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PARACHECK PfM A L A R I A · R D T

A COMPENDIUM OF DECADE LONG PERFORMANCE DATA

ISO 9001: 2000, ISO 13485(2003), NF EN ISO 13485 (2004)

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AUGUST 2 0 0 9

The Clinically proven RDTPARACHECK Pf

Background

Early rapid diagnosis of malaria is crucial to the

health care programmes in endemic countries.

Their increasing importance is in response to

increasing drug costs and recognition of the

importance of early and correct treatment to attain

reduction in malaria morbidity and mortality.

Malaria RDTs in the last decade have played a

vital role in this regard in reaching objective

treatment to affected populations even in resource

poor settings, where the traditional microscopic

diagnosis is either impractical or impossible.

During the last decade or so, Paracheck Pf RDT

has emerged as the most regarded brand of

Malaria RDTs for the detection of P.falciparum

infections with the usage in approximately over 70

countries and about 100 million test sold

worldwide.

Paracheck Pf RDT is the most widely used global

benchmark and most peer reviewed, with a

plethora of publications that vouch for its clinical

performance in laboratory as well as field setting.

The sensitivity, specificity, reliability, thermal

stability, user friendliness and consistency of

Paracheck Pf has been widely evaluated, studied

and reported at field level and has been

established equally well in the hands of experts,

over the years.

This data has been compiled and presented for the

attention of users and decision makers so as to

review the performance characteristics of

Paracheck Pf, the malaria RDT that's clinically

proven, worldwide.

Index

Background 1

Paracheck Pf Specifications of Components 2

Architecture and Design of Paracheck Pf 3

Countries Around The World to Which Paracheck Pf is Exported 4

Paracheck Pf Production in Quantity of Tests Since the Year 1998 till Date 5

Summary of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centres in Cambodia and Philippines 6

Details of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centre in Cambodia 7 -12

Details of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centre in Philippines 13 - 15

W.H.O./RITM Malaria Rapid Diagnostic Test Quality Assurance Initiative Temperature Stability Monitoring of Paracheck Pf 16 - 22

Preliminary Summary Results of Malaria RDT Multi-Centre Heat Stability Study, 2004 for Paracheck Pf 23 - 26

Internal Stability Studies Conducted for 0 0

Paracheck Pf at 2-8 C, R.T. and 45 C 27 - 33

Summary of Paracheck Pf Evaluations 35 - 37

Bibliography 38

Rapid Diagnostic Tests (RDT) for the diagnosis of P. falciparum Malaria Comparison of validity, reliability and other characteristics of 5 tests in Uganda 34

1 The Clinically proven RDTPARACHECK Pf

The Clinically proven RDTPARACHECK Pf 2

The Essential Components of Paracheck Pf

W = Wicking area for sample / buffer.

H = HAMA Blocking Reagents embedded on sample pad.

A = Conjugate pad containing monoclonal Anti Pf. HRP-II (IgG) colloidal gold conjugate antibody.

T = Test line striped with monoclonal Anti Pf. HRP-II (IgM) antibody.

n = Microporous nitrocellulose membrane.

C = Control line striped with Anti Rabbit Antibodies to give a test run validation.

S = Soak pad that absorbs the unreacted sample post test conclusion.

P = Plastic housing.

Components To Be Used With Paracheck Pf RDTs:

Desiccant with indicator to ensure moisture free pack.

Buffer bottle for test run.

Sample dispensing loop.

Lancet for obtaining finger prick blood*.

Alcohol swab*.

Package insert / usage instructions.

* Supplied with the kit based on specific customer agreements.

Architecture and Design of Paracheck Pf

C

S C n T A WHP


Countries Around The World To Which Paracheck Pf Is Exported

1. Cameroon2. Egypt3. Ethiopia4. Ghana5. Kenya6. Mauritius7. Mozambique8. Nigeria9. South Africa10. Tanzania11. Zambia12. Gambia13. Bangladesh14. Cambodia15. Indonesia16. Laos17. Malaysia18. DRC Congo19. Mongolia20. Liberia21. Myanmar22. Nepal23. Philippines24. Lao PDR

25. Thailand26. Austria27. Denmark28. France29. Germany30. Belgium31. Netherlands32. Romania33. Switzerland34. Turkey35. UK36. Australia37. Botswana38. Pakistan39. Japan40. Senegal41. Malawi42. Eritrea43. Benin44. Guyana45. Central African Republic46. Guinea Bissau47. Sudan48. Chad

