table 6, and detailed results are presented in Annex 4 (tables A4.11–A4.13a) and in Figs 20–27, which show the results for the two lots combined (maximum score, 30; 15 tests per lot against 200 parasites/µL; maximum score, 10; 5 tests per lot against 2000 parasites/µL).
Re
sult
s
5150 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e 6:
Hea
t st
abili
ty t
estin
g re
sult
s fo
r 42
mal
aria
RDT
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(200
) an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/μL)
. Po
siti
vity
rat
e af
ter
60 d
ays
at b
asel
ine
(roo
m t
empe
ratu
re)
and
afte
r in
cuba
tion
at 3
5 °C
and
45
°Ca
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Posit
ive
test
res
ults
for
P.
fal
cipa
rum
(pan
line
)Po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
f lin
e)Po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (p
an li
ne)
200
para
sites
/μL
200
para
sites
/μL
2000
par
asite
s/μL
2000
par
asite
s/μL
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Base
line
35 °C
45 °C
Num
ber
of t
ests
pos
itive
(
max
. 30)
Num
ber
of t
ests
pos
itive
(m
ax. 3
0)N
umbe
r of
tes
ts p
ositi
ve
(max
. 10)
Num
ber
of t
ests
pos
itive
(m
ax. 1
0)Lo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
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1 a
nd 2
com
bine
dPf
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Adva
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Qua
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Prod
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falc
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Mal
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BioT
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9.0
9.0
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filia
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Firs
t Res
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alar
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g. p
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30.0
30.0
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10.0
10.0
10.0
10.0
10.0
10.0
Gen
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30.0
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10.0
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10.0
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10.0
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5352 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
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Posit
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NA
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lyAd
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a &
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ium
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lasm
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nd m
alar
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sitiv
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sults
pre
sent
ed in
the
tabl
e ar
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sed
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tabi
lity
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pos
itive
read
er 1
resu
lt
Tabl
e 6:
Hea
t st
abili
ty t
estin
g re
sult
s fo
r 42
mal
aria
RDT
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(200
) an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/μL)
. Po
siti
vity
rat
e af
ter
60 d
ays
at b
asel
ine
(roo
m t
empe
ratu
re)
and
afte
r in
cuba
tion
at 3
5 °C
and
45
°Ca
(con
tinue
d)
Re
sult
s
5352 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 20: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
SD BIOLINE Malaria Ag Pf - 05FK50/05FK53
Advanced QualityTM One Step Malaria Pf Test - ITP11002TC1/TC40
Advantage P.f Malaria Card - IR016025
CareStartTMMalaria HRP2 (Pf) - G0141
diagnosticks-Malaria (Pf) Cassette WB - KMFC6001
First Response® Malaria Ag P. falciparum (HRP2) Card Test - I13FRC
Immunoquick Malaria falciparum - 0502_K25
KHB® Malaria Ag P.f Rapid Test - KH-R-06-20
Vision Malaria Pf - VB01
0
20
30
10
Baseline 35 °C 45 °C
No.
of p
ositi
ve re
sults
from
two
lots
a
a Maximum score is 30 (15 tests x 2 lots)
Figure 21: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
diagnosticks-Malaria (Pf) Cassette WB - KMFC6001
Advanced QualityTM One Step Malaria Pf Test - ITP11002TC1/TC40
Vision Malaria Pf - VB01
SD BIOLINE Malaria Ag Pf - 05FK50/05FK53
Advantage P.f Malaria Card - IR016025
CareStartTM Malaria HRP2 (P f) - G0141
First Response® Malaria Ag P. falciparum (HRP2) Card Test - I13FRC
Immunoquick Malaria falciparum - 0502_K25
KHB® Malaria Ag P.f Rapid Test - KH-R-06-20
10
8
6
4
2
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 10 (5 tests x 2 lots);
5554 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 22: Heat stability of P. falciparum-specific test line in combination tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 25
Malaria Pf/Pan One Step Rapid Test - RT 20222
Malaria pf (pLDH) / PAN-pLDH Test Device - MFV-124
Advantage Mal Card - IR221025
Advantage Malaria Pan + Pf Card - IR231025
Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test - MAT-PF/PAN-50
MD Malaria Pf/Pan(pLDH) test - MDMALLDH001
NG-Test MALARIA Pf/Pan (pLDH) - NG-MAL-W23-001
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25
One Step Malaria P.F/P.V Test - 523352
CareStartTM Malaria HRP2/pLDH (P f/PAN) Combo - G0131
EzDxTM Malaria Pan/Pf Rapid Test Detection Kit - RK MAL 001
Parascreen® Rapid test for malaria Pan/Pf - 50310025
RightSignTM Malaria P.f./Pan Rapid Test Cassette - IMPN-C52
GenBodyTM Malaria Pf/Pan Ag - MALAG100
Wondfo® One Step Malaria P.f/P.v Whole Blood Test - W056-C
Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-322
ICT Malaria Dual Test - ML03
First Response® Malaria pLDH/HRP2 Combo Test - I16FRC
Genedia® Malaria P.f/Pan Ag Rapid Test - 20-0146-01
Vikia® Malaria Ag Pf/Pan - 412499
Advanced QualityTM Rapid Malaria Test (Pf/Pan) - ITP11005
ASAN Easy Test® Malaria Pf/Pan Ag - AM4650-K
BioTracerTM Malaria Pf/PAN Rapid Card - 17012
DIAQUICK Malaria P.f/Pan Cassette - Z11200CE
Humasis Malaria P.f/Pan Antigen Test - AMAL-7025
OnSite Pf/Pan Ag Rapid Test - R0113C
ParaHIT® fV Rapid test for P. falciparum and P.vivax Malaria - Device - 55IC402-50
Clearview® Malaria Dual - VB20
SD BIOLINE Malaria Ag P.f/Pan - 05FK60/05FK63
Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device - GM006
30
20
10
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 30 (15 tests x 2 lots)
Figure 23: Heat stability of P. falciparum-specific test line in combination tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
Clearview® Malaria Dual - VB20
OnSite Pf/Pan Ag Rapid Test - R0113C
Advanced QualityTMRapid Malaria Test (Pf/Pan) - ITP11005
BioTracerTMMalaria Pf/PAN Rapid Card - 17012
ASAN Easy Test® Malaria Pf/Pan Ag - AM4650-K
DIAQUICK Malaria P.f/Pan Cassette - Z11200CE
ParaHIT® fV Rapid test for P. falciparum and P.vivax Malaria - Device - 55IC402-50
First Response® Malaria pLDH/HRP2 Combo Test - I16FRC
Genedia® Malaria P.f/Pan Ag Rapid Test - 20-0146-01
Vikia® Malaria Ag Pf/Pan - 412499
ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 25
Malaria Pf/Pan One Step Rapid Test - RT 20222
Malaria pf (pLDH) / PAN-pLDH Test Device - MFV-124
Advantage Mal Card - IR221025
Advantage Malaria Pan + Pf Card - IR231025
MD Malaria Pf/Pan(pLDH) test - MDMALLDH001
Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test - MAT-PF/PAN-50
NG-Test MALARIA Pf/Pan (pLDH) - NG-MAL-W23-001
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25
One Step Malaria P.F/P.V Test - 523352
CareStartTMMalaria HRP2/pLDH (Pf/PAN) Combo - G0131
EzDxTMMalaria Pan/Pf Rapid Test Detection Kit - RK MAL 001
Parascreen® Rapid test for malaria Pan/Pf - 50310025
RightSignTMMalaria P.f./Pan Rapid Test Cassette - IMPN-C52
GenBodyTMMalaria Pf/Pan Ag - MALAG100
Humasis Malaria P.f/Pan Antigen Test - AMAL-7025
ICT Malaria Dual Test - ML03
SD BIOLINE Malaria Ag P.f/Pan - 05FK60/05FK63
Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device - GM006
Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-322
Wondfo® One Step Malaria P.f/P.v Whole Blood Test - W056-C
10
8
6
4
2
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 10 (5 tests x 2 lots)
Re
sult
s
5554 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 24: Heat stability of pan line of pan-specific tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
Advantage Pan Malaria Card - IR013025
CareStartTM Malaria pLDH (PAN) - G0111
30
20
10
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 30 (15 tests x 2 lots)
Figure 25: Heat stability of pan line of pan-specific tests against a high-density (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
Advantage Pan Malaria Card - IR013025
CareStartTMMalaria pLDH (PAN) - G0111
10
8
6
4
2
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 10 (5 tests x 2 lots)
5756 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure 26: Heat stability of pan line of combination tests against a low-density P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
BioTracerTM Malaria Pf/PAN Rapid Card - 17012
Advantage Malaria Pan + Pf Card - IR231025
Advantage Mal Card - IR221025
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25
CareStartTM Malaria HRP2/pLDH (Pf/PAN) Combo - G0131
Clearview® Malaria Dual - VB20
DIAQUICK Malaria P.f/Pan Cassette - Z11200CE
EzDxTM Malaria Pan/Pf Rapid Test Detection Kit - RK MAL 001
First Response® Malaria pLDH/HRP2 Combo Test - I16FRC
GenBodyTM Malaria Pf/Pan Ag - MALAG100
Genedia® Malaria P.f/Pan Ag Rapid Test - 20-0146-01
ICT Malaria Dual Test - ML03
Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-322
ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 25
Advanced QualityTM Rapid Malaria Test (Pf/Pan) - ITP11005
Humasis Malaria P.f/Pan Antigen Test - AMAL-7025Malaria Pf/Pan One Step Rapid Test - RT 20222
Malaria pf (pLDH) / PAN-pLDH Test Device - MFV-124
MD Malaria Pf/Pan(pLDH) test - MDMALLDH001
NG-Test MALARIA Pf/Pan (pLDH) - NG-MAL-W23-001
OnSite Pf/Pan Ag Rapid Test - R0113C
Parascreen® Rapid test for malaria Pan/Pf - 50310025RightSignTMMalaria P.f./Pan Rapid Test Cassette - IMPN-C52
SD BIOLINE Malaria Ag P.f/Pan - 05FK60/05FK63Vikia® Malaria Ag Pf/Pan - 412499
30
20
10
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 30 (15 tests x 2 lots)
Figure 27: Heat stability of pan line of combination tests against a high-density P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
Advantage Mal Card - IR221025
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25
BioTracerTM Malaria Pf/PAN Rapid Card - 17012
Clearview® Malaria Dual - VB20
Genedia® Malaria P.f/Pan Ag Rapid Test - 20-0146-01
Humasis Malaria P.f/Pan Antigen Test - AMAL-7025
Malaria pf (pLDH) / PAN-pLDH Test Device - MFV-124
Malaria Pf/Pan One Step Rapid Test - RT 20222Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-322
CareStartTM Malaria HRP2/pLDH (Pf/PAN) Combo - G0131
Advantage Malaria Pan + Pf Card - IR231025
EzDxTM Malaria Pan/Pf Rapid Test Detection Kit - RK MAL 001
DIAQUICK Malaria P.f/Pan Cassette - Z11200CEICT Malaria Dual Test - ML03Advanced QualityTM Rapid Malaria Test (Pf/Pan) - ITP11005ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 25
First Response® Malaria pLDH/HRP2 Combo Test - I16FRC
GenBodyTM Malaria Pf/Pan Ag - MALAG100
MD Malaria Pf/Pan(pLDH) test - MDMALLDH001NG-Test MALARIA Pf/Pan (pLDH) - NG-MAL-W23-001
OnSite Pf/Pan Ag Rapid Test - R0113C
Parascreen® Rapid test for malaria Pan/Pf - 50310025
RightSignTM Malaria P.f./Pan Rapid Test Cassette - IMPN-C52
SD BIOLINE Malaria Ag P.f/Pan - 05FK60/05FK63
Vikia® Malaria Ag Pf/Pan - 412499
10
8
6
4
2
0Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 10 (5 tests x 2 lots)
Re
sult
s
5756 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
14. ease-of-Use description and rdt anoMalies
After becoming proficient in using a product, two technicians produced a joint agreed assessment of product usability. The results, which are a description of the product with emphasis on aspects considered important for ease of use in the field, are presented in Table 7. It is important to note that the assessment does not include a comparison of blood transfer devices, which are critical to both the safety and the accuracy of the testing procedure and pose a significant challenge to many users. These may vary for manufacturers with many products. Procurement decisions should be based on which transfer devices are best suited for the intended users, and this should be discussed with the manufacture before procurement. It is strongly recommended that RDT packaging, contents, safety and ease of use be assessed in the field as part of the product selection process (Annex S2, Table AS2.1).
In round 5, technicians regularly recorded specific observa-tions (or anomalies) based on a list of problems encountered with some production lots evaluated in past rounds of testing and at WHO-FIND lot testing laboratories. Since March 2012, these observations have been included in all WHO-FIND lot testing reports and were recorded as part of product testing for the first time in round 5. Table 8 shows the percentages of products for which anomalies were observed in at least one of the RDTs tested; it does not give the frequency of the observation for a given product. Generally, users should be aware of major anomalies that may be encountered in production lots (Fig. AS2.1), as they can affect interpretation of RDT results.
Table 8: Observations on RDT production lots that might affect interpretation of the results
Observations/anomalies No.(%) of products with at least one recorded observation
Red background 42 (100)
Incomplete clearing 42 (100)
Failure to flow 26 (61.9)
Shift or misplacement of strip 10 (23.8)
Ghost lines 7 (16.7)
Diffuse test lines 2 (4.8)
Patchy broken test line 2 (4.8)
5958 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e 7:
Eas
e-of
-use
des
crip
tion
of 4
2 m
alar
ia R
DTs
incl
uded
in r
ound
5: W
HO
mal
aria
RDT
pro
duct
tes
ting
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
b
Com
-bi
ned
scor
e (m
ax. 5
)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Form
atLa
ngua
ge o
f in
stru
ctio
n Ite
ms
incl
uded
in p
acka
gec
Mix
ing
wells
in
volv
ed Re
tract
-ab
le
need
le
Strip
ex
pose
d Sc
ore
(max
. 3)
No
diag
ram
Diag
ram
of
resu
lt (1
)
Diag
ram
of
resu
lt
& m
etho
d (2
)
Scor
e (m
ax. 2
)
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
t IT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.1
11
3–
–X
25
115
Capi
llary
tu
beCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Adva
ntag
e P.
f Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.1
01
2–
–X
24
120
Pipe
tte
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (n
o co
lour
indi
cato
r)
Care
Star
t™ M
alar
ia H
RP2
(Pf)
G01
41Ac
cess
Bio
. Inc
.1
01
2–
–X
24
120
Pipe
tte
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (n
o co
lour
indi
cato
r)
diag
nost
icks
- M
alar
ia (P
f)Cas
sett
e W
BKM
FC60
01SS
A Di
agno
stic
s &
Bio
tech
Sy
stem
s1
01
2–
X–
13
120
Loop
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (c
olou
r ind
icat
or)
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um
(HRP
2) C
ard
Test
I13F
RCPr
emie
r Med
ical
Co
rpor
atio
n1
01
2–
–X
24
120
Pipe
tte
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (n
o co
lour
indi
cato
r)
IMM
UN
OQU
ICK®
MAL
ARIA
falc
ipar
um
0502
_K25
BIOS
YNEX
1
00
1–
–X
23
115
Non
eDi
pstic
kEn
glis
hTe
st tu
be, b
uffe
r, al
coho
l sw
ab, l
ance
t, de
ssic
ant (
no c
olou
r ind
icat
or)
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-en
gine
erin
g Co
.,Ltd
.1
11
3–
–X
25
115
Pipe
tte
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (n
o co
lour
indi
cato
r)
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
3St
anda
rd D
iagn
ostic
s In
c.
10
12
––
X2
41
15In
vert
ed
cup
Cass
ette
Engl
ish,
Fre
nch
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (c
olou
r ind
icat
or)
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(col
our i
ndic
ator
)Pf
and
pan
ACCU
CARE
ON
E ST
EP M
ALAR
IA P
f/Pa
n An
tigen
Tes
tM
AGC
25LA
B-CA
RE D
iagn
ostic
s (In
dia)
PVT
. LTD
.1
01
2–
–X
24
120
Pipe
tte
Cass
ette
Engl
ish
Non
e
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est
(Pf/
Pan)
IT
P110
05In
Tec
Prod
ucts
, Inc
.1
01
2–
–X
24
115
Capi
llary
tu
beCa
sset
teEn
glis
hN
one
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
BIOC
REDI
T Mal
aria
Ag
Pf/P
an (H
RPII/
pLDH
)C3
0RH
A25
Rapi
GEN
INC.