49. Liberia50. Yemen51. Surinamo52. Uganda53. Madagascar54. Angola55. Namibia56. China57. Canada58. Rwanda59. Togo60. Lome61. Burundi62. Italy63. Vietnam64. Republic of Congo65. Zimbabwe66. Singapore67. Ireland68. India69. Ivory Coast70. Comoros Island


Paracheck Pf Production in Quantity of Tests since the Year 1998 till Date


Paracheck Pf. (Device) Production

in number of tests

Paracheck Pf. (Dipstick) Production in number of tests

19

98

-19

99

19

99

-20

00

20

00

-20

01

20

01

-20

02

20

02

-20

03

20

03

-20

04

20

04

-20

05

20

05

-20

06

20

06

-20

07

20

07

-20

08

20

08

-20

09

0

50

00

00

0

10

00

00

00

15

00

00

00

20

00

00

00

25

00

00

00

45

29

53

78

37

52

00

43

5

85

19

40

51

68

45

69

66

45

119

21

20

23

95

67

5

55

40

25

0

72

16

31

0

86

34

70

12

53

00

61

63

60

14

21

26

5

22

81

28

5

50

20

81

5

75

54

87

5

13

05

16

95

22

86

55

60

16

64

92

95

23

26

38

45

Yea

rs

Number of tests

Mo

re t

han

105

mill

ion

tes

ts in

6 y

ears

Summary of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centres in Cambodia & Philippines


Lot No. Mfg. Expiry Testing Laboratory Report Dt. Result

21139 12/2004 11/2006 24/01/2005 Pass

31088 02/2008 01/2010 06/07/2009 Pass

31092 02/2008 01/2010 06/07/2009 Pass

31496

31497

31498 10/2008 09/2010 07/07/2009 Pass

31499

31500

31625

31626

31628

31629

31630 02/2009 01/2011 28/07/2009 Pass

31632

31633

31634

31635

31672 06/2009 05/2011 17/06/2009 Pass

31673 06/2009 05/2011 17/06/2009 Pass

31674 06/2009 05/2011 07/07/2009 Pass

O2134406/2009 05/2011 28/07/2009 Pass

O21346

31678

3168007/2009 06/2011 22/07/2009 Pass

31681

31682

31023A 10/2001 02/2003 03/03/2003 Pass

31049A 05/2003 10/2004 03/03/2003 Pass

31667 05/2009 04/2011 09/06/2009 Pass

31668

3166905/2009 04/2011 22/07/2009 Pass

31670

31675

3167606/2009 05/2011 20/07/2009 Pass

31677

Research Institute for Tropical Medicine, FCC Cpd., Alabang, Muntinlupa City 1781, Philippines.

Institute Pasteur of Cambodia, 5, Boulevard Monivong, BP 983-Phnom Penh, Cambodia.

“

“

“

“

“

“

“

“

“

“

“

“

“

Details of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centre in Cambodia

Aim: Various lots of Paracheck Pf malaria RDTs manufactured and supplied for public procurement were tested under the W.H.O.

malaria RDT QC initiative in co-operation with W.H.O.-FIND-TDR, to assess their sensitivity, specificity and performance at the

W.H.O. Lot Testing Centre, Institute Pasteur of Cambodia, 5, Boulevard Monivong, BP 983-Phnom Penh, Cambodia.

Protocol:

1. QC testing Method:

RDTs were tested with frozen QC samples based on the algorithm described in SOP 2.06 of the W.H.O. Quality Control

Methods Manual for Malaria RDTs. For a lot of RDTs to pass the QC assessment, all quality control dilutions must be

positive (100%). RDTs which do not meet these criteria will be forwarded to a second laboratory for confirmation. False

positive results will be reported in the 'Observations' section.

The RDT lots will be retained in this laboratory for long term Quality Control. A further report will be issued after the next

QC assessment.

2. Samples used for QC testing:

Quality control (QC) samples of dilutions from wild-parasites prepared according to SOP 3.08 of the W.H.O Quality 0

Assurance Methods Manual for Malaria RDTs. Samples are stored at -70 C.