10
12
––
X2
41
30Ca
pilla
ry
tube
Cass
ette
Engl
ish
Non
e
BioT
race
r™ M
alar
ia P
f/PA
N R
apid
Car
d17
012
Bio
Focu
s Co
., Lt
d.1
01
2–
–X
24
120
Loop
Cass
ette
Engl
ish
Non
eCa
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/PA
N)
Com
boG
0131
Acce
ss B
io. I
nc.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Clea
rvie
w®
Mal
aria
Dua
lVB
20Or
geni
cs L
td.(I
S)1
01
2–
–X
24
125
Pipe
tte
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (c
olou
r ind
icat
or)
DIAQ
UIC
K M
alar
ia P
.f/Pa
n Ca
sset
teZ1
1200
CEDI
ALAB
Gm
bH1
01
2–
–X
24
120
Loop
Cass
ette
Engl
ish,
Ger
man
Non
e
EzDx
™ M
alar
ia P
an/P
f Rap
id Te
st D
etec
tion
Kit
RK M
AL 0
01Ad
vy C
hem
ical
Pvt
. Lt
d. (A
ffili
ate
of B
hara
t Se
rum
s &
Vac
cine
s Lt
d. )
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hN
one
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stI1
6FRC
Prem
ier M
edic
al
Corp
orat
ion
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Gen
Body
™M
alar
ia P
f/Pa
n Ag
MAL
AG10
0G
enBo
dy In
c.1
01
2–
X–
13
130
Loop
Cass
ette
Engl
ish
Non
e
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01G
reen
Cro
ss M
edic
al
Scie
nce
Corp
. (Ko
rea)
11
13
––
X2
51
15Lo
opCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Hum
asis
Mal
aria
Pf/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
10
12
––
X2
41
30Lo
opCa
sset
teEn
glis
h, F
renc
h,
Span
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (n
o co
lour
indi
cato
r)
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL1
01
2–
–X
24
130
Inve
rted
cu
pCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(col
our i
ndic
ator
)
Re
sult
s
5958 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
b
Com
-bi
ned
scor
e (m
ax. 5
)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Form
atLa
ngua
ge o
f in
stru
ctio
n Ite
ms
incl
uded
in p
acka
gec
Mix
ing
wells
in
volv
ed Re
tract
-ab
le
need
le
Strip
ex
pose
d Sc
ore
(max
. 3)
No
diag
ram
Diag
ram
of
resu
lt (1
)
Diag
ram
of
resu
lt
& m
etho
d (2
)
Scor
e (m
ax. 2
)
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pan
) Tes
t Kit
A03-
18-3
22Ar
tron
Lab
orat
orie
s In
c.1
01
2–
–X
24
130
Non
eCa
sset
teEn
glis
hN
one
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hN
one
Mal
aria
pf-
LDH/
PAN-
LDH
Antig
en Te
st D
evice
MFV
-124
AZOG
, IN
C.1
01
2–
–X
24
120
Non
eCa
sset
teEn
glis
hN
one
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH0
01M
edic
al D
iagn
oste
ch
(Pty
) Ltd
10
12
––
X2
41
30Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(col
our i
ndic
ator
)
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
-M
AL-W
23-0
01SA
RL N
G B
iote
ch, Z
.A.
10
12
––
X2
41
30Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(col
our i
ndic
ator
)On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech
Inc.
10
12
––
X2
41
30Lo
opCa
sset
teEn
glis
hN
one
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
10
12
–X
–1
31
20Lo
opCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(col
our i
ndic
ator
)Ri
ghtS
ign™
Mal
aria
P.f.
/Pan
Rap
id T
est
Cass
ette
IMPN
-C52
Han
gzho
u Bi
otes
t Bio
tech
Co
. Ltd
.1
01
2–
–X
24
110
Pipe
tte
Cass
ette
Engl
ish
Non
e
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
10
12
––
X2
41
15In
vert
ed
cup
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (c
olou
r ind
icat
or)
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
10
12
––
X2
41
20Pi
pett
eCa
sset
te
Dani
sh, E
nglis
h,
Fren
ch, G
erm
an,
Gre
ek, I
talia
n,
Polis
h, P
ortu
gues
e,
Span
ish,
Sw
edis
h
Non
e
Pf a
nd P
v/Pv
om
ASAN
Eas
y Te
st®
Mal
aria
Pf/
Pan
AgAM
4650
-KAS
AN P
harm
aceu
tical
Co
., Lt
d 1
01
2–
–X
24
130
Loop
Cass
ette
Engl
ish
Non
e
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
De
tect
ion
Test
Dev
ice
GM
006
Gen
omix
Mol
ecul
ar
Diag
nost
ics
Pvt.
Ltd.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o)
3 Li
ne A
ntig
en T
est
MAT
-PF/
PAN
-50
Bhat
Bio
-Tec
h In
dia
(P) L
td.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(col
our i
ndic
ator
)
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
10
12
––
X2
41
15N
one
Cass
ette
Engl
ish
Non
e
Para
HIT
®fV
Rapi
d te
st fo
r P. f
alci
paru
m
and
P. v
ivax
Mal
aria
- D
evic
e55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
11
13
––
X2
51
25Ca
pilla
ry
tube
Cass
ette
Engl
ish
Buff
er, a
lcoh
ol s
wab
, lan
cet,
dess
ican
t (n
o co
lour
indi
cato
r)W
ondf
o® O
ne S
tep
Mal
aria
P.f/
P.v
Who
le
Bloo
d Te
stW
056-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
10
12
––
X2
41
15Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
10
12
––
X2
41
20Pi
pett
eCa
sset
teEn
glis
hBu
ffer
, alc
ohol
sw
ab, l
ance
t, de
ssic
ant
(no
colo
ur in
dica
tor)
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
s P
vom
, Pla
smod
ium
viv
ax, o
vale
and
mal
aria
ea
Mix
ing
wel
ls in
volv
ed: Y
es=0
; No=
1; re
trac
tabl
e ne
edle
: yes
=1; n
o=0;
str
ip e
xpos
ed, n
ot w
ithin
car
d or
cas
sett
e: e
xpos
ed=0
, cov
ered
=1b
No
diag
ram
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6160 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
15. discUssion of keY findings
This report describes the performance of many of the available malaria antigen-detecting RDTs manufactured under the ISO 13485:2003 quality standard. Malaria RDTs can greatly improve the management of febrile illness in malaria-endemic areas. To be useful in this context, they must have adequate:
• sensitivity, to detect nearly all clinically significant cases of malaria;
• specificity, to accurately discriminate non-malarial febrile illness from malaria, to ensure appropriate management and accurate disease monitoring;
• stability, to maintain accuracy after transport and storage in ambient conditions; and
• ease-of-use and safety, to allow safe, correct preparation and accurate interpretation of results.
Malaria RDTs were evaluated in terms of these four major requirements in order to assist national malaria control programmes and other procurement agencies in selecting products appropriate for their needs. The panel used allowed successful discrimination between the RDTs evaluated, which had a considerable range of performance. A number of products showed a high rate of antigen detection combined with a low false-positive rate and good heat (thermal) stability. These attributes are essential if the tests are to be relied upon as a basis for decisions about malaria treatment in most endemic populations.
Overall, the mean product PDS against low-density P. falci-parum samples in round 5 was 81.0%, consistent with the results of round 4 (81.6%) and suggesting that performance may be plateauing after several rounds of improvement.1 For P. vivax, the mean PDS of 61.3% is the highest achieved.2 The median false-positive rate was 1.3%, which is comparable with that in previous rounds; however, in rounds 4 and 5, a limited number of products returned exceptionally high false-positive rates. Overall, a high level of performance has been maintained in P. falciparum-only tests and improved performance in P. vivax-detecting RDTs.
Ten products tested in round 1 of the programme were resubmitted for testing in round 5. The performance of most of the products was comparable 5 years after the initial testing; only one that had previously fulfilled the WHO procurement criteria no longer does. Another product showed improved performance and fulfilled the WHO procurement criteria when it previously did not.
The evaluation is performed against a standardized panel of cultured P. falciparum and frozen blood samples by expe-rienced technicians in a research laboratory and is not
1 PDS for P. falciparum in rounds 1, 2 and 3 was 67.2%, 69.9%, 75.5%, respectively.
2 PDS for P. vivax in rounds 1, 2, 3 and 4 was 36.0%, 58.9%, 47.1% and 51.3%, respectively.
therefore a field evaluation of the accuracy of RDTs in a specific epidemiological context in the hands of the intended users. The panel is designed to mimic fresh blood samples from actual cases as closely as possible, while allowing direct comparison of a large number of products simultaneously with control for confounding factors and is calibrated to a level likely to discriminate differences in the performance of various products. The discussion points described below should therefore be taken into account in interpreting the results.
15.1. panel detection score and its relation to sensitivity Evaluation of the RDTs against the phase-2 wild-type parasite panel with a parasite density of 200 parasites/µL (Figs 10 and 11) revealed a wide range of frequency and consistency of antigen detection between products, recorded as the PDS. As expected, testing at higher parasite density (2000 or 5000 parasites/µL) resulted in smaller differences in performance. As two tests from two different lots were tested at 200 parasites/µL and as all four results had to be positive in order for a sample to be considered detected by an RDT, a positive result indicated the ability of a product to detect the target antigen in the sample and to do this consistently (both tests from both lots). A parasite density of about 200 parasites/µL should be detected to ensure high field sensitivity for clinically significant malaria infection in many malaria-endemic populations (9).
The PDS in the panels used in this evaluation differs from the test sensitivity in clinical settings for five main reasons.
(i) The performance of different lots or batches of the same product may vary. Variation in lot performance is an issue for all diagnostics; therefore, the results found in the evaluation may not predict the results for subsequent RDT lots. It is important to test lots before their distribution in the field to ensure that the expected performance is maintained (section 15.2).
(ii) In clinical settings, patients show wide variation in parasite density, the range depending on the local epidemiology of the disease. The parasite density in the population tested affects the clinical sensitivity of a test. The PDS against a test panel of blood samples diluted to 200 parasites/µL is likely to underestimate the clinical sensitivity of an RDT in areas where symptomatic patients have much higher parasite densities. Many tests that show only moderate detection of the 200-parasites/µL panel may perform well in such settings, as indicated by the better PDS of most products against the panel at 2000 parasites/µL. The small differences in PDS seen in Figs S1, S2 and 9–11 and Tables 4 and 5 found among the better-performing RDTs in this evaluation are unlikely to result in noticeable differences in clinical sensitivity,
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and other issues, such as stability, cost, experience and training of the intended users, ease of use (Annex S2) andmanufacturingcapacitymaybeequallyimportantfactors in test selection. Consideration of the parasite density in target populations and the probable sensitivity of RDTs in the field indicates that, even in areas with high transmission and strong malaria immunity, the population may include individuals with a low parasite density but clinically significant infection (e.g. young children, pregnant women, people who regularly use bed nets, immigrants and people with reduced immunity). The ability to detect low parasite-density infections reliably, therefore, remains important. As some countries move towards elimination of malaria, population immunity will decrease and/or clinical cases may be detected earlier, and it will become increasingly important to use diagnostic tests that detect low parasite density (i.e. with a high PDS against samples with 200 parasites/µL).
(iii) The performance of tests against the challenge panel may not always predict sensitivity in clinical testing, e.g. when antigen expression by certain parasite populations differs greatly from that in the panel. For example, P. falciparum strains in some areas of India and South America do not express HRP2 antigens because of gene deletions (10, 11). If a significant proportion of parasites in a given area do not express HRP2 and HRP3, tests to detect other target antigens (e.g. pLDH or aldolase) must be used. To date, parasite populations with a high frequency of non-expression of target antigens have not been identified elsewhere than South America.1
(iv) The conditions under which RDTs are transported and stored can alter their sensitivity in the field. The tests evaluated in round 5 were shipped and stored under conditions intended to safeguard them from degradation by high temperature or other extreme conditions. If such precautions are not taken with purchased RDTs, loss of performance could result. The ambient temperature of storage conditions varies widely in the settings in which these tests are commonly used, as does the temperature during transport; therefore, the requirements for the heat stability of a product will differ. Tests should be transported and stored well within the temperature range recommended by the manufacturer and extremes of temperature avoided (31, 32).
(v) Diagnostic sensitivity and specificity depend on the quality of preparation and interpretation of the tests. Highly trained technicians tested all the products in this evaluation. In clinical settings, malaria RDTs are often used by health workers with limited training and supervision; therefore, simple design and clearly interpretable results are required to ensure translation of the technical proficiency of a product into accurate diagnoses in the field (33).
1 Cheng Q, Gatton M, Barnwell J, et al. Plasmodium falciparum parasites lacking histidine-rich protein 2 and 3: a review and recommendations for accurate reporting. Acceptedfor publication.
15.2. false-positive rate and specificity False-positive rates are reported against a panel of 59 clean-negative samples taken from blood donated in low-transmission settings by people without symptoms of malaria. In addition, false-positive rates were calculated with a smaller number of samples with specific characteristics that affect the likelihood of a false-positive result from an immunodiagnostic test (e.g. rheumatoid factor, anti-nuclear antibody) or that may be significant in a specific population in a malaria-endemic area (e.g. leishmaniasis, dengue). The importance of these results depends on the intended area of use. High false-positive rates with samples of blood from dengue patients, for example, might not be a significant factor in regions in which dengue does not occur. In view of the small number of samples in each category in this evaluation, the results should be considered primarily a guide to potential cross-reactions, which should be closely monitored if they are relevant to the target population.
In general, it is preferable to procure a product with a low rate of false-positive reactions. In the case of many diagnostic tests, a trade-off must be made between a preference for a high rate of antigen detection (sensitivity) and a low false-positive rate (specificity). The context in which the test will be used will guide the relative importance of these two factors in the choice of one product over another. Overall, in this evaluation, there was no correlation between a lower PDS (loss of sensitivity) and a low false-positive rate (high specificity). A number of products had both a high PDS and a low false-positive rate.
15.3. reactivity of combination Hrp2 and pan-pldH test lines against P. falciparum samplesInstructions for the use of P. falciparum/pan and pan/P. falci-parum combination tests classify P. falciparum infections as either HRP2 test line-positive alone or in combination with the pan-pLDH line. Combination tests that return only a positive HRP2 test line may be incorrectly interpreted as false-positives for malaria infection secondary to persistent (HRP2) antigenaemia. The results in this report clearly indicate that most combination tests in which HPR2 is used for the detection of P. falciparum return positive results only on the HRP2 band at lower densities of P. falciparum (Table A4.2). When both the HRP2 and the pan test bands were positive, the mean band intensity was significantly lower on the pan test band than on the HRP2 test band. Therefore, it is important to reinforce adherence to the manufacturer’s instructions for use (Annex 2) and to emphasize that for combination HRP2/pan-pLDH tests, a HRP2 test line-positive alone, may well be attributed to the poor reactivity of pan-pLDH lines.
6362 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
15.4. Heat (thermal) stability The RDTs evaluated were held for 2 months at room tempera-ture (< 25 °C) and at 35 °C and 45 °C at 75% humidity and tested to evaluate stability at these temperatures. The importance of thermal stability depends on the conditions under which a product will be transported and stored. Thus, stability at high temperatures is vital if an RDT is to be stored at clinics in a country where the ambient temperature can reach 45 °C in the hot season but is less critical in a high-altitude or cooler environment where the temperature rarely rises above 35 °C. Many commercially available RDTs indicate 30 °C or 40 °C as the maximal storage temperature. Higher temperatures were tested in this evaluation because malaria-endemic countries often have maximum ambient temperatures of 35 °C, although use of cool storage can allow storage of products below this temperature. When RDTs are likely to be transported and stored at high ambient temperatures, heat (thermal) stability must be considered a significant factor in ensuring sensitivity.
High humidity accelerates the degradation of malaria RDTs and other lateral flow tests. All the products in this evaluation were packaged in individual envelopes containing a desiccant and are designed to be moisture-proof. This allows the user to open the envelope of a test at the time of use, limiting exposure to high humidity. During the stability-testing phase of this evaluation, the RDTs were stored at 75% humidity. The packaging should, if in good condition, protect the contents from exposure to high humidity during storage. The results presented here provide an assessment of both the stability of the RDT and the quality of its packaging.
A limitation of our evaluation is that we can assess only the stability of test lines to detect cultured P. falciparum samples. Several products showed high stability at the temperatures and times used in the evaluation. In general, in this round, as in previous ones, pan-specific lines (pLDH) performed less well at baseline and were less stable than HRP2 test lines, so that it was difficult to assess post-incubation stability.
While the temperature and humidity were held constant in this evaluation, temperatures in the field fluctuate with the time of day and season. Two months’ storage at a set temperature cannot accurately predict long-term stability under field conditions, but loss of sensitivity for parasite detection over this period indicates that significant sensi-tivity will be lost if RDTs are stored at similar or higher temperatures for a significant amount of their storage time and the likelihood of greater susceptibility to degradation during short exposure to much higher temperatures, such as during transport (34, 35).
15.5. ease-of-use description and rdt anomalies in production lotsThe sensitivity and specificity of RDTs depend on the quality of preparation and interpretation. In general, a simpler format with fewer steps or fewer required extraneous materials is likely to be prepared and interpreted more reliably. Thus, cassette-format RDTs are generally more reliably prepared and interpreted than products in dipstick format (36). The extra cost of this format may be offset by the advantages of greater accuracy and, in some cases, less additional equipment required to perform them.
The method by which blood is transferred from the patient to the test is important for the safety of the user and for the accuracy of the volume transferred. Devices for blood transfer are supplied with RDTs and vary widely in design and accuracy (30). The performance of blood transfer devices was not formally assessed in this evaluation, as blood was transferred from a tube with a micro-pipette to ensure that the volume specified by the manufacturer was used. Procurement programmes for RDTs should consider the adequacyofthebloodtransferdevicesupplied,includingthe experience of health workers and the cost and time requiredforretraining.It may be appropriate to discuss with manufacturers the possibility of changing the blood transfer device from that usually supplied.
The clarity of results is important for interpreting tests. A clearly visible (intense) test line is less likely to be overlooked than a line that is barely visible. While reading proficiency and adequate workplaces should be ensured, some health workers might have suboptimal vision or work in inadequate lighting. The intensity of the line of the test band was found to be closely associated with the PDS achieved by RDTs (tables A4.2 and A4.3).
The importance of format and the simplicity of the test design depend on the intended users. Trained laboratory technicians can handle a complicated procedure more reli-ably than village volunteers with limited supervision. In all cases, proficiency-based training and adequate supervision should be included in any RDT-based diagnostic programme, and clear instructions should be provided in a language and format appropriate for the user (37, 38). Annex S2 provides guidance on conducting a field-based ease-of-use assess-ment (Table AS3.1).
In the production lots submitted for evaluation, anomalies that affected interpretation of the results were encountered withvariablefrequency.Onthebasisoftheexperienceofseveral rounds of product testing, with 2700 lots tested in the WHO-FIND lot testing programme, a glossary of RDT anomalies has been prepared (Figure AS2.1). This glossary may be used in RDT training programmes to illustrate potential problems with some production lots and how to report them accurately. As many of the anomalies are infrequent,theymightnotbepickedupinmanufacturers’qualitycontrolorlotreleaseprocedures;therefore,thisinformation is also useful for manufacturers that wish to improve their processes.