Samples used include:

a) Negative control : 0 parasites/μl of Plasmodium spp.

b) Low Positive Control : 200 parasites/μl of Plasmodium falciparum.

c) High Positive Control : 2000 parasites/μl of Plasmodium falciparum.

d) Low Positive Control : 200 parasites/μl of Plasmodium vivax*.

e) Medium Positive Control : 500 parasites/μl of Plasmodium vivax*.

f) High Positive Control : 2000 parasites/μl of Plasmodium vivax*.

* delete as necessary

Interpretation of results:

For a lot of RDTs to pass the QC assessment, all positive quality control dilutions must be positive (100%). Performance on

Plasmodium negative control samples should also be taken into account when interpreting results.

● PASS: This RDT lot passed the quality control test and the RDT sample assessed detects antigen at a threshold

SUFFICIENT FOR USE in the field.

● DEFERRED: This RDT lot failed this assessment, and has been sent to another institution for confirmation. A final report

will be issued on receipt of the confirmatory results. It is recommended that the lot is RETAINED until a final report is

received.

● FAIL: This RDT lot failed the initial QC assessment and also failed confirmatory testing at another institution. It is

recommended that this lot should NOT BE USED in the field as it has been assessed as lacking sufficient sensitivity. It is

recommended that the manufacturer be contacted and advised of the results.

The reports are archived at the Orchid Biomedical Systems QA reference data base and can be obtained on request via e-mail.

The details of batch-wise Paracheck Pf RDT QC testing results at Cambodia are provided below:


Quality control dilutions Paracheck Pf Lot: 31625 Paracheck Pf Lot: 31626

RDTs RDTs RDTs RDTsSample ID (parasites/µl) % Positive % Positive

Tested Positive Tested Positive

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

RDTs RDTs % RDTs RDTs %Tested Negative Negative Tested Negative Negative

0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)

C3F2 (Pf)(Initial testing only)


Negative Control

C2F21

C2F3

Negative Control

Quality control dilutions Paracheck Pf Lot: 21139

RDTs RDTsSample ID (parasites/µl) % Positive

Tested Positive

200 2 2 100

2000 1 1 100

200 2 2 100

2000 1 1 100

RDTs RDTs %Tested Negative Negative

0 10 10 100




200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control





200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control




200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control




200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control


Quality control dilutions Paracheck Pf Lot: 31674 Paracheck Pf Lot: 31092*



200 2 2 100 6 6 100

2000 1 1 100 3 3 100

200 2 2 100 6 6 100

2000 1 1 100 3 3 100

200 2 2 100 6 6 100

2000 1 1 100 3 3 100

200 2 2 100 - - -

2000 1 1 100 - - -

Pf (C4F2)

Pf (C3F1)

Pf (C3F2) (Initial testing only)

Pf (C3F3)(Initial testing only)

*Lot 31092 has been tested in three different districts of Cambodia and the data displayed in the table has been combined for all the three lots.



Tested Positive

200 2 2 100

2000 1 1 100

200 2 2 100

2000 1 1 100

200 2 2 100

2000 1 1 100

200 - - -

2000 - - -

Pf (C4F2)

Pf (C3F1)






200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control





200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control




200 2 2 100 2 2 100

2000 1 1 100 1 3 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

Pf (C4F2)

Pf (C3F1)



Conclusion:

All the Paracheck Pf RDT lots tested at the WHO Lot Testing Centre in Cambodia passed the quality control tests for

their sensitivity and specificity and the RDT samples assessed detect antigens at the threshold, SUFFICIENT FOR USE

in the field.


Details of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centre in Philippines

Aim:

Various lots of Paracheck Pf malaria RDT's manufactured and supplied for public procurement were tested under the W.H.O.

malaria RDT QC initiative in co-operation with W.H.O.-FIND-TDR, to assess their sensitivity, specificity and performance at the

W.H.O. Lot Testing Centre, Research Institute for Tropical Medicine, FCC Cpd., Alabang, Muntinlupa City 1781, Philippines.

Protocol:

1. QC testing Method:

RDTs were tested with frozen QC samples based on the algorithm described in SOP 4.3 of the W.H.O. Quality Control

Methods Manual for Malaria RDTs. For a lot of RDTs to pass the QC assessment, all quality control dilutions must be

positive (100%). RDTs which do not meet these criteria will be forwarded to a second laboratory for confirmation. False

positive results will be reported in the 'Observations' section.

The RDT lots will be retained in this laboratory for long term Quality Control. A further report will be issued after the next

QC assessment.