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15.6. inter-lot variation The testing programme evaluated only two production lots of each product. Malaria RDTs are complex biological products made up of components that are commonly supplied from different sources and are subject to a variety of conditions during manufacture that may affect the quality of the final product. All manufacturers that entered this evaluation provided at least one current ISO 13485:2003 certificate for a manufacturing facility. This standard is designed to ensure consistency in the quality of the final product, if correctly implemented. The results presented here indicate that inter-lot variation does occur, and WHO strongly recommends that a sample of RDTs from each production lot be tested before their dissemination to the field, to ensure that they meet an appropriate standard. This can be facilitated by WHO through two WHO-recognized lot testing facilities (section 15.2).
Inter-test variation, which is also seen, will be detected to some extent by routine lot testing. Ensuring that manufac-turers follow good manufacturing standards should minimize the likelihood of inconsistencies due to poor practice in the manufacturing process. Culture-based panels1 that are subsets of the phase-1 panel used in this evaluation are available as reference standards for manufacturers against which to set their lot-release criteria.
15.7. target antigens and speciesThe malaria RDTs assessed in this evaluation detect one or more of three parasite antigens, HRP2, pLDH and aldolase, in various combinations. HRP2 is present only in P. falciparum, whereas aldolase and pLDH are present in all four species and may be used as pan or all-species targets. Some tests use differences in pLDH sequences between species as a means to differentiate P. falciparum from P. vivax and other species. There is considerable overlap in the PDS of products that target the different antigens in this evaluation. While
1 To access these panels, contact [email protected], [email protected] or [email protected].
the products with the highest PDS for P. falciparum targeted HRP2, a number of pLDH-detecting products had high PDS against P. vivax. The thermal stability of tests that target these different antigens also overlapped for samples with high parasite density.
The choice of RDT should take into account the target antigen: HRP2-detecting RDTs should not be used in areas where non-expression of HRP2 is common (10, 11). Tests that detect only HRP2 (without pLDH or aldolase lines) will be of limited use where non-falciparum malaria is common. pLDH (and possibly aldolase) RDTs may have further advantages when antigen persistence (common with HRP2) may result in a high false-positive rate in areas where early retesting in the weeks immediately after treatment is common. As mentioned in section 14.3, however, combination tests with both HRP2 and pan test lines should not be used for discriminating between acute infection and persistent antigenaemia, as the overall reactivity of pan test lines is much lower than that of HRP2 test lines, particularly at low parasite density.
The required sensitivity of a test may also vary by species: a less sensitive test may be more acceptable for detection of P. vivax than for P. falciparum, as severe outcomes due to missed diagnoses are less likely. Use of a sufficiently sensitive pan-specific-only test may be appropriate in areas where both P. falciparum and P. vivax occur, if all infections are to be managed initially as P. falciparum infections with artemisinin-based combination therapy, but species-specific monitoring data would be lost. Tests with high PDS for both P. falciparum and P. vivax were found in this and previous rounds of product testing (3–6).
Pan-species tests were not evaluated for detection of P. ovale or P. malariae in this evaluation because of lack of sources of suitable mono-species infections with these parasites. Published data suggest that the sensitivity of RDTs for detecting these species is significantly poorer than for P. falciparum and P. vivax (39).
6564 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
16. Using resUlts to ensUre HigH-QUalitY diagnosis in tHe field
This report provides data to guide malaria control programmes in selecting products that are likely to perform to a high standard in the context in which the programme operates. Final product selection requires that these data be considered systematically, taking into context the distribution of parasite density in the target population in whom the tests will be used and the experience and training of the intended users. Box 3 lists WHO’s minimum RDT selection criteria, as endorsed by the Malaria Policy Advisory Committee, and tables S2, and 5 are colour-coded to reflect these minimum performance criteria for product selection. A web-based tool for filtering product testing results by various parameters is available and maintained by FIND.1 Furthermore, an algorithm to guide selection is given in Annex S3, and detailed guidance was published by WHO in Good practices for selecting and procuring rapid diagnostic tests for malaria (13) and Universal access to malaria diagnostic testing (14).
While malaria RDTs can be used in a number of settings, the greatest impact on public health will be brought about by extending access to accurate, parasite-based diagnoses of malaria to regions and populations where good-quality microscopy-based analysis is impractical to maintain. This will allow implementation of recent WHO recommendations on universal parasite-based diagnosis before antimalarial therapy (2) and currently applies to most people at risk for malaria in endemic countries (1). In many settings where RDTs have been introduced, the true rate of parasitaemia has been found to be considerably lower than expected, so that health systems can reduce wastage of antimalarial medicines and focus on appropriate management of non-malarial causes of fever, including early pneumonia and sepsis. A successful RDT programme must therefore address not only malaria but also the management of other common and severe febrile illnesses that occur locally in the differential diagnosis of malaria if an RDT programme is to have its full potential public health impact.
16.1. beyond procurementDiagnostic tests usually represent the start of a health system intervention, and their use is based on the assumption that appropriate patient management, based on testing, will follow. Thus, successful introduction of RDTs requires careful planning beyond rational procurement to ensure consistent
1 http://www.finddiagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp. An interactive guide designed to short-list tests according to programme needs, based on the performance of tests in rounds 2–5 of the WHO product testing programme, can be found at: http://www.find-diagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp (accessed 27 May 2014).
supplies of all the necessary materials (including gloves, sharps disposal containers and supplies required for further case management), training of users, community sensitization and monitoring of diagnostic quality and results. This extends malaria management to management of other febrile diseases and health service delivery systems and requires integration with other health programmes.
This report provides information to guide procurement of RDTs within this framework. Factors beyond the perfor-mance characteristics reported here, however, must influence procurement decisions. An example of an algorithm, including an ease-of-use assessment, is provided to guide decisions in annexes S2 and S3.
Details of implementation will vary widely between programmes, depending on local capacity and needs. Further recommendations on budgeting, planning and implementation can be found in Annex 5 and in the relevant WHO guidance document (14).
16.2. lot testingAs a complement to product testing, WHO and FIND currently support laboratories that perform continued quality assurance of RDTs in the form of lot testing. This programme responds to requests from national malaria programmes, manufacturers and procurement bodies to assess the quality of RDT lots before purchase or, when they arrive in a country, before dispersal to the field and for clinical use. Testing is performed against parasite-positive and -negative panels prepared and characterized in the same way as the panels used in this evaluation. A number of national institutions have also developed this capacity. Lot testing reassures countries that the product they have purchased performs to a high standard before distribution and helps to ensure that manufacturers produce consistently good lots and improve their products.
Countries and manufacturers ship 100–150 RDTs to regional, WHO-recognized lot testing centres, where they are evaluated against a small panel of parasites at high and low density and against negative samples (Figure 2). They are subsequently incubated at a temperature close to the manufacturer’s speci-fied storage temperature and retested after 18 months. Initial results are available after 5 days, and definitive results after subsequent retesting. Details of the protocol can be found in the methods manual for lot testing (25). National malaria programmes and procurement agencies are encouraged to participate in the lot-testing programme.
To access lot-testing through the WHO-FIND programme, contact [email protected] or [email protected] at least 2 weeks before RDTs are ready for shipment.
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17. conclUsions
This report adds to the large data set on malaria RDT perfor-mance published annually since 2009 (3–6). The product-testing programme continues to be an authoritative source in the field of malaria RDT evaluations in terms of the number of products evaluated and its comprehensiveness. New laboratory methods have been developed and validated to support parasite characterization, and this work has gener-ated new findings on variation in antigen content at similar parasite densities and in the structure and expression of HRP
proteins. Publication of the results of past WHO product testing rounds has affected the procurement practices of countries and procurement agencies and contributed to a shift in the malaria RDT market towards better-performing products (1). The report of round 5 adds to the number of well-performing RDTs for which comprehensive performance data are now available and provides updated data on 23 products resubmissions.
18. references
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36. Rennie W, Phetsouvanh R, Lupisan S, et al., Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg 2007; 101(1): 9–18.
37. Harvey SA, Jennings L, Chinyama M, et al., Improving community health worker use of malaria rapid diag-nostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J 2008; 7(1): 160.
38. Tavrow P, Knebel E, Cogswell L. Using quality design to improve malaria rapid diagnostic tests in Malawi. In: Operations research results 2000; 1(4). 2000. Bethesda, Maryland: United States Agency for International Development.
39. Heutmekers M, Gillet P, Maltha J, et al. Evaluation of the rapid diagnostic test CareStart pLDH Malaria (Pf-pLDH/panpLDH) for the diagnosis of malaria in a reference setting. Malar J 2012; 11: 204.
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6766 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
anneXes
6968 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
annex s1: characteristics of evaluation panels used in rounds 1–5 of WHo malaria rdt product testing, 2008–2013Currently, the basis for diagnosing malaria with antigen-detecting RDTs is the detection in a patient’s blood of one or more target malaria antigens, including HRP2 (P. falciparum only), pLDH (Plasmodium spp.(pan-pLDH), P. falciparum (Pf-pLDH), non-falciparum (Pv-pLDH, Pvom-pLDH) and aldolase (all Plasmodium spp). The antigen concentration in samples with the same parasite density varies. Therefore, the concentrations of malaria antigens in the samples that comprise evaluation panels must be consistent in successive rounds of WHO malaria RDT product testing to ensure that the results of each round are highly comparable (statistically equivalent).
Therefore, antigen concentrations were quantified in triplicate in all panel samples, including dilution pairs of 200 and 2000 parasites/µL, by quantitative ELISA. Only results that were consistent in the triplicate runs and showed a value factor between the 200 and the 2000 parasites/µL dilutions close to 10 were considered acceptable and eligible for the performance evaluation panel. In some instances, the antigen concentration was below the detection limit of the ELISA, particularly for aldolase, which is present in malaria parasite samples at much lower concentrations than the other two antigens. Samples that gave inconsistent results for more than one of the three antigens were excluded from the panel.
Despite careful standardization of procedures, the tables and figures below show a wide variation in antigen concentra-tions for the same parasite density. There are a number of possible explanations, including differences in the level of antigen expression by isolates; different durations of infection (accumulating antigens); different parasite growth stages at the time of collection (expressing different levels of antigen); the presence of circulating HRP2 from previous growth cycles; and HRP2 produced by parasites sequestered in the host’s vascular tissues that cannot be accounted for in the estimate of parasite density on the blood slide.
Before each round of WHO malaria RDT product testing, the distribution of HRP2, pLDH and aldolase concentrations at 200 parasites/µL dilution of the wild-type P. falciparum and wild-type P. vivax samples selected for the phase-2 panels were systematically compared with those in the previous round to ensure there was no statistically significant differ-ence. The figures and tables below show the distribution of antigen concentrations in all five performance evaluation panels. No statistically significant differences were seen (Kruskal-Wallis test; p > 0.15), confirming that the results of each new round are additive (and comparable) to the previous ones. In the following box and whisker plots, the end of whiskers represent minimum and maximum values; the box represents middle 50% of data and the line through box represents median values; the crosses represent the mean values.
Figure AS1.1: Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wildtype) panels.
10.5 2 4 8 16 32 64 128
P. falciparum HRP2 concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.3: Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
1 2 4 8 16 32 64
P. vivax pLDH concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.2: Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wildtype) panels.
0.5
0.25
0.12
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P. falciparum pLDH concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.4: Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
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Round 5
Round 4
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Round 2
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6968 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure AS1.5: Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
1 2 4 8 16P. vivax aldolase concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 78 99 99 98 99
Minimum 0.80 0.62 0.62 0.62 0.62
25% percentile 2.90 1.90 2.10 2.97 3.00
Median 9.57 6.76 6.83 6.98 7.05
75% percentile 18.94 16.91 17.37 15.65 15.31
Maximum 73.70 73.70 66.70 62.48 62.48
Mean 15.28 12.70 12.77 12.72 11.74
Std. Deviation 16.98 15.75 15.19 14.72 13.20a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 74 93 92 92 94
Minimum 0.71 0.19 0.19 0.19 0.19
25% percentile 6.68 6.27 6.23 6.20 6.90
Median 11.95 10.31 11.18 10.92 12.24
75% percentile 23.75 20.10 22.70 21.28 23.05
Maximum 47.15 47.15 47.15 53.53 43.02
Mean 15.31 13.71 15.08 14.97 15.53
Std. Deviation 11.47 10.90 11.72 11.98 11.43a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in wildtype product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 20 37 33 32 34
Minimum 5.10 1.64 1.64 1.64 1.64
25% percentile 8.10 8.40 7.30 6.96 6.26
Median 12.65 17.00 19.78 17.50 13.22
75% percentile 27.40 29.69 31.89 29.84 23.42
Maximum 44.40 47.90 47.90 47.90 47.90
Mean 17.38 20.24 20.99 20.00 16.84
Std. Deviation 11.57 13.27 13.55 13.00 12.59a The number of values is the number of samples for which consistent ELISA results were obtained.
7170 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 77 98 99 98 99
Minimum 0.00 0.00 0.00 0.00 0.00
25% percentile 0.84 0.74 0.67 0.63 0.52
Median 1.61 1.49 1.40 1.25 1.17
75% percentile 2.25 2.25 2.23 2.25 2.07
Maximum 9.90 9.90 9.90 9.08 7.74
Mean 1.93 1.79 1.76 1.72 1.52
Std. Deviation 1.73 1.66 1.69 1.68 1.52a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 20 40 34 33 35
Minimum 3.21 1.70 1.70 1.70 3.21
25% Percentile 4.02 4.11 4.07 4.41 5.55
Median 6.33 6.15 6.10 6.16 6.86
75% Percentile 8.47 8.47 8.32 9.10 9.43
Maximum 13.15 13.40 13.30 15.00 15.00
Mean 6.73 6.81 6.45 6.86 7.78
Std. Deviation 2.89 3.15 2.90 3.23 3.30a The number of values is the number of samples for which consistent ELISA results were obtained.
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7170 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
annex s2: Malaria rdt field assessment and anomaliesThe purpose of this assessment, on a limited number of RDTs, is to assess aspects of packaging, safety and ease-of-use and not to evaluate diagnostic accuracy.
Obtain samples of each malaria RDT under consideration (at least one box packaged as intended for delivery to end users).
Obtain malaria parasite-negative blood samples, and where readily accessible, parasite-positive blood samples for testing against RDTs.
Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Date of assessment Commercial name Catalogue number Lot number(s)
Yes No NA Problems /CommentsPackaging and accessories
The RDT box is in good conditionRDTs are in individual sealed pouches
The correctly indicated number of RDTs are in the boxA desiccant is included in each individual RDT pouch
An expiry date is visible on each RDT pouchAll required accessories are included in the correct quantities
(RDT, buffer, blood transfer device, alcohol swab, lancet, gloves, test tubes (for dipsticks, only)
If no, what is not included:
InstructionsInstructions are included
Instructions are in the national language(s)The instructions are for the correct product The instructions include figures displaying
all possible interpretations of the RDT resultsThe text and figures are accurate and consistent
(specifically order of test lines and results interpretation)Preparation and procedure
The test pouch is easy to openIt is easy to write on the test device
The test lines on the device are clearly labelledIt is easy to use the device for blood collectionIt is easy to open the buffer bottle or ampoule
The buffer bottle or ampoules have sufficient volume for testing all RDTs in the box
The buffer bottle or ampoule dispenses even dropsIt is easy to fill the sample well correctly with the provided blood
transfer deviceIt is easy to fill the buffer well correctly (no overflow)
The buffer and sample flow well along the test strip Result interpretationControl and test lines
Control line is clearTest line(s) are clear
Good clearance of blood by time of reading If no, number of tests in the box affected:
Steps and reading time Reading time <30 min
Two or fewer timed steps Was one or more of the last 10 tests
you performed invalid (no control line)?If YES, how many?
SafetyAre there mixing wells (risk of blood splash)?
Retractable needle for finger prick?Is the RDT in a cassette format (unexposed strip)?
Have waste disposal safety concerns been addressed? (If no, please describe)
7372 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure AS2.1 illustrates examples of RDT observations/anomalies encountered and routinely recorded during Round 5 of WHO Malaria RDT Product Testing at the CDC. In most cases, these anomalies do not invalidate the results, as reactivity in the control and test line areas are still visible, but they may pose challenges to health workers interpreting the results. Furthermore, they should be reported to manufacturers.
An expanded list of notable observations concerning RDT packaging, kit accessories (buffer vials, desiccants) and instruc-tions for use, is under development for use in both product testing and lot testing activities of the WHO-FIND Malaria RDT Evaluation Programme.
Figure AS2.1: Malaria RDT anomalies encountered in production lots
a) Observations on the test strip
Red background Background staining is relatively common. In this example, the result is positive as test lines are positive; however, a more intense red background may obscure weak positive test lines, giving false-negative results
Incomplete clearing Poor clearing of blood may obscure weak positive test lines, giving false-negative results. In this example, the result is positive as the test line is visible
b) Observations of flow problems
Failure to flow Blood and buffer did not run the length of the strip
Irregular migration that obscures test line(s)
One portion of the nitrocellulose near the test band was not absorptive and remained dry during wicking, creating irregular migra-tion of blood/buffer with red background that may obscure test line.
Irregular migration One portion of the nitrocellulose near the test band was not absorptive and remained dry during wicking, creating irregular migra-tion of blood/buffer with red background. In this example, the result is positive, as the test line is clearly visible.
C T1 T2
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7372 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
c) Observations on test lines
Ghost test lines White lines on a stained background. In this example, the result is negative, as the test line is not dark and is thus not visible.
Patchy broken test line(s)
The test line is visible but interrupted (broken).
Diffuse test line(s) Test line wider than control, without clearly defined edge.
d) RDT structural problems
Strip misplaced in the cassette
Strip can be seen only partially in the results window.
Specimen pad not seen in sample window
Normally, the colour of the conjugated antibody can be seen in the sample window (commonly purple, pink or blue).
C T1 T2 T3
C T1 T2
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7574 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure AS3.1: How to select of an appropriate RDT
Step 1.1Define setting of use
What? target parasite species and antigena
Pf-only or mixed Pf/non-Pf infections:- HRP2- pLDH-Pf; pLDH-pan
Pf and non-Pf infections (single species)b:- HRP2, aldolase; HRP2, pLDH-pan- HRP2, pLDH-Pv; HRP2, pLDH-Pvom- HRP2, pLDH-pan; pLDH-Pv- pLDH-Pf, pLDH-pan; pLDH-Pf, pLDH-Pv- pLDH-Pf, pLDH-Pvom
P. vivax, only:- aldolase- pLDH-pan- pLDH-Pv
**Pf without HRP2 – Do not use HRP2-based RDTsc
Where? Exposure to high temperature e.g. tropical environment ORtemperature-controlled environment, including during transport and storage
Who? Laboratory personnel ORhealth workers outside laboratories
Step 1.2Review RDT performance
WHO RDT product testing resultsd and apply WHO recommended RDT selection criteriae
- Panel detection score - False-positivity rate - Invalid rate - Ease-of-use- Thermal stability
Sensitivity and specificity based on high-quality field studies in relevant populations
Generate short-list of RDTs
Step 1.3Apply national guidelines and experience in use of RDTs
National malaria treatment guidelines
In-country experience, ease-of-use assessments (Annex 5), availability of training materials
Step 1.4Other considerations
- Price- Manufacturer: production capacity, lead times, heat stability data- Delivery schedules (e.g. staggered deliveries), box size, shelf life- Registration requirements of national regulatory authorities- Product lot testing results- Overall budget requirements (Annex 5)
a Pf-only or mixed Pf/non-Pf infections: Most areas of sub-Saharan Africa and lowland Papua New Guinea; Pf and non-Pf infections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly P. vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere
b Tests with a P. falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed P. falciparum infections. Distinguishing P. falciparum from mixed P. falciparum-vivax infections is important only if a full course of primaquine is routinely given for infections due to P. vivax. This must be weighed against the loss of ability to detect P. malariae and P. ovale if a test has only P. falciparum- and P. vivax-specific lines. Inclusion of further test lines (e.g. Pf-Pv-pan-pLDH) to detect these increases the complexity of test interpretation. A programme should prioritize these various advantages and disadvantages according to local conditions in the initial stage of making procurement decisions.
c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified with high frequency in parts of South America (10). d See references (3–6).e WHO RDT procurement criteria : http://www.who.int/malaria/publications/atoz/rdt_selection_criteria/en/ (accessed 26 June 2014).
For a comprehensive guide to procurement of malaria RDTs extending beyond selection to quantification, budgeting, technical specifications, management of tenders, contracts, supply management and monitoring of supplier performance and managing product variations, see reference (13).
annex s3: selection of an appropriate rdt
an
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7574 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
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n(pL
DH),
F(pL
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n(pL
DH)
F(pL
DH)
55
2020
CA
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30 °C
24
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
F,Ppa
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2P
pan(
pLDH
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55
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CA
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24
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ntag
e Pa
n M
alar
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ard
IR01
3025
Ppa
n(pL
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Ppa
n(pL
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520
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Avan
tage
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Mal
aria
Car
dIR
0160
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24
LAB-
CARE
Dia
gnos
tics
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a) P
VT. L
TD.
ACCU
CARE
ON
E ST
EP M
ALAR
IA P
f/Pan
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igen
Test
MAG
C 25
F,Ppa
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Med
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gnos
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MD
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54
30—
DA
4 -
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24
(con
tinue
d)
7776 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Plas
mod
ium
sp
ecie
s ta
rget
ed
(F =
P. f
alci
paru
m
V =
P. v
ivax
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= P
. ova
le
M =
P. m
alar
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pan;
maj
or
Plas
mod
ium
sp
ecie
s)
Sequ
ence
and
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f w
hole
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Buff
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drop
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L)
Min
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tim
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re
sults
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in)
Max
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adin
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lts
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Prod
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Prem
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orpo
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Firs
t Res
pons
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t Res
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B® M
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f Rap
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nics
Ltd
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rvie
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aria
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lVB
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pan(
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), H
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pan(
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ty) L
tdVi
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iom
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Para
scre
en®
Rapi
d te
st fo
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aria
Pan
/Pf
5031
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pan(
pLDH
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RP2
52
20—
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4 -
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24
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
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0222
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n(pL
DH),
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2P
HRP
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lasm
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2, h
istid
ine
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2 b
Sequ
ence
whe
n te
st h
eld
in a
hor
izon
tal p
ositi
on a
nd th
e sa
mpl
e w
ell i
s at
the
far r
ight
and
con
trol
line
, far
left
c
From
pla
cem
ent o
f buf
fer,
or fr
om ‘i
nter
med
iate
’ ste
p, if
app
licab
led
See
Anne
x 2
e Fo
rmat
s inc
lude
: cas
sett
e (A
); ca
rd (B
); hy
brid
(C),
dips
tick
(D);
or o
ther
(E).
Each
pro
duct
shou
ld id
eally
be
acco
mpa
nied
by
all r
equi
red
mat
eria
ls
(lanc
et, p
ipet
te, e
tc.)
part
icul
arly
whe
n us
ed b
y th
e vi
llage
hea
lth w
orke
r lev
el; h
owev
er, t
his
is o
ften
not
the
case
and
the
cont
ents
dep
end
on th
e re
ques
t of t
he p
rocu
ring
agen
t.
A Ca
sset
teB
Card
C Ca
sset
te h
ybrid
D
Dips
tick
E O
ther
CT
SA
CT
S
C T1 T2C
PP
f
Sam
ple
and
m
ixin
g w
ells
T1CT2
Ann
ex 1
: Cha
ract
eris
tics
of R
DTs
eval
uate
d in
rou
nd 5
(con
tinue
d)
an
ne
Xes
7776 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
annex 2: Malaria rdts: guide to interpretation of results
type a: guide to results of generic pf malaria rdtsResults window: C=control line; T=test line with bound HRP2 or Pf-specific pLDH antibody.
C T
Negative results: One line ‘C’ appears in the results window.
C T
Positive results: P. falciparum infection. Two lines ‘C’ and ‘T’ appear in the results window. Test is positive even if the test line is faint.
C T
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T
C T
7978 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type b: guide to results of generic major Plasmodium species (pan) malaria rdts Results window: C=control line; T=test line with bound pan-specific pLDH or aldolase antibody.
C T
Negative results: One line ‘C’ appears in the results window.
C T
Positive results: Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) infection. Two lines ‘C’ and ‘T’ appear in the results window. Test is positive even is the test line is faint.
C T
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T
C T
an
ne
Xes
7978 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type c: guide to results of generic pan-pf malaria rdtsResults window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound HRP2
and/or Pf-specific pLDH antibody.
C T2T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2
Positive results:
P. falciparum: Two lines ‘C’ and ‘T2” appear in the results window.
C T1 T2
Non-falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection: Two lines ‘C’ and ‘T1” appear in the results window.
C T1 T2
P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
8180 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type d: guide to results of generic pf-pan malaria rdtsResults window: C=control line; T1=test line with bound HRP2 or Pf-specific LDH antibody;
T2=test line with bound pLDH or aldolase antibody.
C T2T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2
Non-falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2
P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
an
ne
Xes
8180 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type e: guide to results of generic pv-pf malaria rdtsResults window: C=control line; T1=test line with bound P. vivax-specific pLDH;
T2=test line with bound HRP2 or Pf-specific pLDH antibody.
C T2T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2
P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2
P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
8382 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type f: guide to results of generic pf-pv malaria rdtsResults window: C=control line; T1= test line with bound HRP2 or Pf-specific pLDH antibody;
T2=test line with bound P. vivax-specific pLDH.
C T2T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2
P. vivax infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2
P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
an
ne
Xes
8382 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type g: guide to results of generic pan-pv-pf malaria rdtsResults window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound P. vivax-specific
pLDH; T3=test line with bound HRP2 or Pf-specific pLDH antibody
C T2 T3T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2 T3
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. vivax infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2 T3
P. falciparum with or without mixed infection with P. ovale or P. malariae. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. falciparum and P. vivax mixed infection with or without P. ovale and/or P. malariae infection. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.
C T1 T2 T3
8584 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
P. vivax with or without P. ovale and/or P. malariae infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2 T3
P. malariae with or without P. ovale and/or P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2 T3
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
an
ne
Xes
8584 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type H: guide to results of generic vom1-pf malaria rdtsResults window: C=control line; T1= test line with bound pLDH specific for non-P. falciparum (P. vivax, P. ovale and P. malariae);
T2=test line with bound HRP2 or Pf-specific pLDH antibody
C T2T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2
P. falciparum mixed infection (with P. vivax, P. ovale and/or P. malariae). Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2
Non-P. falciparum infection (P. vivax, P. ovale and P. malariae) or mixed infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
1 vom, P. vivax, P. ovale, P. malariae
8786 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type i: guide to results of generic pv malaria rdts Results window: C=control line; T=test line with bound P. vivax-specific pLDH.
C T
Negative results: Only one line ‘C’ appears in the results window.
C T
Positive results: P. vivax infection. Two lines ‘C’ and ‘T’ appear in the results window.
C T
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T
C T
an
ne
Xes
8786 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type j: guide to results of generic pf-pf malaria rdtsResults window: C=control line; T1= test line with bound pLDH specific for P. falciparum;
T2=test line with bound HRP2.
C T2T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2
P. falciparum infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
8988 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type k: guide to results of generic pv-pf-pf malaria rdtsResults window: C=control line; T1= test line with bound P. vivax-specific pLDH; T2=test line with bound HRP2 or Pf-specific
pLDH antibody; T3=test line with bound HRP2 or Pf-specific pLDH antibody. If an RDT has bound HRP2 antibodies on T2, T3 will have bound Pf-specific pLDH and vice versa (T2 Pf antigen target ≠ T3 Pf antigen target).
C T2 T3T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2 T3
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2 T3
P. falciparum infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. falciparum infection and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2 T3
P. falciparum infection and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.
C T1 T2 T3
an
ne
Xes
8988 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
P. falciparum infection and P. vivax mixed infection. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2 T3
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
9190 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
type l: guide to results of generic pan-pf-pf malaria rdtsResults window: C=control line; T1= test line with bound PAN-pLDH or aldolase antibody; T2=test line with bound HRP2 or
Pf-specific pLDH antibody; T3=test line with bound HRP2 or Pf-specific pLDH antibody. If an RDT has bound HRP2 antibodies on T2, T3 will have bound Pf-specific pLDH and vice versa (T2 Pf antigen target ≠ T3 Pf antigen target)
C T2 T3T1
Negative results: Only one line ‘C’ appears in the results window.
C T1 T2 T3
Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.
C T1 T2 T3
P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. falciparum infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window.
C T1 T2 T3
P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.
C T1 T2 T3
P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.
C T1 T2 T3
an
ne
Xes
9190 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.
C T1 T2 T3
Non-P. falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection. Two lines ‘C’ and ‘T1’ appear in the results window.
C T1 T2 T3
Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
C T1 T2 T3
9392 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
anne
x 3:
pha
se-1
res
ults
Tabl
eA3.
1: L
ot v
aria
bilit
y in
pos
itive
res
ults
a ag
ains
t ph
ase-
1 P.
fal
cipa
rum
cul
ture
sam
ples
at
low
(200
) an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/μL)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=20)
Tota
l pos
itive
res
ults
ret
urne
d
200
para
sites
/μL
2000
par
asite
s/μL
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
b (m
ax=2
0)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsb
(max
=20)
Test
1Te
st 2
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
t IT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.19
.019
.019
.020
.019
.019
.020
.020
.0
Avan
tage
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Mal
aria
Car
dIR
0160
25J.
Mitr
a &
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. Ltd
.20
.019
.019
.020
.018
.018
.020
.020
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Care
Star
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.20
.020
.020
.020
.020
.020
.020
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diag
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sett
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A Di
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Sys
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.020
.020
.020
.020
.020
.020
.020
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Firs
t Res
pons
e® M
alar
ia A
g P.
falc
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um (H
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Prem
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n20
.020
.020
.020
.020
.020
.020
.020
.0
IMM
UN
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MAL
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falc
ipar
um
0502
_K25
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19
.019
.019
.019
.019
.019
.020
.020
.0
KHB®
Mal
aria
Ag
P.f R
apid
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tKH
-R-0
6-20
Sh
angh
ai K
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-eng
inee
ring
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td.
20.0
20.0
20.0
20.0
19.0
19.0
19.0
(19)
19.0
(19)
SD B
IOLI
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Mal
aria
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Pf
05FK
50/0
5FK5
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anda
rd D
iagn
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s In
c.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Visi
on M
alar
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f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Pf a
nd p
anAC
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NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
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gnos
tics
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a) P
VT. L
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20.0
17.0
(19)
17.0
(19)
20.0
18.0
(19)
18.0
(19)
20.0
20.0
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
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c Pr
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nc.
20.0
20.0
20.0
20.0
19.0
19.0
19.0
(19)
20.0
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
12.0
9.0
7.0
7.0
4.0
0.0
20.0
20.0
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
20.0
18.0
18.0
20.0
20.0
20.0
20.0
20.0
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REDI
T M
alar
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g Pf
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.020
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.020
.020
.020
.020
.020
.0
BioT
race
r™ M
alar
ia P
f/PA
N R
apid
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d17
012
Bio
Focu
s Co
., Lt
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.020
.020
.020
.020
.020
.020
.020
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Care
Star
t™ M
alar
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pLDH
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20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Clea
rvie
w®
Mal
aria
Dua
lVB
20Or
geni
cs L
td.(I
S)20
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.020
.020
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ms
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.019
.019
.020
.019
.020
.020
.0
Firs
t Res
pons
e® M
alar
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g. p
LDH
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Car
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stI1
6FRC
Prem
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edic
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n19
.020
.019
.020
.019
.019
.020
.020
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Body
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f/Pa
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c.20
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.019
.020
.019
.019
.020
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alar
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n Ag
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id T
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20-0
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01G
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orp.
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20.0
19.0
19.0
18.0
19.0
18.0
20.0
20.0
Hum
asis
Mal
aria
Pf/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
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ION
AL20
.019
.019
.020
.020
.020
.019
.020
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Mal
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Pf./
Pan
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AL P
f/Pa
n) T
est K
itA0
3-18
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Artr
on L
abor
ator
ies
Inc.
17.0
16.0
15.0
15.0
13.0
12.0
20.0
20.0
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
20.0
19.0
(19)
19.0
(19)
19.0
(19)
19.0
(19)
18.0
(18)
20.0
20.0
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, IN
C.12
.013
.07.
015
.07.
04.
020
.020
.0
MD
Mal
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Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
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SARL
NG
Bio
tech
, Z.A
.20
.020
.020
.019
.0 (1
9)20
.019
.0 (1
9)20
.020
.0
an
ne
Xes
9392 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=20)
Tota
l pos
itive
res
ults
ret
urne
d
200
para
sites
/μL
2000
par
asite
s/μL
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
b (m
ax=2
0)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsb
(max
=20)
Test
1Te
st 2
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h In
c.20
.020
.020
.020
.020
.020
.020
.020
.0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
19.0
20.0
19.0
20.0
20.0
20.0
20.0
20.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
20.0
19.0
19.0
19.0
20.0
19.0
20.0
20.0
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
19.0
18.0
(19)
18.0
(19)
20.0
18.0
(19)
18.0
(19)
20.0
19.0
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.20
.019
.019
.020
.020
.020
.020
.020
.0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.20
.019
.019
.020
.020
.020
.020
.020
.0
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um a
nd P.
viv
ax M
alar
ia -
Devi
ce55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
19.0
20.0
19.0
19.0
19.0
19.0
20.0
20.0
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.20
.020
.020
.020
.019
.019
.020
.020
.0
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
19.0
16.0
15.0
18.0
18.0
17.0
20.0
20.0
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
19.0
20.0
19.0
20.0
20.0
20.0
20.0
20.0
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
s P
vom
, Pla
smod
ium
viv
ax, o
vale
and
mal
aria
ea
Resu
lts a
re b
ased
on
the
first
read
er’s
inte
rpre
tatio
n ac
cord
ing
to th
e m
anuf
actu
rer’s
inst
ruct
ions
.b
Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.
Tabl
e A
3.1
(con
tinue
d)
9594 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
3.2:
Dis
trib
utio
n of
tes
t ba
nd in
tens
ity
(0-4
) sc
ores
aga
inst
pha
se-1
P. f
alci
paru
m c
ultu
red
para
site
s at
low
(200
) an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/μL)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μL
2000
par
asite
s/μL
200
para
sites
/μL
2000
par
asite
s/μL
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=40)
Perc
enta
ge d
istrib
utio
n of
pan
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
pan
te
st b
and
inte
nsity
b (n
=40)
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf o
nly
Adva
nced
Qua
lity™
One
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p M
alar
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P110
02TC
1/TC
40In
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Prod
ucts
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.3.
857
.533
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00.
00.
02.
527
.542
.527
.5N
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AN
AN
AN
AN
AN
AN
AN
AN
A
Avan
tage
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Mal
aria
Car
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Mitr
a &
Co.
Pvt
. Ltd
.3.
817
.560
.016
.32.
50.
00.
05.
025
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AN
AN
AN
AN
AN
AN
AN
AN
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Care
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07.
541
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80.
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02.
55.
092
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AN
AN
AN
AN
AN
AN
AN
AN
A
diag
nost
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alar
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f)Cas
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BKM
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05.
033
.845
.016
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00.
00.
05.
095
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AN
AN
AN
AN
AN
AN
A
First
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pons
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g P.
falci
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Car
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Prem
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06.
333
.843
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00.
05.
095
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AN
AN
AN
AN
AN
AN
AN
AN
A
IMM
UN
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MAL
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falc
ipar
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0502
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BIOS
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028
.857
.58.
80.
00.
00.
015
.065
.020
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
1.3
12.5
45.0
30.0
11.3
0.0
0.0
2.5
7.5
90.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
3St
anda
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s In
c.