2. Samples used for QC testing:

Quality control (QC) samples of dilutions from wild-parasites prepared according to SOP 5.2 of the WHO Quality 0

Assurance Methods Manual for Malaria RDTs. Samples are stored at -80 C.

Samples used include:

a) Negative control : 0 parasites/µl of Plasmodium falciparum.

b) Low Positive Control : 200 parasites/µl of Plasmodium falciparum (C2F21, 200, C2F3 200).

c) High Positive Control : 2000 parasites/µl of Plasmodium falciparum (C2F21 2000, C2F3 2000).

Interpretation of results:

For a lot of RDTs to pass the QC assessment, all positive quality control dilutions must be positive (100%). Performance on

Plasmodium negative control samples should also be taken into account when interpreting results.

● PASS: This RDT lot passed the quality control test and the RDT sample assessed is SUFFICIENTLY SENSITIVE FOR

USE in the field.

The reports are archived at the Orchid Biomedical Systems QA reference data base and can be obtained on request via e-mail.

The details of batch wise Paracheck Pf RDT QC testing results at Philippines are provided below:




200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control


Quality control dilutions Paracheck Pf Lot: 31670 Paracheck PfLot: 31675



200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control




200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100

200 2 2 100 2 2 100

2000 1 1 100 1 1 100


0 10 10 100 10 10 100

C3F1 (Pf)

C4F2 (Pf)



Negative Control

Quality control dilutions Paracheck Pf Lot: 31049A Paracheck Pf Lot: 31023A



100* 4 4 100 4 4 100

2000 4 4 100 4 4 100


1 1

-

Negative Control


* very low parasitemia at 100 parasites/µl



Tested Positive

200 2 2 100

2000 1 1 100

200 2 2 100

2000 1 1 100

200 2 2 100

2000 1 1 100

200 2 2 100

2000 1 1 100


0 10 10 100

P7F4 (Pf)

P8F9 (Pf)

P7F1 (Pf)

P7F4 (Pf)(Initial testing only)

P8F7 (Pf)(Initial testing only)

Negative Control

Conclusion:

All the Paracheck Pf RDT lots tested at the WHO Lot Testing Centre in Philippines passed the quality control tests for

their sensitivity and specificity and the RDT samples assessed detect antigens at the threshold, SUFFICIENTLY

SENSITIVE FOR USE in the field, even up to 100 parasites / ìl parasite density.


W.H.O./RITM Malaria Rapid Diagnostic Test Quality Assurance InitiativeTemperature Stability Monitoring of Paracheck Pf

The study was conducted at the Research Institute for Tropical Medicine, Alabang, Philippines on 12/12/2002.

The W.H.O./RITM malaria RDT quality assurance initiative monitored the temperature stability of Paracheck Pf RDT Lot No

31042 D, Exp. 09/2004.

Aim:To assess the temperature stability of various malaria rapid tests (RDTs) to allow:

a. Calculation of realistic expiry dates for remote tropical areas.b. Development of parameters suitable for the design of chemical temperature monitoring strips to flag exposure to critical

temperatures.

Background:The malaria RDTs, like many lateral flow tests, are known to be susceptible to heat and humidity. Temperature-sensitive components of the RDT include denaturation of the binding sites of the antibody (Ab), preventing the Ab from binding, antigen (Ag), the wicking properties of the nitrocellulose strip, the integrity of Ab-dye conjugate and adherence of Abs to the nitrocellulose fibres.

Method: 0 0 0 0

The Paracheck Pf device (kits) were stored in incubators set at four different temperatures at 35 C, 40 C, 45 C and 60 C. The RDTs were then retrieved and tested for their sensitivity and specificity against diluted parasitised whole blood samples at

different paracitaemia using QC Lot DN21. The QC samples for testing RDTs were prepared according to the W.H.O. QA SOP 0 0 05.2, using dilution of 50, 100, 150 and 200, 500, 2000 wild parasites/ml. The results for 35 C, 40 C, 45 C were charted on day 2,

04, 10, 20 and 40 and for 60 C at 0, 2, 4, 12, 24 and 48 hours.

The scoring of the intensity of the test band was done as follows: 0= no band, 1+ = weak band, 2+ = medium band, 3+ =

strong band.

Conclusion:0 0 0Paracheck Pf when stressed at elevated temperatures of 35 C, 40 C, 45 C for 40 days, did not show any drop in sensitivity or

0change in specificity. When stored at 60 C for 48 hours no change in Paracheck Pf was observed for low as well as high parasitaemia samples. The dilution of the parasitized blood near the detection limit of the test (200 ml) also were positive throughout the duration of the study.

The results are displayed in the following tables as follows:


0 H

OU

RS

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

4 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

10 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

2+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

20 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

1+3+

Pf

200

1+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

40 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

2+3+

Pf

150

200

2+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

0P

arac

hec

k P

f M

alar

ia R

DT

Tem

per

atu

re S

tab

ility

at

35 C

fo

r a

per

iod

of

0 h

ou

rs, 2

day

s, 4

day

s, 1

0 d

ays,

20

day

s an

d 4

0 d

ays


2 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

4 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

10 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

2+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

20 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

1+3+

Pf

200

2+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

40 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

1+3+

Pf

150

200

1+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

0P

arac

hec

k P

f M

alar

ia R

DT

Tem

per

atu

re S

tab

ility

at

40 C

fo

r a

per

iod

of

2 d

ays,

4 d

ays,

10

day

s, 2

0 d

ays

and

40

day

s


0P

arac

hec

k P

f M

alar

ia R

DT

Tem

per

atu

re S

tab

ility

at

45 C

fo

r a

per

iod

of

2 d

ays,

4 d

ays,

10

day

s, 2

0 d

ays

and

40

day

s

4 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

2+3+

Pf

150

2+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

10 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

2+3+

Pf

150

2+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

2+3+

Pf

150

2+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf


0P

arac

hec

k P

f M

alar

ia R

DT

Tem

per

atu

re S

tab

ility

at

45 C

fo

r a

per

iod

of

2 d

ays,

4 d

ays,

10

day

s, 2

0 d

ays

and

40

day

s

40 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

150

150

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

20 D

AY

S

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

50w

eak

3+P

f

50w

eak

3+P

f

50w

eak

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

200

1+3+

Pf

200

1+3+

Pf

200

1+3+

Pf

500

2+3+

Pf

500

2+3+

Pf

500

2+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf


0P

arac

hec

k P

f M

alar

ia R

DT

Tem

per

atu

re S

tab

ility

at

60 C

fo

r a

per

iod

of

0 h

ou

rs, 2

ho

urs

, 4 h

ou

rs, 1

2 h

ou

rs, 2

4 h

ou

rs a

nd

48

ho

urs

0 H

ou

rs

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

100

2+3+

Pf

150

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2 H

ou

rs

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

50w

eak

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

4 H

ou

rs

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

1+3+

Pf

150

2+3+

Pf

150

1+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf


0P

arac

hec

k P

f M

alar

ia R

DT

Tem

per

atu

re S

tab

ility

at

60 C

fo

r a

per

iod

of

0 h

ou

rs, 2

ho

urs

, 4 h

ou

rs, 1

2 h

ou

rs, 2

4 h

ou

rs a

nd

48

ho

urs

24 H

ou

rs

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

48 H

ou

rs

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

150

1+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

12 H

ou

rs

QC

Lo

tD

iluti

on

Pf

HR

P 2

Co

ntr

ol

Res

ult

Ban

dB

and

DN

210

03+

Neg

501+

3+P

f

501+

3+P

f

501+

3+P

f

100

1+3+

Pf

100

1+3+

Pf

100

1+3+

Pf

150

1+3+

Pf

150

2+3+

Pf

150

1+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

200

2+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

500

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf

2000

3+3+

Pf


Preliminary Summary Results of Malaria RDT Multi-Centre Heat Stability Study, 2004 for Paracheck Pf

Day 0 90 0 90 0 90

Parasite/µL 200 500 1000

RDT 1 Pf 67 7 100 47 100 53

RDT 1 Pan 67 7 100 47 100 53

RDT 2 33 13 100 87 100 100

RDT 4 100 100 100 100 100 100

RDT 5* 100 100 100 100 100 100

The study sponsored by, was conducted in 2004 at the following sites:

· US Centres for Disease Control and Preventions (CDC) USA,

· Hospital for Tropical Disease (HTD), London, UK, and

· Research Institute for Tropical Medicine (RITM), Philippines.

Aim:

The aim of the study was to assess the range of stability to be expected between 5 commercially available products, and the

likelihood that sensitivity may decline in conditions that may be encountered during operational use in tropical countries.