0.0
3.8
22.5
63.8
10.0
0.0
0.0
0.0
5.0
95.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Visi
on M
alar
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f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
0.0
10.0
46.3
35.0
8.8
0.0
0.0
2.5
7.5
90.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics (
Indi
a) P
VT. L
TD.
6.3
15.0
58.8
16.3
3.8
0.0
0.0
7.5
32.5
60.0
52.5
42.5
5.0
0.0
0.0
5.0
40.0
55.0
0.0
0.0
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
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ts, I
nc.
1.3
26.3
43.8
25.0
3.8
2.5
0.0
7.5
22.5
67.5
58.8
41.3
0.0
0.0
0.0
2.5
32.5
57.5
7.5
0.0
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
60.0
40.0
0.0
0.0
0.0
0.0
25.0
75.0
0.0
0.0
95.0
5.0
0.0
0.0
0.0
0.0
72.5
27.5
0.0
0.0
Adva
ntag
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alar
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an +
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ard
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1025
J. M
itra
& C
o. P
vt. L
td.
2.5
32.5
57.5
7.5
0.0
0.0
0.0
5.0
32.5
62.5
10.0
87.5
2.5
0.0
0.0
0.0
0.0
52.5
47.5
0.0
BIOC
REDI
T M
alar
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g Pf
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538
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00.
00.
02.
57.
590
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00.
00.
012
.570
.017
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0
BioT
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apid
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023
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00.
00.
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017
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00.
00.
00.
062
.537
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00.
0
Care
Star
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alar
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RP2/
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Acce
ss B
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0.0
8.8
42.5
37.5
11.3
0.0
0.0
2.5
5.0
92.5
12.5
85.0
2.5
0.0
0.0
0.0
0.0
67.5
32.5
0.0
Clea
rvie
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td.(I
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330
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filia
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First
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f/Pa
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td.
3.8
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50.0
31.3
10.0
0.0
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2.5
17.5
80.0
67.5
32.5
0.0
0.0
0.0
0.0
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040
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030
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0
Para
scre
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st fo
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0.0
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42.5
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42.5
47.5
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78.8
21.3
0.0
0.0
0.0
20.0
80.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
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Ant
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Pf/
Pan
05FK
60/0
5FK6
3St
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s In
c.
0.0
2.5
27.5
56.3
13.8
0.0
0.0
0.0
5.0
95.0
57.5
42.5
0.0
0.0
0.0
0.0
5.0
60.0
35.0
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Viki
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alar
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g Pf
/Pan
4124
99IM
ACCE
SS S
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2.5
27.5
52.5
16.3
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0.0
10.0
27.5
62.5
100.
00.
00.
00.
00.
010
.087
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50.
00.
0
an
ne
Xes
9594 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μL
2000
par
asite
s/μL
200
para
sites
/μL
2000
par
asite
s/μL
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
Pf
te
st b
and
inte
nsity
b (n
=40)
Perc
enta
ge d
istrib
utio
n of
pan
te
st b
and
inte
nsity
b (n
=80)
Perc
enta
ge d
istrib
utio
n of
pan
te
st b
and
inte
nsity
b (n
=40)
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
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o., L
td
0.0
13.8
50.0
28.8
7.5
0.0
0.0
5.0
15.0
80.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf (
HRPI
I)/ P
V (P
LDH)
Ant
igen
Det
ectio
n Te
st D
evice
G
M00
6Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt. L
td.
6.3
3.8
43.8
40.0
6.3
2.5
0.0
2.5
0.0
95.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
erisc
an®
Mal
aria
Pf/P
AN (P
v, Pm
, Po)
3 Li
ne A
ntig
en Te
stM
AT-P
F/PA
N-50
Bhat
Bio
-Tec
h In
dia
(P) L
td.
1.3
16.3
66.3
15.0
1.3
0.0
0.0
0.0
60.0
40.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical (
Beiji
ng) C
o., L
td.
1.3
1.3
40.0
48.8
8.8
0.0
0.0
2.5
5.0
92.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT
®fV
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
. viv
ax
Mal
aria
- D
evic
e55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
3.8
42.5
47.5
6.3
0.0
0.0
0.0
10.0
45.0
45.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.1.
38.
842
.541
.36.
30.
00.
02.
510
.087
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
11.3
85.0
3.8
0.0
0.0
0.0
0.0
50.0
47.5
2.5
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
1.3
95.0
3.8
0.0
0.0
0.0
0.0
37.5
55.0
7.5
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
a De
note
s no
ban
d vi
sibl
e b
Calc
ulat
ions
incl
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inva
lid te
sts
Tabl
e A
3.2
(con
tinue
d)
9796 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
anne
x 4:
pha
se-2
res
ults
Tabl
e A
4.1:
Lot
var
iatio
n in
pos
itive
res
ults
aga
inst
pha
se-2
wild
-typ
e P.
fal
cipa
rum
and
P. v
ivax
sam
ples
at
low
(200
) an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/μL)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
P. f
alci
paru
m s
ampl
es (n
=100
)P.
viv
ax s
ampl
es (n
=35)
Tota
l pos
itive
res
ults
a re
turn
edTo
tal p
ositi
ve r
esul
tsa
retu
rned
200
para
sites
/μL
2000
b
para
sites
/μL
200
para
sites
/μL
2000
b
para
sites
/μL
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=3
5)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=35)
Test
1Te
st 2
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
t IT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.70
.0 (9
9)63
.059
.0 (9
9)85
.083
.073
.093
.099
.0 (9
9)N
AN
AN
AN
AN
AN
AN
AN
A
Adva
ntag
e P.
f Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.92
.095
.092
.094
.094
.093
.099
.010
0.0
NA
NA
NA
NA
NA
NA
NA
NA
Care
Star
t™M
alar
ia H
RP2
(Pf)
G01
41Ac
cess
Bio
. Inc
.96
.094
.093
.096
.098
.095
.010
0.0
100.
0N
AN
AN
AN
AN
AN
AN
AN
A
diag
nost
icks
- M
alar
ia (P
f)Cas
sett
e W
BKM
FC60
01SS
A Di
agno
stics
& B
iote
ch Sy
stem
s93
.0 (9
9)96
.0 (1
00)
91.0
(99)
95.0
94.0
93.0
99.0
(99)
99.0
(99)
NA
NA
NA
NA
NA
NA
NA
NA
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Ca
rd T
est
I13F
RCPr
emie
r Med
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Cor
pora
tion
97.0
99.0
97.0
97.0
96.0
95.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
NA
NA
IMM
UN
OQU
ICK®
MAL
ARIA
falc
ipar
um
0502
_K25
BIOS
YNEX
82
.081
.075
.089
.0 (9
9)86
.084
.0 (9
9)93
.010
0.0
NA
NA
NA
NA
NA
NA
NA
NA
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
90.0
84.0
83.0
97.0
92.0
91.0
89.0
(95)
95.0
(97)
NA
NA
NA
NA
NA
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
3St
anda
rd D
iagn
ostic
s In
c.
96.0
96.0
96.0
99.0
98.0
97.0
100.
099
.0N
AN
AN
AN
AN
AN
AN
AN
A
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
92.0
93.0
89.0
95.0
92.0
90.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd p
an
ACCU
CARE
ONE
STE
P M
ALAR
IA P
f/Pan
Ant
igen
Test
MAG
C 25
LAB-
CARE
Dia
gnos
tics
(Indi
a)
PVT.
LTD.
79.0
77.0
72.0
80.0
79.0
75.0
97.0
94.0
(99)
23.0
(34)
27.0
17.0
(34)
29.0
24.0
23.0
35.0
34.0
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
91.0
(96)
87.0
(94)
81.0
(90)
96.0
(99)
98.0
95.0
(99)
97.0
(97)
100.
028
.0 (3
4)23
.0 (3
1)21
.0 (3
0)34
.031
.0 (3
4)31
.0 (3
4)34
.035
.0
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
48.0
50.0
42.0
43.0
44.0
35.0
96.0
95.0
35.0
35.0
35.0
35.0
33.0
33.0
34.0
35.0
Adva
ntag
e M
alar
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an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
91.0
92.0
87.0
90.0
91.0
87.0
100.
010
0.0
35.0
35.0
35.0
35.0
35.0
35.0
35.0
34.0
(34)
BIOC
REDI
T M
alar
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g Pf
/Pan
(HRP
II/pL
DH)
C30R
HA2
5Ra
piG
EN IN
C.82
.082
.079
.081
.082
.079
.098
.0 (9
8)99
.033
.031
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.032
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.029
.034
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.0
BioT
race
r™ M
alar
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f/PA
N R
apid
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012
Bio
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s Co
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d.84
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.0
Care
Star
t™ M
alar
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RP2/
pLDH
(Pf/P
AN) C
ombo
G01
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.94
.093
.091
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.097
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0.0
100.
034
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Clea
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geni
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td.(I
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.095
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99.0
26.0
30.0
24.0
28.0
32.0
27.0
32.0
33.0
DIAQ
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4)32
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EzDx
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0.0
100.
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Firs
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pora
tion
89.0
91.0
87.0
90.0
88.0
86.0
100.
010
0.0
32.0
31.0
29.0
32.0
34.0
31.0
35.0
35.0
Gen
Body
™M
alar
ia P
f/Pa
n Ag
MAL
AG10
0G
enBo
dy In
c.87
.091
.085
.094
.090
.089
.010
0.0
100.
029
.024
.021
.027
.028
.023
.035
.031
.0
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01G
reen
Cro
ss M
edic
al S
cien
ce
Corp
. (Ko
rea)
76.0
72.0
70.0
78.0
79.0
77.0
98.0
98.0
14.0
10.0
8.0
10.0
12.0
6.0
33.0
32.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
95.0
(99)
94.0
92.0
(99)
91.0
(98)
93.0
(99)
88.0
(97)
100.
099
.0 (9
9)35
.033
.0 (3
4)33
.0 (3
4)35
.032
.0 (3
4)32
.0 (3
4)34
.035
.0
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL99
.099
.098
.097
.096
.094
.098
.010
0.0
26.0
23.0
17.0
29.0
31.0
26.0
33.0
35.0
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n) T
est K
itA0
3-18
-322
Artr
on L
abor
ator
ies
Inc.
74.0
(99)
69.0
65.0
(99)
68.0
66.0
(99)
64.0
(99)
98.0
94.0
(99)
8.0
7.0
4.0
2.0
3.0
2.0
35.0
34.0
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
92.0
91.0
(98)
88.0
(98)
97.0
96.0
95.0
100.
099
.0 (9
9)34
.0 (3
4)33
.0 (3
4)32
.0 (3
3)35
.033
.033
.034
.0 (3
4)35
.0
an
ne
Xes
9796 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
P. f
alci
paru
m s
ampl
es (n
=100
)P.
viv
ax s
ampl
es (n
=35)
Tota
l pos
itive
res
ults
a re
turn
edTo
tal p
ositi
ve r
esul
tsa
retu
rned
200
para
sites
/μL
2000
b
para
sites
/μL
200
para
sites
/μL
2000
b
para
sites
/μL
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=1
00)
Test
1Te
st 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=3
5)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=35)
Test
1Te
st 2
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, IN
C.76
.075
.065
.068
.070
.054
.099
.098
.014
.018
.09.
023
.015
.011
.023
.022
.0
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH0
01M
edic
al D
iagn
oste
ch (P
ty) L
td98
.099
.097
.099
.096
.096
.010
0.0
100.
016
.019
.014
.025
.026
.019
.019
.023
.0
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
-MAL
- W
23-0
01SA
RL N
G B
iote
ch, Z
.A.
94.0
95.0
93.0
97.0
94.0
(99)
93.0
(99)
100.
010
0.0
33.0
35.0
33.0
31.0
25.0
23.0
34.0
33.0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h In
c.90
.088
.0 (9
9)88
.0 (9
9)92
.091
.088
.010
0.0
100.
034
.035
.034
.033
.034
.032
.035
.034
.0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
95.0
95.0
94.0
96.0
98.0
96.0
99.0
(99)
100.
024
.024
.019
.028
.024
.022
.034
.035
.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Test
Cas
sett
eIM
PN-C
52Ha
ngzh
ou B
iote
st B
iote
ch C
o. Lt
d.84
.078
.076
.093
.088
.087
.094
.010
0.0
24.0
21.0
17.0
25.0
25.0
21.0
31.0
35.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/
05FK
63St
anda
rd D
iagn
ostic
s In
c.
97.0
96.0
95.0
98.0
96.0
95.0
100.
099
.033
.034
.032
.035
.034
.034
.035
.034
.0
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
89.0
89.0
86.0
91.0
88.0
87.0
97.0
(99)
99.0
8.0
(34)
10.0
5.0
(34)
6.0
6.0
3.0
33.0
(34)
34.0
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
91.0
89.0
86.0
87.0
86.0
84.0
100.
099
.029
.028
.024
.023
.022
.017
.035
.035
.0
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
De
tect
ion
Test
Dev
ice
GM
006
Gen
omix
Mol
ecul
ar D
iagn
ostic
s Pv
t. Lt
d.89
.0 (9
4)92
.085
.0 (9
4)92
.0 (9
9)94
.0 (9
8)90
.0 (9
7)93
.0 (9
6)99
.0 (9
9)32
.034
.031
.030
.0 (3
3)33
.028
.0 (3
3)34
.034
.0
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.91
.0 (9
9)94
.086
.0 (9
9)95
.098
.094
.099
.0 (9
9)10
0.0
27.0
(34)
29.0
25.0
(34)
30.0
33.0
29.0
34.0
(34)
35.0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co
., Lt
d.98
.095
.095
.098
.097
.096
.010
0.0
100.
035
.035
.035
.035
.035
.035
.035
.035
.0
Para
HIT
®fV
Rapi
d te
st fo
r P. f
alci
paru
m a
nd
P. v
ivax
Mal
aria
- D
evic
e55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
70.0
(99)
73.0
63.0
(99)
83.0
81.0
80.0
91.0
100.
023
.023
.020
.024
.026
.020
.030
.035
.0
Won
dfo®
One
Ste
p M
alar
ia P.
f/P.v
Who
le B
lood
Test
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.94
.090
.089
.094
.094
.0 (9
9)90
.0 (9
9)10
0.0
98.0
28.0
16.0
14.0
26.0
21.0
17.0
35.0
34.0
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
88.0
82.0
82.0
87.0
80.0
78.0
98.0
98.0
35.0
35.0
35.0
35.0
35.0
35.0
35.0
35.0
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
91.0
91.0
85.0
96.0
93.0
92.0
99.0
99.0
35.0
35.0
35.0
35.0
31.0
31.0
35.0
34.0
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
a Re
sults
are
bas
ed o
n th
e fir
st re
ader
’s in
terp
reta
tion
acco
rdin
g to
the
man
ufac
ture
r’s in
stru
ctio
ns.
b 4
(4%
) of t
he 1
00 P
. fal
cipa
rum
dilu
tion
sam
ples
set
s ha
d 20
0 an
d 50
00 p
aras
ites/
μL a
nd 2
(6%
) of t
he 3
5 P.
viv
ax d
ilutio
n sa
mpl
e se
ts h
ad 2
00 a
nd 5
000
para
site
s/μL
c
Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.
Tabl
e A
4.1
(con
tinue
d)
9998 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.2:
Dis
trib
utio
n of
tes
t ba
nd in
tens
ity
(0-4
) sc
ores
aga
inst
pha
se-2
wild
-typ
e P.
fal
cipa
rum
sam
ples
at
low
(200
) an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/μL)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
200
para
sites
/μL
2000
b pa
rasit
es/μ
L20
0 pa
rasit
es/μ
L20
00b
para
sites
/μL
200
para
sites
/μL
2000
b pa
rasit
es/μ
LPe
rcen
tage
dist
ribut
ion
of P
f te
st b
and
inte
nsity
c (n
=400
)
Perc
enta
ge d
istrib
utio
n of
Pf
test
ban
d in
tens
ityc
(n=2
00)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=400
)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=200
)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=4
00)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=2
00)
0a1
23
40a
12
34
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia
Pf T
est
ITP1
1002
TC1/
TC40
InTe
c Pr
oduc
ts, I
nc.
24.5
46.8
24.8
3.8
0.3
4.0
13.0
29.0
31.0
23.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Adva
ntag
e P.
f Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.6.
327
.342
.318
.36.
00.
52.
511
.017
.069
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Care
Star
t™M
alar
ia H
RP2
(Pf)
G01
41Ac
cess
Bio
. Inc
.4.
018
.032
.531
.314
.30.
01.
04.
019
.076
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
diag
nost
icks
- Mal
aria
(Pf)C
asse
tte
WB
KMFC
6001
SSA
Diag
nost
ics
&
Biot
ech
Syst
ems
5.3
14.8
26.0
28.0
26.0
1.0
0.0
2.0
10.0
87.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
First
Res
pons
e® M
alar
ia A
g P.
falci
paru
m
(HRP
2) C
ard
Test
I13F
RCPr
emie
r Med
ical
Co
rpor
atio
n2.
813
.528
.533
.322
.00.
00.
52.
015
.082
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
IMM
UNOQ
UICK
® M
ALAR
IA fa
lcip
arum
050
2_K2
5BI
OSYN
EX
15.5
33.0
37.5
13.3
0.8
3.5
4.5
17.5
37.0
37.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-en
gine
erin
g Co
.,Ltd
.9.
322
.333
.522
.312
.84.
00.
57.
514
.074
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
3St
anda
rd D
iagn
ostic
s Inc
. 2.
810
.526
.336
.823
.80.
50.
03.
512
.084
.0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
7.0
19.0
35.5
28.8
9.8
0.0
0.5
6.5
18.5
74.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/P
an
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics
(Indi
a) P
VT. L
TD.
21.3
34.8
34.0
10.0
0.0
4.5
5.5
22.0
36.0
32.0
81.0
15.5
3.5
0.0
0.0
21.5
46.0
31.0
1.5
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Adva
nced
Qua
lity™
Rap
id M
alar
ia
Test
(Pf/
Pan)
IT
P110
05In
Tec
Prod
ucts
, Inc
.7.