Method: 0 0 0

The malaria RDTs were stored in incubation at three different temperatures namely; 35 C, 45 C and 60 C. The RDTs were

then tested on day 0 and 90 in parallel against identical samples collected and diluted in the Philippines, and stored frozen. All

the products were rated according to the same chart of line intensity used at each site. The mean of of the percentage of

positive lines were then tabulated or plotted for the RDTs on day 0 and 90 for the parasitized blood.

Conclusion:1. Paracheck Pf RDT for malaria was positive for all the dilutions of the parasitized blood namely on day 0 as well as

0 0when it was stored at 37 C for 90 days. Sensitivity of the test was maintained even after storage at 35 C for 90 days.

02. Even when stored at 45 C for 90 days, Paracheck Pf continued to be sensitive to all the dilutions of the parasitized

blood including the lower parasitemia with minimal drop in reactivity.03. Paracheck Pf even if stressed at 60 C for 48 hours continued to remain equally sensitive to all the parasitized

dilutions of the blood without drop in reactivity even after 48 hours.

4. It may be noted that all other brands studied “failed”the thermal stability test.

5. Paracheck Pf is a stable, sensitive and rugged Malaria RDT which is most suitable for operational use in tropical

conditions, without the risk of decline in sensitivity.


oTable 1: Temperature: 35 C. Percentage of positive test lines at day 0 and day 90 for 200, 500 and 1000 parasites/mL. Mean of readings from CDC, HTDL and RITM.

* Paracheck Pf was designated as RDT 5.


Paracheck Pf

Note: Denominator varies where tests were invalid or reading was discontinued after negative RDT readings.Solid line at 80% indicates the cut off point below which RDTs are considered to have failed.

1000 parasites/uL

0

10

20

30

40

50

60

70

80

90

100

0 4 24 48

Time (hours)

% p

os

itiv

e

RDT 1 Pan RDT 1 Pf RDT 2 RDT 4 RDT 5 cutoff 80%

Figure 1C

500 parasites/uL

0

10

20

30

40

50

60

70

80

90

100

0 4 24 48

Time (hours)

% p

os

itiv

e


Figure 1B

Figure 1: Percentage positive test lines on RDTs at the 3 sites.Temperature: 60°C at 0 - 48 hours for 200 (Figure 1A), 500( Figure 1B) and 1000 (Figure1C) parasites/mL (p/mL).

200 parasites/uL

0

10

20

30

40

50

60

70

80

90

100

0 4 24 48

Time (hours)

% p

os

itiv

e


Paracheck Pf

Figure 1A


Paracheck Pf

500 parasites/ mL

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

0 5 10 20 40 90

Time (days)

Tes

t li

ne

inte

nsi

ty

RDT 1 pan RDT 1 pf RDT 2 RDT 4 RDT 5

1000 parasites/ mL

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

0 5 10 20 40 90

Time (days)

Tes

t li

ne i

nten

sity


Figure 2B

Figure 2C

200 parasites/ mL

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

0 5 10 20 40 90

Time (days)

Tes

t li

ne

inte

nsi

ty


Figure 2A

0Figure 2: Test line intensities on test RDTs at the 3 sites. Temperature: 45 C at 0 - 90 days for 200 (Figure 2A), 500 (Figure 2B) and 1000 (Figure 2C) p/µL. Mean of readings from the 3 sites. Note: Denominator varies where tests were invalid or reading was discontinued after negative RDT readings.


Paracheck Pf

Paracheck Pf

Paracheck Pf

200 parasites/mL.

0

20

40

60

80

100

0 10 20 30 40 50 60 70 80 90

Time (days)

% p

os

itiv

e

RDT 1 Pf RDT 1 Pan RDT 2 RDT 4 RDT 5 cutoff 80%

Figure 2A

Figure 2B

Figure 2C

500 parasites/mL.

0

20

40

60

80

100

0 10 20 30 40 50 60 70 80 90

Time (days)

% p

os

itiv

e


1000 parasites/mL.

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70 80 90 100

Time (days)

% p

os

itiv

e


0Figure 3: Percentage positive test lines on RDTs at the 3 sites. Temperature: 45 C at 0 - 90 days for 200 (Figure 3A), 500(Figure 3B) and 1000 (Figure 3C) p/µL. Note: Denominator varies where tests were invalid or reading was discontinued after negative RDT readings. Solid line at 80% indicates the cut off point below which RDTs are considered to have failed.


Paracheck Pf

Paracheck Pf

Paracheck Pf

Internal Stability Studies Conducted for Paracheck Pf0 0

at 2-8 C, R.T., and 45 C

The study was conducted at the R & D department of Orchid Biomedical Systems facility at Verna, Goa India in February 2006.

Aim:0 0The aim of the study was to assess the sensitivity, specificity and stability of Paracheck Pf RDT's at 2-8 C, 20-30 C (R.T.) and

045 C, over 30 months.


Method:0 0

The RDTs were stored in a refrigerator (2-8 C) (freezed and thawed), at room temperature (20-30 C) and an incubator set and 0 0maintained at 45 C for a period of 30 months for lower temperatures and 25 months at 45 C. Each month the RDTs were

retrieved from respective temperature holds and tested in parallel with known P. falciparum negative blood samples, P. vivax positive blood samples and P. falciparum positive blood samples.

The parasite count of Pf positive samples is as under:

1. Pf positive blood sample 1 ~ 3000 parasites/µl. 2. Pf positive blood sample 2 ~ 1500 parasites / µl.

3. Pf positive blood sample 3 ~ 750 parasites / µl. 4.Pf positive blood sample 4 ~ 300 parasites / µl.

5. Pf positive blood sample 5 ~ 100 parasites / µl.

Interpretation of Results: The numbers 1 to 4 are assigned to the intensity of Test bands as compared to Control band. A weak but clearly visible band is defined as 1w. 0 indicates no visible band.

Conclusion:0 0 0

1. Paracheck Pf RDT lots stored at 2-8 C, 20-30 C and 45 C behaved identically for their specificity, sensitivity and reactivity

when stored at these temperatures.0

2. The storage stability claim of Paracheck Pf RDT is enhanced to 4-45 C.



SA

MP

LE

STO

RA

GE

TIM

E (

MO

NT

HS

)

2122

2324

2526

2728

2930

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

2-8

R.T

.45

P. fa

lcip

arum

Neg

. Blo

od s

ampl

e 1

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

P. fa

lcip

arum

Neg

. Blo

od s

ampl

e 2

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

P. fa

lcip

arum

Neg

. Blo

od s

ampl

e 3

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

P. v

ivax

Pos

. Blo

od s

ampl

e 1

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

P. v

ivax

Pos

. Blo

od s

ampl

e 2

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

P. v

ivax

Pos

. Blo

od s

ampl

e 3

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

P. fa

lcip

arum

Pos

. Blo

od s

ampl

e 1

4+4+

4+4+

4+4+

4+4+

4+4+

4+4+

4+4+

4+4+

4+4+

4+4+

3+4

43+

44

2+4

42+

P. fa

lcip

arum

Pos

. Blo

od s

ampl

e 2

3+3+

3+3+

3+3+

3+3+

3+3+

3+3+

3+3+

3+3+

3+2+

3+3+

2+3

32+

33

2+3

31+

P. fa

lcip

arum

Pos

. Blo

od s

ampl

e 3

2+2+

2+2+

2+2+

2+2+

2+2+

2+2+

2+2+

2+2+

2+2+

2+2+

2+2

21+

22

1w2

21w

P. fa

lcip

arum

Pos

. Blo

od s

ampl

e 4

1+1+

1+1+

1+1+

1+1+

1+1+

1+1+

1+1+

1+1+

1+1+

1+1+

1+1

11w

11

01

10

P. fa

lcip

arum

Pos

. Blo

od s

ampl

e 5

1w1w

1w1w

1w1w

1w1w

1w1w

1w1w

1w1w

1w1w

1w1w

1w1w

1w1w

1w0

1w1w

01w

1w0

Inte

rpre

tati

on

of r

esu

lts:

The

num

bers

1 to

4 a

re a

ssig

ned

to th

e in

tens

ity o

f tes

t ban

ds a

s co

mpa

red

to c

ontr

ol b

and.

A w

eak

but c

lear

ly v

isib

le b

and

is d

efin

ed a

s 1w

. 0 in

dica

tes

no v

isib

le b

and.