034
.342
.314
.32.
31.
52.
511
.533
.551
.070
.029
.50.
50.
00.
09.
042
.544
.54.
00.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
53.8
44.8
1.5
0.0
0.0
4.5
26.5
50.0
18.5
0.5
69.3
30.8
0.0
0.0
0.0
5.5
42.5
47.5
4.5
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
9.0
32.3
43.0
13.3
2.5
0.0
1.5
14.0
20.5
64.0
12.3
62.8
25.0
0.0
0.0
2.0
2.0
42.5
43.5
10.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
BIOC
REDI
T Mala
ria A
g Pf/P
an (H
RPII/
pLDH
)C3
0RH
A25
Rapi
GEN
INC.
18.3
12.8
31.5
29.0
8.5
1.5
2.0
9.5
23.5
63.5
78.5
20.5
1.0
0.0
0.0
15.0
21.0
51.0
12.0
1.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
BioT
race
r™ M
alar
ia P
f/PAN
Rap
id C
ard
1701
2Bi
o Fo
cus
Co.,
Ltd.
14.0
24.5
40.5
19.3
1.8
3.0
2.0
13.0
24.0
58.0
78.0
21.8
0.3
0.0
0.0
9.5
41.0
49.0
0.5
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(P
f/PA
N) C
ombo
G01
31Ac
cess
Bio
. Inc
.5.
514
.031
.523
.525
.50.
00.
52.
012
.085
.521
.066
.312
.80.
00.
01.
08.
549
.033
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AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Clea
rvie
w®
Mal
aria
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lVB
20Or
geni
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td.(I
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517
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050
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AN
AN
AN
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AN
AN
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A
DIAQ
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K M
alar
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sset
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511
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50.
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04.
524
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AN
AN
AN
AN
AN
AN
AN
AN
AN
A
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est
Dete
ctio
n Ki
tRK
MAL
001
Adv
y C
hem
ical
Pvt
. Lt
d. (A
ffili
ate
of B
hara
t Se
rum
s & V
acci
nes L
td. )
13.3
21.3
39.3
22.8
3.5
0.0
2.0
13.0
19.0
66.0
74.5
25.3
0.3
0.0
0.0
7.0
33.5
51.0
8.0
0.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH/
HRP2
Co
mbo
Car
d Te
stI1
6FRC
Prem
ier M
edic
al
Corp
orat
ion
10.5
21.0
34.8
24.3
9.5
0.0
1.0
7.0
14.0
78.0
69.0
29.8
1.3
0.0
0.0
3.0
36.0
53.0
7.5
0.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Gen
Body
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alar
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f/Pa
n Ag
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c.9.
526
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00.
02.
012
.026
.060
.086
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.01.
50.
00.
015
.543
.539
.02.
00.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Gene
dia®
Mal
aria
P.f/
Pan
Ag R
apid
Test
20-
0146
-01
Gre
en C
ross
Med
ical
Sc
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rp. (
Kore
a)23
.821
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82.
04.
010
.511
.572
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81.
00.
00.
043
.028
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50.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Hum
asis
Mal
aria
Pf/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
6.8
17.3
38.8
30.8
6.5
0.5
0.5
4.5
23.5
71.0
62.5
36.5
0.8
0.3
0.0
3.0
29.5
56.5
10.5
0.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL2.
317
.835
.328
.316
.51.
00.
56.
516
.076
.062
.530
.55.
81.
30.
04.
523
.548
.023
.50.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n)
Test
Kit
A03-
18-3
22Ar
tron
Lab
orat
orie
s In
c.30
.838
.326
.04.
80.
34.
012
.520
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.529
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.50.
30.
08.
518
.539
.531
.52.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
5.8
18.3
43.8
27.5
4.8
0.5
0.0
10.0
25.5
64.0
62.0
37.3
0.8
0.0
0.0
2.5
28.0
58.5
11.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Test
Dev
iceM
FV-1
24AZ
OG, I
NC.
27.8
69.3
3.0
0.0
0.0
1.5
26.5
48.5
21.0
2.5
7.8
91.0
1.3
0.0
0.0
6.0
89.5
4.0
0.5
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
an
ne
Xes
9998 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
200
para
sites
/μL
2000
b pa
rasit
es/μ
L20
0 pa
rasit
es/μ
L20
00b
para
sites
/μL
200
para
sites
/μL
2000
b pa
rasit
es/μ
LPe
rcen
tage
dist
ribut
ion
of P
f te
st b
and
inte
nsity
c (n
=400
)
Perc
enta
ge d
istrib
utio
n of
Pf
test
ban
d in
tens
ityc
(n=2
00)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=400
)
Perc
enta
ge d
istrib
utio
n of
pa
n te
st b
and
inte
nsity
c (n
=200
)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=4
00)
Perc
enta
ge d
istrib
utio
n of
Pv
test
ban
d in
tens
ityc
(n=2
00)
0a1
23
40a
12
34
0a1
23
40a
12
34
0a1
23
40a
12
34
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(P
ty) L
td2.
016
.336
.034
.311
.50.
00.
06.
023
.570
.528
.356
.814
.30.
80.
02.
57.
550
.037
.03.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG-M
AL-W
23-0
01SA
RL N
G B
iote
ch, Z
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5.0
21.8
35.5
29.3
8.5
0.0
0.0
7.0
29.0
64.0
38.0
50.3
10.5
1.3
0.0
2.5
15.5
46.5
32.0
3.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h In
c.9.
822
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00.
02.
59.
526
.561
.568
.331
.00.
50.
30.
04.
031
.052
.512
.00.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan/
Pf50
3100
25Ze
phyr
Bio
med
ical
s4.
018
.534
.026
.816
.80.
50.
06.
09.
084
.567
.332
.50.
30.
00.
06.
536
.045
.012
.00.
5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Test
Ca
sset
teIM
PN-C
52H
angz
hou
Biot
est
Biot
ech
Co. L
td.
14.3
26.5
48.0
10.5
0.8
3.0
2.5
17.5
41.5
35.5
84.8
14.8
0.0
0.5
0.0
24.5
66.5
9.0
0.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s Inc
. 3.
312
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.30.
50.
55.
013
.580
.536
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.310
.50.
30.
02.
09.
046
.533
.59.
0N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
10.8
23.5
47.3
17.8
0.8
2.0
3.0
12.0
32.5
50.5
82.8
15.0
2.3
0.0
0.0
11.0
52.0
34.0
3.0
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd P
v/Pv
om
ASAN
Eas
y Te
st®
Mal
aria
Pf/
Pan
AgAM
4650
-KAS
AN P
harm
aceu
tical
Co
., Lt
d 11
.828
.337
.020
.82.
30.
53.
012
.026
.058
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A83
.515
.51.
00.
00.
014
.547
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.54.
00.
0
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) An
tigen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Di
agno
stic
s Pv
t. Lt
d.8.
320
.338
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04.
01.
09.
020
.565
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AN
AN
AN
AN
AN
AN
AN
AN
AN
A98
.51.
30.
30.
00.
096
.53.
00.
50.
00.
0
Mal
erisc
an®
Mal
aria
Pf/P
AN (P
v, Pm
, Po)
3
Line
Ant
igen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.5.
522
.046
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.04.
00.
00.
013
.542
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AN
AN
AN
AN
AN
AN
AN
AN
AN
A72
.825
.81.
50.
00.
013
.058
.528
.00.
50.
0
One
Step
Mal
aria
P.F
/P.V
Tes
t (C
asse
tte)
5233
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
3.0
17.5
41.3
27.8
10.5
0.0
0.0
8.0
20.0
72.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
78.5
19.0
2.5
0.0
0.0
91.0
8.0
1.0
0.0
0.0
Para
HIT®
fV R
apid
test
for P
. fal
cipa
rum
an
d P.
viv
ax M
alar
ia -
Dev
ice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.23
.326
.838
.011
.01.
04.
55.
021
.526
.542
.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A98
.01.
30.
30.
00.
599
.50.
00.
00.
50.
0
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.7.
015
.035
.527
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.81.
00.
57.
012
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.5N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A98
.51.
50.
00.
00.
098
.51.
00.
00.
00.
5
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
15.8
61.8
22.5
0.0
0.0
2.0
1.5
43.5
44.0
9.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
7.3
64.3
28.0
0.5
0.0
1.0
2.0
25.0
43.5
28.5
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
a De
note
s no
vis
ible
ban
d b
4 (4
%) o
f the
100
P. f
alci
paru
m d
ilutio
n sa
mpl
es s
ets
had
200
and
5000
par
asite
s/μL
and
2 (6
%) o
f the
35
P. v
ivax
dilu
tion
sam
ple
sets
had
200
and
500
0 pa
rasi
tes/
μL
c Ca
lcul
atio
ns in
clud
e in
valid
test
s
Tabl
e A
4.2
(con
tinue
d)
101100 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.3:
Dis
trib
utio
n of
pan
/Pv
test
ban
d in
tens
ity
(0-4
) sc
ores
for
pha
se-2
wild
-typ
e P.
viv
ax s
ampl
es a
t lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μL
2000
b pa
rasit
es/μ
L20
0 pa
rasit
es/μ
L20
00b
para
sites
/μL
Perc
enta
ge d
istrib
utio
n of
pan
te
st b
and
inte
nsity
e (n
=140
)Pe
rcen
tage
dist
ribut
ion
of p
an
test
ban
d in
tens
itye
(n=7
0)Pe
rcen
tage
dist
ribut
ion
of P
v
test
ban
d in
tens
itye
(n=1
40)
Perc
enta
ge d
istrib
utio
n of
Pv
te
st b
and
inte
nsity
e (n
=70)
0a1
23
40a
12
34
0a1
23
40a
12
34
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
t IT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Avan
tage
P.f
Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Care
Star
t™M
alar
ia H
RP2
(Pf)
G01
41Ac
cess
Bio
. Inc
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
diag
nost
icks
- M
alar
ia (P
f)Cas
sett
e W
BKM
FC60
01SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
sN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Ca
rd T
est
I13F
RCPr
emie
r Med
ical
Cor
pora
tion
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
IMM
UN
OQU
ICK®
MAL
ARIA
falc
ipar
um
0502
_K25
BIOS
YNEX
N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
3St
anda
rd D
iagn
ostic
s In
c.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics (
Indi
a) P
VT. L
TD.
26.4
65.7
7.9
0.0
0.0
1.4
1.4
57.1
37.1
2.9
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
10.7
79.3
10.0
0.0
0.0
0.0
2.9
51.4
32.9
12.9
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
0.7
77.9
20.0
1.4
0.0
1.4
0.0
11.4
67.1
20.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
8.6
80.0
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NA
NA
NA
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NA
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NA
NA
NA
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NA
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NA
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7.9
62.9
27.9
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NA
NA
NA
NA
NA
NA
NA
NA
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Gen
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Gen
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A
Hum
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o., L
td.
3.6
64.3
30.0
2.1
0.0
1.4
0.0
17.1
55.7
25.7
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ICT
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AN
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Artr
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Inc.
82.9
17.1
0.0
0.0
0.0
1.4
52.9
40.0
5.7
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf/
Pan
One
Step
Rap
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RT 2
0222
Zhej
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nt G
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ech
Co., L
td.
2.1
57.9
38.6
1.4
0.0
1.4
0.0
11.4
68.6
18.6
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
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pf (
pLDH
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180
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70.
00.
00.
027
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AN
AN
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54.3
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NA
NA
NA
NA
NA
NA
NA
NA
NA
OnSi
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AN
AN
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AN
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A
Para
scre
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5031
0025
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27.9
62.1
10.0
0.0
0.0
0.0
2.9
50.0
35.7
11.4
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Righ
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td.
30.7
69.3
0.0
0.0
0.0
2.9
10.0
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0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
an
ne
Xes
101100 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
200
para
sites
/μL
2000
b pa
rasit
es/μ
L20
0 pa
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L20
00b
para
sites
/μL
Perc
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istrib
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pan
te
st b
and
inte
nsity
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=140
)Pe
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tage
dist
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test
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tens
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40)
Perc
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0a1
23
40a
12
34
0a1
23
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12
34
SD B
IOLI
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Mal
aria
Ant
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Pan
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60/0
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s In
c.
2.1
25.7
59.3
12.9
0.0
0.0
0.0
8.6
24.3
67.1
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Viki
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alar
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g Pf
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4124
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77.9
19.3
2.9
0.0
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4.3
30.0
58.6
7.1
0.0
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Pf a
nd P
v/Pv
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AN E
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Test
® M
alar
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f/Pa
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AM46
50-K
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Pha
rmac
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NA
NA
NA
NA
NA
NA
NA
NA
NA
27.1
64.3
8.6
0.0
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40.0
55.7
2.9
Mal
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evic
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nom
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olec
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gnos
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vt. L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
7.9
82.1
10.0
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2.9
1.4
50.0
41.4
4.3
Mal
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can®
Mal
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Pm, P
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tigen
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AT-P
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at B
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ech
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AN
AN
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A15
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.48.
60.
00.
01.
40.
045
.741
.411
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One
Step
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Tes
t (Ca
sset
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5233
52Bl
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ross
Bio
-Med
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Beiji
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o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
0.0
27.9
70.7
1.4
0.0
0.0
0.0
2.9
55.7
41.4
Para
HIT
®fV
Rapi
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alci
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m a
nd P
. viv
ax
Mal
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evic
e55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
31.4
57.9
10.7
0.0
0.0
7.1
1.4
35.7
51.4
4.3
Won
dfo®
One
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p M
alar
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v W
hole
Blo
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ngzh
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ondf
o Bi
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h Co
. Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
A35
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30.
00.
01.
42.
955
.732
.97.
1
Pan
only
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ntag
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n M
alar
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ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
0.0
15.0
72.9
10.7
1.4
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0.0
2.9
32.9
64.3
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Care
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1.4
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2.9
95.7
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA,
not
app
licab
lePf
, Pla
smod
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falc
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Pv,
Plas
mod
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viv
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pan
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spec
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Pvo
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%) o
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and
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μL
c Pa
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st li
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P. v
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line
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lcul
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ns in
clud
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valid
test
s
Tabl
e A
4.3
(con
tinue
d)
103102 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
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4.4:
Pan
el d
etec
tion
scor
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pha
se-2
wild
-typ
e P.
fal
cipa
rum
at
low
(200
) an
d hi
gh (2
000)
par
asit
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nsit
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/μL)
by
cont
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t
Prod
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Cata
logu
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num
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Man
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r
200
para
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2000
b pa
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LPa
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scor
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y co
ntin
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sam
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orig
inPa
nel d
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scor
ea b
y co
ntin
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of
sam
ple
orig
in
Afric
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(n=5
8)As
ia
(n=2
3)So
uth
Amer
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(n=1
9)Af
rica
(n
=58)
Asia
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Sout
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a (n
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Pf o
nly
Adva
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0160
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Mitr
a &
Co.
Pvt
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IMM
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KHB®
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apid
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73.9
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103102 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
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Ltd.
79.3
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94.7
96.6
95.7
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0
Mal
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can®
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PAN
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apid
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n M
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alar
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ple
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onsi
dere
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nly
if al
l RDT
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oth
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first
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P. f
alci
paru
m d
ilutio
n sa
mpl
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ets
had
200
and
5000
par
asite
s/μL
Tabl
e A
4.4
(con
tinue
d)
105104 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.5:
Pha
se-2
P. f
alci
paru
m t
est
line
fals
e-po
siti
ve r
ates
for
wild
-typ
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viv
ax s
ampl
es a
t lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
L)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=3
5)
200
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sites
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2000
a pa
rasit
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posi
tive
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fect
ionb
(%
)Fa
lse-
posi
tive
Pf in
fect
ionb
(%
)
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1 (n
=70)
Lot
2 (n
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Ove
rall
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40)
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tep
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est
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tage
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dIR
0160
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Mitr
a &
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Pvt
. Ltd
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0
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f VB
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nced
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ard
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ene
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tech
(Pty
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50.0
27.1
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34.3
40.0
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NG
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915
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apid
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sett
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o. L
td.
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IOLI
NE
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aria
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Xes
105104 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=3
5)
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sites
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rasit
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posi
tive
Pf in
fect
ionb
(%
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posi
tive
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fect
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(%
)
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1 (n
=70)
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2 (n
=70)
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rall
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=35)
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2 (n
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Ove
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ASAN
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st®
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Pan
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4650
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AN P
harm
aceu
tical
Co.
, Ltd
0.
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00.
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00.
0
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aria
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HRP
II)/ P
V (P
LDH
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igen
Det
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st D
evic
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M00
6G
enom
ix M
olec
ular
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gnos
tics
Pvt.
Ltd.
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(138
)0.
05.
72.
9
Mal
eris
can®
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aria
Pf/
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AT-P
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ech
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aria
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/P.V
Tes
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sset
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ross
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-Med
ical
(Bei
jing)
Co.
, Ltd
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.753
.642
.925
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Para
HIT®
fV R
apid
test
for P
. fal
cipar
um a
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viv
ax M
alar
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Devi
ce55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
10.0
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5.7
5.7
0.0
2.9
Won
dfo®
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Ste
p M
alar
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v W
hole
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72.
9
Pan
only
Adva
ntag
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n M
alar
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ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
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pan
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Pvo
m, P
lasm
odiu
m v
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nd m
alar
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(6%
) of t
he 3
5 P.
viv
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ilutio
n sa
mpl
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ts h
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00 a
nd 5
000
para
site
s/μL
b Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
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falc
ipar
um in
fect
ion
Tabl
e A
4.5
(con
tinue
d)
107106 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.6:
Pha
se-2
pan
(or
P. v
ivax
/\Pv
om)
test
line
fal
se-p
ositi
ve r
ate
for
non-
P. fa
lcip
arum
infe
ctio
n on
pha
se-2
wild
-typ
e P.
falc
ipar
um s
ampl
es a
t lo
w (2
00)
an
d hi
gh (2
000)
par
asit
e de
nsit
y (p
aras
ites
/µL)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=100
)
200
para
sites
/μL
2000
a pa
rasit
es/μ
LFa
lse-p
ositi
ve n
on-P
f in
fect
ion
(%)
False
-pos
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non
-Pf
infe
ctio
n (%
)
Lot
1 (n
=200
)Lo
t 2
(n=2
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107106 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
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Cata
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num
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Man
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14.5
16.5
91.0
80.0
85.5
Mal
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igen
Det
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3.1
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3.6
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Mal
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can®
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87.4
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5233
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09.
0
Para
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Devi
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Tabl
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4.6
(con
tinue
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109108 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
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4.7:
Pha
se-2
fal
se-p
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for
P. f
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paru
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line
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ll m
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Prod
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Cata
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num
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Man
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Perc
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f fa
lse-p
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f fa
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109108 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
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Cata
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num
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Man
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Perc
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4.7
(con
tinue
d)
111110 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.8:
Pha
se-2
fal
se-p
ositi
ve r
ate
for
P. f
alci
paru
m in
sam
ples
con
tain
ing
spec
ific
non-
mal
aria
l inf
ectio
us p
atho
gens
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse-p
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ves
for
Plas
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ctio
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atho
gen
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ueLe
ishm
ania
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agas
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Lot
2 (n
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Lot
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Lot
2 (n
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Lot
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Qua
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dIR
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0
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an
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Xes
111110 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e
num
ber
Man
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ture
r
Perc
enta
ge o
f fa
lse-p
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harm
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p.
Pvo
m, P
lasm
odiu
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le a
nd m
alar
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Tabl
e A
4.8
(con
tinue
d)
113112 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.9:
Pha
se-2
fal
se-p
ositi
ves
rate
for
P. f
alci
paru
m in
sam
ples
con
tain
ing
pote
ntia
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113112 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
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Cata
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num
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Man
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Perc
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115114 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
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4.10
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115114 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
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c
See
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r det
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Tabl
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4.10
(con
tinue
d)
117116 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.11
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pana
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n a
P. f
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ampl
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low
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nsit
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00 p
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/μL)
. Po
siti
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rat
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60 d
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afte
r in
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5 °C
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45
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Prod
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Cata
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45 °C
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Lot
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Lot
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Lot
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Lot
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Lot
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No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
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No. invalid
Mean band intensity
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No. invalid
Mean band intensity
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No. invalid
Mean band intensity
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No. invalid
Mean band intensity
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0
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0160
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Mitr
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115
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315
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Pan
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H)
NG
-MAL
-W23
-001
SARL
NG
Bio
tech
, Z.A
.15
.00.
02.
015
.00.
02.
015
.00.
02.
015
.00.
02.
115
.00.
02.
015
.00.
02.
0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h In
c.15
.00.
02.
015
.00.
01.
915
.00.
01.
715
.00.
01.
815
.00.
02.
015
.00.
01.
6
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
15.0
0.0
2.1
15.0
0.0
2.9
15.0
0.0
3.0
15.0
0.0
2.9
15.0
0.0
2.0
15.0
0.0
2.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
15.0
0.0
1.2
15.0
0.0
1.1
15.0
0.0
1.0
15.0
0.0
2.0
15.0
0.0
1.9
15.0
0.0
1.9
an
ne
Xes
117116 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
15.0
0.0
1.9
15.0
0.0
2.2
15.0
0.0
2.1
15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
2.3
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
15.0
0.0
1.1
15.0
0.0
1.8
15.0
0.0
1.0
14.0
1.0
1.0
15.0
0.0
1.0
14.0
0.0
1.0
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
15.0
0.0
1.1
15.0
0.0
1.0
14.0
0.0
1.0
15.0
0.0
1.1
8.0
0.0
1.0
11.0
0.0
1.0
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
10.0
1.0
2.0
15.0
0.0
2.0
12.0
1.0
2.0
15.0
0.0
1.9
12.0
1.0
1.8
13.0
1.0
1.8
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.15
.00.
02.
015
.00.
01.
915
.00.
01.
715
.00.
01.
915
.00.
02.
015
.00.
02.
0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.15
.00.
02.
215
.00.
02.
315
.00.
02.
115
.00.
02.
215
.00.
02.
915
.00.
02.
0
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um an
d P.
vivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.15
.00.
01.
915
.00.
01.
014
.00.
01.
115
.00.
01.
114
.00.
01.
015
.00.
01.
9
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.15
.00.
01.
915
.00.
01.
915
.00.
01.
914
.00.
02.
015
.00.
02.
013
.00.
01.
5
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
5.0
0.0
1.0
6.0
0.0
1.0
11.0
0.0
1.0
9.0
0.0
1.0
8.0
0.0
1.0
10.0
0.0
1.0
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
ND,
not
det
erm
ined
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
s P
vom
, Pla
smod
ium
viv
ax, o
vale
and
mal
aria
ea
For p
an-o
nly
test
s
Tabl
e A
4.11
(con
tinue
d)
119118 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.11
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
a P.
fal
cipa
rum
sam
ple
at lo
w p
aras
ite
dens
ity
(20
para
site
s/μL
).
Posi
tivi
ty r
ate
afte
r 60
day
s at
bas
elin
e (r
oom
tem
pera
ture
) an
d af
ter
incu
batio
n at
35
°C a
nd 4
5 °C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
Lot
1 (n
=15)
Lot
2 (n
=15)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics
(Indi
a) P
VT. L
TD.
1.0
0.0
1.0
0.0
0.0
ND
3.0
0.0
1.0
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
0.0
1.0
ND
0.0
3.0
ND
0.0
1.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
10.0
0.0
1.0
14.0
0.0
1.0
15.0
0.0
1.0
13.0
0.0
1.0
0.0
0.0
ND
8.0
0.0
1.0
BIOC
REDI
T M
alar
ia A
g Pf
/Pan
(HRP
II/pL
DH)
C30R
HA2
5Ra
piG
EN IN
C.0.
00.
0N
D0.
00.
0N
D1.
00.
01.
015
.00.
01.
00.
00.
0N
D0.
00.
0N
DBi
oTra
cer™
Mal
aria
Pf/
PAN
Rap
id C
ard
1701
2Bi
o Fo
cus
Co.,
Ltd.
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
8.0
0.0
1.0
12.0
0.0
1.0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) Com
boG
0131
Acce
ss B
io. I
nc.
13.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
11.0
0.0
1.0
9.0
0.0
1.0
7.0
0.0
1.0
Clea
rvie
w®
Mal
aria
Dua
lVB
20Or
geni
cs L
td.(I
S)0.
00.
0N
D0.
00.
0N
D2.
00.
01.
01.
00.
01.
01.
00.
01.
00.
00.
0N
DDI
AQU
ICK
Mal
aria
P.f/
Pan
Cass
ette
Z112
00CE
DIAL
AB G
mbH
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
1.0
ND
0.0
0.0
ND
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
Kit
RK M
AL 0
01Ad
vy C
hem
ical
Pvt
. Ltd
. (Af
filia
te o
f Bha
rat
Seru
ms
& V
acci
nes
Ltd.
)0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D1.
00.
01.
00.
00.
0N
D
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stI1
6FRC
Prem
ier M
edic
al C
orpo
ratio
n0.
00.
0N
D0.
00.
0N
D3.
00.
01.
00.
00.
0N
D0.
00.
0N
D0.
00.
0N
DG
enBo
dy™
Mal
aria
Pf/
Pan
AgM
ALAG
100
Gen
Body
Inc.
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01G
reen
Cro
ss M
edic
al S
cien
ce C
orp.
(Kor
ea)
1.0
0.0
2.0
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
4.0
0.0
1.3
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
DM
alar
ia P
f./Pa
n An
tigen
(MAL
Pf/
Pan)
Tes
t Kit
A03-
18-3
22Ar
tron
Lab
orat
orie
s In
c.0.
00.
0N
D3.
00.
01.
01.
00.
01.
00.
00.
0N
D0.
00.
0N
D0.
00.
0N
DM
alar
ia P
f/Pa
n On
e St
ep R
apid
Tes
tRT
202
22Zh
ejia
ng O
rient
Gen
e Bi
otec
h Co
., Lt
d.0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
D0.
00.
0N
DM
alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
eM
FV-1
24AZ
OG, I
NC.
3.0
0.0
1.0
1.0
0.0
1.0
14.0
0.0
1.0
14.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
-MAL
-W23
-001
SARL
NG
Bio
tech
, Z.A
.0.
00.
0N
D0.
00.
0N
D2.
00.
01.
00.
00.
0N
D0.
00.
0N
D0.
00.
0N
DOn
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech
Inc.
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
1.0
0.0
1.0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
2.0
0.0
1.0
1.0
0.0
1.0
1.0
0.0
1.0
0.0
0.0
ND
4.0
0.0
1.0
0.0
0.0
ND
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
0.0
0.0
ND
0.0
0.0
ND
3.0
0.0
1.0
3.0
0.0
1.0
15.0
0.0
1.0
15.0
0.0
1.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
1.0
ND
0.0
0.0
ND
0.0
0.0
ND
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um an
d P.
vivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AW
ondf
o® O
ne S
tep
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
tW
056-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ND,
not
det
erm
ined
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
an
ne
Xes
119118 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.12
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pana
) te
st li
ne o
n a
P. f
alci
paru
m s
ampl
e at
hig
h pa
rasi
te d
ensi
ty (2
000
para
site
s/μL
).
Posi
tivi
ty r
ate
afte
r 60
day
s at
bas
elin
e (r
oom
tem
pera
ture
) an
d af
ter
incu
batio
n at
35
°C a
nd 4
5 °C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
t IT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.5.
00.
02.
25.
00.
03.
05.
00.
02.
63.
02.
02.
05.
00.
02.
23.
02.
02.
0
Adva
ntag
e P.
f Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
03.
85.
00.
04.
05.
00.
04.
0
Care
Star
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alar
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RP2
(Pf)
G01
41Ac
cess
Bio
. Inc
.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
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04.
05.
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04.
0
diag
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alar
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A Di
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04.
05.
00.
04.
05.
00.
04.
05.
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04.
05.
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04.
05.
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04.
0
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
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um (H
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Car
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Prem
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n5.
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04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
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04.
0
IMM
UN
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MAL
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falc
ipar
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0502
_K25
BIOS
YNEX
5.
00.
03.
05.
00.
03.
05.
00.
03.
25.
00.
02.
25.
00.
03.
05.
00.
03.
0
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
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Bio
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inee
ring
Co.,L
td.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
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anda
rd D
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s In
c.
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
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en T
est
MAG
C 25
LAB-
CARE
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a) P
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5.0
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2.6
5.0
0.0
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5.0
0.0
3.0
5.0
0.0
2.6
5.0
0.0
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Adva
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Qua
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ia T
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Pf/P
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c Pr
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5.0
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3.0
5.0
0.0
3.0
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0.0
3.6
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0.0
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0.0
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5.0
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Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
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Adva
ntag
e M
alar
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an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
5.0
0.0
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
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T M
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g Pf
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04.
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04.
05.
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04.
05.
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04.
05.
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04.
05.
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03.
4
BioT
race
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alar
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f/PA
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apid
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Bio
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s Co
., Lt
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04.
05.
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04.
05.
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03.
85.
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03.
85.
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04.
05.
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03.
8
Care
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pLDH
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Clea
rvie
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Mal
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Dua
lVB
20Or
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td.(I
S)5.
00.
04.
05.
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04.
05.
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04.
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04.
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DIAQ
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K M
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0
EzDx
™ M
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tion
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AL 0
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Pvt
. Ltd
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filia
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rat
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)5.
00.
04.
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04.
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04.
05.
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04.
05.
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2
Firs
t Res
pons
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Prem
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04.
05.
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Gen
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ss M
edic
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cien
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orp.
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.4
5.0
0.0
3.0
5.0
0.0
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Hum
asis
Mal
aria
P.f/
Pan
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en T
est
AMAL
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o., L
td.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.0
5.0
0.0
3.0
ICT
Mal
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Dua
l Tes
tM
L03
ICT
INTE
RNAT
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AL5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n) T
est K
itA0
3-18
-322
Artr
on L
abor
ator
ies
Inc.
5.0
0.0
1.6
5.0
0.0
1.8
5.0
0.0
1.8
5.0
0.0
2.0
5.0
0.0
1.2
5.0
0.0
1.0
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
4.0
1.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, IN
C.5.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
0
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.0
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
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-W23
-001
SARL
NG
Bio
tech
, Z.A
.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
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3CCT
K Bi
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00.
03.
45.
00.
04.
05.
00.
03.
85.
00.
03.
85.
00.
04.
05.
00.
04.
0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
4.0
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
3.0
(con
tinue
d)
121120 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
5.0
0.0
2.8
5.0
0.0
3.8
5.0
0.0
3.0
5.0
0.0
2.2
5.0
0.0
2.6
5.0
0.0
2.6
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
5.0
0.0
3.0
5.0
0.0
3.0
5.0
0.0
2.8
5.0
0.0
3.0
5.0
0.0
2.2
5.0
0.0
2.0
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
5.0
0.0
4.0
5.0
0.0
4.0
4.0
1.0
3.3
5.0
0.0
3.6
3.0
1.0
3.0
4.0
1.0
3.0
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.5.
00.
03.
25.
00.
03.
45.
00.
04.
05.
00.
03.
05.
00.
03.
05.
00.
03.
0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.5.
00.
04.
05.
00.
04.
05.
00.
03.
65.
00.
04.
05.
00.
04.
05.
00.
04.
0
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um an
d P.
vivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.5.
00.
03.
25.
00.
03.
85.
00.
03.
65.
00.
04.
04.
00.
04.
05.
00.
04.
0
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.5.
00.
03.
85.
00.
04.
05.
00.
04.
05.
00.
03.
45.
00.
04.
05.
00.
04.
0
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
5.0
0.0
1.8
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
4.0
0.0
2.3
5.0
0.0
1.8
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
5.0
0.0
2.4
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
ND,
not
det
erm
ined
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
s P
vom
, Pla
smod
ium
viv
ax, o
vale
and
mal
aria
ea
For p
an-o
nly
test
s
Tabl
e A
4.12
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pana
) te
st li
ne o
n a
P. f
alci
paru
m s
ampl
e at
hig
h pa
rasi
te d
ensi
ty (2
000
para
site
s/μL
).
Posi
tivi
ty r
ate
afte
r 60
day
s at
bas
elin
e (r
oom
tem
pera
ture
) an
d af
ter
incu
batio
n at
35
°C a
nd 4
5 °C
(con
tinue
d)
an
ne
Xes
121120 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.12
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
a P.
fal
cipa
rum
sam
ple
at h
igh
para
site
den
sity
(200
0 pa
rasi
tes/
μL).
Po
siti
vity
rat
e af
ter
60 d
ays
at b
asel
ine
(roo
m t
empe
ratu
re)
and
afte
r in
cuba
tion
at 3
5 °C
and
45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
Lot
1 (n
=5)
Lot
2 (n
=5)
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
No. positive
No. invalid
Mean band intensity
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics
(Indi
a) P
VT. L
TD.
2.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
4.0
0.0
1.0
0.0
0.0
ND
3.0
0.0
1.0
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
4.0
0.0
1.0
3.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
3.0
0.0
1.0
5.0
0.0
1.0
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
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5.0
0.0
1.6
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BIOC
REDI
T M
alar
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g Pf
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05.
00.
02.
05.
00.
01.
05.
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01.
65.
00.
01.
05.
00.
01.
0Bi
oTra
cer™
Mal
aria
Pf/
PAN
Rap
id C
ard
1701
2Bi
o Fo
cus
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Ltd.
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
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0.0
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0.0
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Care
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t™ M
alar
ia H
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5.0
0.0
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5.0
0.0
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0.0
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Clea
rvie
w®
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lVB
20Or
geni
cs L
td.(I
S)4.
00.
01.
05.
00.
01.
05.
00.
01.
04.
00.
01.
05.
00.
01.
05.
00.
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AQU
ICK
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aria
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Pan
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ette
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mbH
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0.0
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0.0
1.0
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0.0
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5.0
0.0
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0.0
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EzDx
™ M
alar
ia P
an/P
f Rap
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est D
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tion
Kit
RK M
AL 0
01Ad
vy C
hem
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filia
te o
f Bha
rat
Seru
ms
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acci
nes
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)5.
00.
01.
05.
00.
01.
45.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
0
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
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mbo
Car
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stI1
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edic
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orpo
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n5.
00.
01.
05.
00.
01.
25.
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01.
25.
00.
01.
05.
00.
01.
05.
00.
01.
0G
enBo
dy™
Mal
aria
Pf/
Pan
AgM
ALAG
100
Gen
Body
Inc.
1.0
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0.0
1.0
5.0
0.0
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0.0
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Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01G
reen
Cro
ss M
edic
al S
cien
ce C
orp.
(Kor
ea)
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
0.0
0.0
ND
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
5.0
0.0
1.0
5.0
0.0
1.2
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL4.
00.
01.
05.
00.
01.
05.
00.
01.
04.
00.
01.
05.
00.
01.
04.
00.
01.
0M
alar
ia P
f./Pa
n An
tigen
(MAL
Pf/
Pan)
Tes
t Kit
A03-
18-3
22Ar
tron
Lab
orat
orie
s In
c.5.
00.
01.
05.
00.
01.
65.
00.
01.
05.
00.
01.
45.
00.
01.
04.
00.
01.
0M
alar
ia P
f/Pa
n On
e St
ep R
apid
Tes
tRT
202
22Zh
ejia
ng O
rient
Gen
e Bi
otec
h Co
., Lt
d.5.
00.
01.
05.
00.
01.
05.
00.
01.
04.
01.
01.
05.
00.
01.
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00.
01.
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alar
ia p
f (pL
DH) /
PAN
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H T
est D
evic
eM
FV-1
24AZ
OG, I
NC.
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0.0
1.0
2.0
0.0
1.5
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
5.0
0.0
1.0
5.0
0.0
2.0
5.0
0.0
2.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
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-001
SARL
NG
Bio
tech
, Z.A
.5.
00.
01.
25.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
05.
00.
01.
0On
Site
Pf/
Pan
Ag R
apid
Tes
tR0
113C
CTK
Biot
ech
Inc.
4.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
5.0
0.0
1.2
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
5.0
0.0
1.0
5.0
0.0
1.0
3.0
0.0
1.0
3.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
5.0
0.0
1.0
5.0
0.0
1.6
5.0
0.0
1.8
5.0
0.0
1.8
5.0
0.0
1.0
5.0
0.0
2.0
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
3.0
0.0
1.0
3.0
0.0
1.0
5.0
0.0
1.0
1.0
0.0
1.0
0.0
0.0
ND
0.0
0.0
ND
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AOn
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)52
3352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um an
d P.
vivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AW
ondf
o® O
ne S
tep
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
tW
056-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
ND,
not
det
erm
ined
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
123122 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.13
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan)
tes
t lin
e on
par
asit
e-ne
gati
ve s
ampl
es.
Posi
tivi
ty r
ate
afte
r 60
day
s at
bas
elin
e (r
oom
tem
pera
ture
) an
d af
ter
incu
batio
n at
35
°C a
nd 4
5 °C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
t IT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.0.
00.
00.
00.
00.
00.
01.
00.
00.
00.
00.
00.
0
Adva
ntag
e P.
f Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Care
Star
t™M
alar
ia H
RP2
(Pf)
G01
41Ac
cess
Bio
. Inc
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
diag
nost
icks
- M
alar
ia (P
f)Cas
sett
e W
BKM
FC60
01SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Car
d Te
stI1
3FRC
Prem
ier M
edic
al C
orpo
ratio
n0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
IMM
UN
OQU
ICK®
MAL
ARIA
falc
ipar
um
0502
_K25
BIOS
YNEX
0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf
05FK
50/0
5FK5
3St
anda
rd D
iagn
ostic
s In
c.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Visi
on M
alar
ia P
f VB
01Vi
sion
Bio
tech
(Pty
) Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics
(Indi
a) P
VT. L
TD.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
1.0
0.0
1.0
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
BIOC
REDI
T M
alar
ia A
g Pf
/Pan
(HRP
II/pL
DH)
C30R
HA2
5Ra
piG
EN IN
C.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
BioT
race
r™ M
alar
ia P
f/PA
N R
apid
Car
d17
012
Bio
Focu
s Co
., Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) Com
boG
0131
Acce
ss B
io. I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Clea
rvie
w®
Mal
aria
Dua
lVB
20Or
geni
cs L
td.(I
S)0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
DIAQ
UIC
K M
alar
ia P
.f/Pa
n Ca
sset
teZ1
1200
CEDI
ALAB
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bH0.
00.
00.
00.
00.
00.
01.
00.
00.
00.
00.
00.
0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
Kit
RK M
AL 0
01Ad
vy C
hem
ical
Pvt
. Ltd
. (Af
filia
te o
f Bha
rat S
erum
s &
Vac
cine
s Lt
d. )
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
2.0
0.0
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stI1
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edic
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orpo
ratio
n0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Gen
Body
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alar
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f/Pa
n Ag
MAL
AG10
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enBo
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c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Gen
edia
® M
alar
ia P
.f/Pa
n Ag
Rap
id T
est
20-0
146-
01G
reen
Cro
ss M
edic
al S
cien
ce C
orp.
(Kor
ea)
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL0.
00.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n) T
est K
itA0
3-18
-322
Artr
on L
abor
ator
ies
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, IN
C.1.
00.
00.
00.
00.
00.
02.
00.
00.
00.
02.
00.
0
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
2.0
0.0
4.0
0.0
2.0
0.0
4.0
0.0
4.0
0.0
2.0
0.0
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
-MAL
-W23
-001
SARL
NG
Bio
tech
, Z.A
.1.
00.
01.
00.
00.
00.
04.
00.
00.
00.
04.
00.
0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
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K Bi
otec
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c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
an
ne
Xes
123122 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.4.
00.
04.
00.
04.
00.
04.
00.
04.
00.
04.
00.
0
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um a
nd P.
viv
ax M
alar
ia -
Devi
ce55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Care
Star
t™M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io. I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
s P
vom
, Pla
smod
ium
viv
ax, o
vale
and
mal
aria
ea
For p
an-o
nly
test
s
Tabl
e A
4.13
(con
tinue
d)
125124 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Tabl
e A
4.13
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
para
site
-neg
ativ
e sa
mpl
es.
Posi
tivi
ty r
ate
afte
r 60
day
s at
bas
elin
e (r
oom
tem
pera
ture
) an
d af
ter
incu
batio
n at
35
°C a
nd 4
5 °C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35 °C
45 °C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf a
nd p
anAC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
Antig
en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics
(Indi
a) P
VT. L
TD.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
1005
InTe
c Pr
oduc
ts, I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
1.0
0.0
1.0
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Adva
ntag
e M
alar
ia P
an +
Pf C
ard
IR23
1025
J. M
itra
& C
o. P
vt. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
BIOC
REDI
T M
alar
ia A
g Pf
/Pan
(HRP
II/pL
DH)
C30R
HA2
5Ra
piG
EN IN
C.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
BioT
race
r™ M
alar
ia P
f/PA
N R
apid
Car
d17
012
Bio
Focu
s Co
., Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
0
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) Com
boG
0131
Acce
ss B
io. I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Clea
rvie
w®
Mal
aria
Dua
lVB
20Or
geni
cs L
td.(I
S)1.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
DIAQ
UIC
K M
alar
ia P
.f/Pa
n Ca
sset
teZ1
1200
CEDI
ALAB
Gm
bH0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
EzDx
™ M
alar
ia P
an/P
f Rap
id T
est D
etec
tion
Kit
RK M
AL 0
01Ad
vy C
hem
ical
Pvt
. Ltd
. (Af
filia
te o
f Bha
rat S
erum
s &
Vac
cine
s Lt
d. )
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
2.0
0.0
Firs
t Res
pons
e® M
alar
ia A
g. p
LDH
/HRP
2 Co
mbo
Car
d Te
stI1
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ier M
edic
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orpo
ratio
n0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Gen
Body
™M
alar
ia P
f/Pa
n Ag
MAL
AG10
0G
enBo
dy In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Gen
edia
® M
alar
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.f/Pa
n Ag
Rap
id T
est
20-0
146-
01G
reen
Cro
ss M
edic
al S
cien
ce C
orp.
(Kor
ea)
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
Hum
asis
Mal
aria
P.f/
Pan
Antig
en T
est
AMAL
-702
5H
umas
is C
o., L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
ICT
Mal
aria
Dua
l Tes
tM
L03
ICT
INTE
RNAT
ION
AL0.
00.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
aria
Pf./
Pan
Antig
en (M
AL P
f/Pa
n) T
est K
itA0
3-18
-322
Artr
on L
abor
ator
ies
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
Pf/
Pan
One
Step
Rap
id T
est
RT 2
0222
Zhej
iang
Orie
nt G
ene
Biot
ech
Co.,
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, IN
C.3.
00.
00.
00.
04.
00.
04.
00.
04.
00.
04.
00.
0
MD
Mal
aria
Pf/
Pan(
pLDH
) tes
tM
DMAL
LDH
001
Med
ical
Dia
gnos
tech
(Pty
) Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
NG
-Tes
t MAL
ARIA
Pf/
Pan
(pLD
H)
NG
-MAL
-W23
-001
SARL
NG
Bio
tech
, Z.A
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
OnSi
te P
f/Pa
n Ag
Rap
id T
est
R011
3CCT
K Bi
otec
h In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Para
scre
en®
Rapi
d te
st fo
r mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
als
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Righ
tSig
n™ M
alar
ia P
.f./P
an R
apid
Tes
t Cas
sett
eIM
PN-C
52H
angz
hou
Biot
est B
iote
ch C
o. L
td.
0.0
0.0
0.0
0.0
4.0
0.0
0.0
0.0
3.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ant
igen
Pf/
Pan
05FK
60/0
5FK6
3St
anda
rd D
iagn
ostic
s In
c.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf a
nd P
v/Pv
omAS
AN E
asy
Test
® M
alar
ia P
f/Pa
n Ag
AM46
50-K
ASAN
Pha
rmac
eutic
al C
o., L
td
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
aria
Pf (
HRP
II)/ P
V (P
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e G
M00
6G
enom
ix M
olec
ular
Dia
gnos
tics
Pvt.
Ltd.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
Para
HIT®
fV R
apid
test
for P
. fal
cipar
um a
nd P.
viv
ax M
alar
ia -
Devi
ce55
IC40
2-50
Span
Dia
gnos
tics
Ltd.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
an
ne
Xes
125124 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
annex 5: introducing rdt-based malaria diagnosis into national programmesIntroduction of parasite-based diagnosis at small clinics and at village level for case management poses many challenges, not only of logistics but also in managing the health-seeking and health-providing behaviour of patients and health workers. These can be addressed by a clear, time-bound strategic plan covering planning, implementation, monitoring and evaluation of the diagnosis programme, which must begin well before RDTs are procured. Furthermore, funding for the programme must include a significant component for planning and coordination, sensitization, information, education and communication, training, quality assurance, monitoring, supervision and logistics, in addition to procurement. In the absence of such funding, much of the expenditure on RDTs will be wasted, and loss of confidence in RDT-based
diagnosis can hinder strengthening of appropriate malaria case management. A focal person or persons should be available to coordinate the overall implementation plan and to ensure that the various agencies involved understand the process and their own roles.
Examples of successful wide-scale introduction of malaria RDTs by various national programmes and comprehensive technical guidance on achieving universal access to malaria diagnostic testing have been reported (1,2). Figures A5.1 and A5.2 give examples of the steps and timelines for RDT imple-mentation and budget components for a malaria diagnosis programme, respectively. These will have to be modified considerably for each programme.
Key challenges
Changing past thinking that “fever equals malaria unless proven otherwise”.
Introducing RDTs will disprove this statement. To have an impact on malaria diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis by both health workers and patients, that is, they must be as good or better than those relied on previously. A health worker requires a good alternative to antimalarial medicines for the management of parasite-negative febrile patients. To achieve and maintain confidence in RDT-based diagnosis, a good quality assurance system must be in place. There must be satisfactory education of health workers and widespread community sensitization. Health workers should have understanding of other causes of fever in order to devise appropriate management algorithms for parasite-negative cases.
Changing and enforcing regulatory requirements
At the national level, regulation might be required to control the importation and use of malaria RDTs, and new procedures for storage, distribution and inventory management, such as those used for medicines, might be necessary.
127126 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figu
re A
5.1.
Exa
mpl
e of
mal
aria
RDT
impl
emen
tatio
n st
eps
and
timel
inea
RDT
IMPL
EMEN
TATI
ON
TIM
ELIN
E
Coor
dina
ting
grou
pAp
poin
t m
alar
ia d
iagn
osis
coor
dina
tor(
s)
Polic
y re
com
men
datio
nsW
ritte
nM
oH e
ndor
sem
ent
Prog
ram
me
plan
ning
Guid
elin
esb
Writ
ten
MoH
end
orse
men
t
Case
man
agem
ent
of f
ever
of
unkn
own
orig
in
Case
man
agem
ent
of m
alar
ia
RDT
(and
mic
rosc
opy)
qua
lity
assu
ranc
e
RDT
tran
spor
t an
d st
orag
e
Deci
de d
istric
ts f
or in
itial
/ ph
ased
impl
emen
tatio
n
Feve
r m
anag
emen
t al
gorit
hmW
ritte
nM
oH e
ndor
sem
ent
Com
mun
ity s
ensit
izat
ion
Gene
ral h
ealth
car
e pr
ovid
ers’
educ
atio
n
Dete
rmin
e / d
esig
nate
tran
spor
t and
stor
age
met
hods
Regu
lato
ry is
sues
Defin
e co
llabo
rativ
e ro
les (
NM
P an
d re
gula
tory
bod
y)
Writ
e/ad
opt
regu
lato
ry g
uidl
eine
s
Crea
te R
DT r
egist
ry f
or r
efer
ence
Dsse
min
ate
regu
lato
ry c
riter
ia
Prod
uct
sele
ctio
n, s
uppl
y ch
ain
man
agem
ent
Sele
ct s
ever
al p
rodu
cts
Sam
ples
for
eas
e-of
-use
ass
essm
ent
Fina
l dec
ision
on
RDT
Neg
otia
te s
peci
ficat
ions
with
man
ufac
ture
r
Com
petit
ive
bidd
ing
and
proc
urem
ent
Depe
nden
t on
regis
tratio
n pr
oces
s
Rece
ive
first
bat
ch (o
f st
agge
red
deliv
ery)
Dist
ribut
ion
to f
ield
Proc
ure
glov
es
Proc
ure
shar
ps b
oxes
Proc
ure
othe
r as
soci
ated
mat
eria
ls
RDT
qual
ity c
ontr
olW
rite
sent
inel
site
SO
P
Set u
p/en
gage
fiel
d-ba
sed
qual
ity co
ntro
l mon
itorin
g sit
es
Deci
de o
n lo
t-te
stin
g sit
eDe
term
ine
site
Com
men
ce t
estin
g
Post
-mar
ketin
g su
rvei
llanc
ec
an
ne
Xes
127126 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Trai
ning
Cond
uct
case
man
agem
ent
trai
ning
for
fev
erM
ay b
e co
nduc
ted
earli
er, o
r al
read
y in
pla
ce
Mod
ify R
DT in
stru
ctio
ns a
nd t
rain
ing
man
ual
Fiel
d-te
st m
odifi
ed t
rain
ing/
inst
ruct
ions
Trai
ning
of
trai
ners
and
sup
ervi
sors
Hea
lth w
orke
r tr
aini
ng
Advo
cacy
, com
mun
icat
ion,
soc
ial m
obili
zatio
nEn
gagi
ng c
ivil
soci
ety
orga
niza
tions
Com
mun
ity s
ensit
izat
ion
Enga
ging
opi
nion
lead
ers
Gene
ral h
ealth
car
e ed
ucat
ion
Mon
itorin
g an
d ev
alua
tion
Deve
lop/
adop
t ap
prop
riate
rec
ord
form
s
Defin
e m
etho
ds f
or c
aptu
ring
diff
eren
t in
dica
tors
Inte
rgra
te R
DTs
into
the
rou
tine
heal
th in
form
atio
n m
anag
emen
t sy
stem
Plan
for
a p
ost-
intr
oduc
tion
prog
ram
me
revi
ew
MoH
, min
istr
y of
hea
lth; N
MP,
nat
iona
l mal
aria
pro
gram
me
a Ad
apte
d w
ith p
erm
issi
on fr
om F
IND
and
Uga
nda
Nat
iona
l Mal
aria
Con
trol
Pro
gram
me
b M
ay a
lread
y be
in p
lace
c Se
ntin
el s
ite m
ciro
scop
y, po
ssib
ly p
ositi
ve c
ontr
ol w
ells
in fu
ture
Figu
re A
6.1
(con
tinue
d)
129128 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Figure A5.2. Components of the budget for a malaria diagnosis programmea
Component Activities specific to microscopy
Activities specific to RDTs
Activities for management of malaria and non-malaria fevers
Preparation of technical guidelines, standard operating procedures and checklists
Guidelines Laboratory supervisionb RDT transport and storage Fever management algorithm
Standard operating procedures for diagnostic testing Microscopy performance RDT performance Other tests used at primary
care level
Other standard operating procedures Proficiency testing, validation of routine slide results RDT storage
Training material Training manual for microscopy Training manual for RDTs
Training manuals for integrated management of fevers
Checklists for supervision Laboratory visitsb Health facility visits
Procurement and supply of commodities
Diagnostic tests Microscopes and related supplies RDT kits
Urine dipsticks, haemoglobin meter, haematocrit meter, glucometer
Medicines Artemisinin-based combination therapy Antibiotics, zinc, inhaled salbutamol, rehydration salts
Other commodities Gloves, lancets, alcohol, cotton-wool, timers, sharps boxes
Distribution of commodities to the field All items listed above
Quality management system
Pre-shipment testing Lot-testing
Training of focal people Quality management system for focal people
Monitoring the quality management system
Quality monitoring supervision visits and compilation of health information management data
Training of health workers
Training of tutors Expert microscopists Tutors for RDT performance outside laboratories and clinical management of fever cases
Training of health workers Microscopists Health workers Clinicians
Training of supervisors Laboratory supervisorsb Clinical supervisors
Supervision
Supervisory visits Laboratory visitsb Health facility visits
Advocacy, communication and social mobilization
Design of strategies and material Communication on the need for malaria testing Communication on other causes of fever
Dissemination of key messages Through each delivery channel
Monitoring and evaluation
Updating the health information management system
Add row for RDTs in laboratory report and column for malaria test results in clinicians’ book
Column for other test results in clinicians’ book
Train health workers in the new health information management system
Training of person in charge or focal person for reporting on health information management in health facilities
a Adapted with permission (37)b For simplicity, activities specific to laboratories are listed under ‘Microscopy’, although both microscopy and RDT are generally performed in laboratories.
an
ne
Xes
129128 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
references1. Universal access to malaria diagnostic testing: an operational manual. Geneva: World Health Organization; 2011.
2. Thiam S, Thior M, Faye B, et al. Major reduction in anti-malarial drug consumption in Senegal after nation-wide intro-duction of malaria rapid diagnostic tests. PLoS One 2011; 6: e18419.
131130 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 5 (2013)
Notes
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131130
Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
HO p
rodu
ct te
sting
of m
alaria
RDT
s: Ro
und
5 (2
013)
Couv Rd5_VertTurq-st2.indd 1 17/07/14 15:37
Global Malaria Programme World Health Organization20, Avenue Appia1211 Geneva 27Switzerland
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