Rapid Diagnostic Tests (RDT) for the diagnosis of P. falciparum MalariaComparison of validity, reliability and other characteristics of 5 tests in Uganda

The study was conducted at the laboratories of Mbarara Regional Hospital which is also a teaching hospital for the Medical School of Mbarara University of Science and Technology (MUST), Mbarara, Uganda from November 2000 to February 2001. This research was financed by Médecins Sans Frontières (MSF) - France.

Aim:The aim of the study was to select the most appropriate Pf rapid diagnostic test to be used in the field by MSF. A selection of 5 commercially used RDTs to be evaluated were selected on the basis of two main criteria: (a) considering that it is Pf malaria that needs rapid and clear confirmation (more than malaria due to other species), only tests detecting P. falciparum antigens alone were kept; (b) only tests costing 1 dollar or less were included. The specific objectives to be measured for each tests were: (a) Validity (b) Reliability (c) Ease of Use in the field.

Background:Malaria represents a major problem in most of the populations served by MSF. These are often remote areas where microscopic diagnosis is not available and where treatment of malaria is frequently based on clinical diagnosis alone. Malaria RDTs were used for detection of malaria but their use was limited. Selecting an appropriate RDT to be introduced on a large scale needed careful consideration. A study was therefore decided to compare different tests with the objective of selecting the most appropriate malaria RDT to be used in the field. On one had, it would be done in ‘real field conditions’ that is to say in a large sample of patients clinically suspected with malaria attending a health facility. On the other hand, this would be a global evaluation testing not only validity, but also reliability and facility of use in the field.

Method:Blood samples were collected by finger prick from clinically suspected malaria cases. Thin and thick blood films were stained with 2% Giemsa and analyzed under the microscope for the presence of malaria parasites. Results of the blood smear were quantified in parasites/µl. The blood smear was considered as the ‘gold standard’ against which the result of the RDT (positive or negative) was compared.

The 5 tests evaluated detect Pf HRP-II in the blood: BIO P.F. (VEDA LAB, France), Malaria Rapid (Vision Biotech, South Africa), Paracheck Pf Dipstick and Device (Orchic Biomedical Systems, India) and ParaHIT f (Span Diagnostics Ltd., India). The tests were performed according to the manufacturer’s instructions, and read twice after 15 to 30 minutes.

Interpretation of Results:

Objectives Paracheck Pf Paracheck Pf ParaHIT BIO PF Malaria Rapid

Dipstick Device

Validity (Total score = 6) 5 5 5 4 4

Reliability (Total score = 2) 2 2 2 1 1

Ease of use (Total score = 53) 48 46 40 38 44

Conclusion:1. Paracheck Pf RDT dipstick and device were very sensitive for the diagnosis of P. falciparum, especially for levels of

parasitemias above 100 parasites/µl.2. Paracheck Pf RDTs are valid, reliable and seem to be the most appropriate for use in field conditions. For prevalence of

malaria higher than 25% - 30%, they allow to identify malaria infected aptients with a risk of error which is relatively low.


Summary of Paracheck Pf Evaluations

1. MALARIA RESEARCH CENTRE, GOA, INDIASensitivity: 100%Specificity: 100%Comments: The Paracheck Pf test is found to be of high quality in terms of sensitivity, specificity and efficacy.

2. MINISTRY OF HEALTH, DIVISION OF MALARIA CONTROL, KENYATested at Mwea, Makuyu and Nandi North Districts in KenyaSensitivity: 100%Specificity: 100%Comments: The above results data showed that Paracheck Pf based on HRP-II is a reliable and easy to use too for diagnosis where good quality microscopy cannot be maintained. The kits had relatively high sensitivity and thus can be an importatnt screening test for P. falciparum in Kenya where it has 90% occurrence. The sensitivity of Paracheck Pf makes it a good tool for use in IMC clinics in Kenya.

3. INDIAN JOURNAL OF MEDICAL SCIENCE, 2000 OCTOBER; 54(10); 421-4 Tested at Department of Microbiology, Christian Medical College, LudhianaSensitivity: 100%Specificity: 99.5%Comments: The test was 100% sensitive and 99.5% specific on comparison with light microscopy. The test is useful for making on the spot diagnosis.

4. MALARIA JOURNAL 2007 6:58Tested at AMI-KIVU Laboratories, Goma, Democratic Republic of CongoSensitivity:100%Comments: On screening, the Paracheck RDT accurately diagnosed all 235 true malaria cases. The results show that Paracheck Pf is as sensitive as microscopy in detecting true malaria cases.

5. AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE, 72(1), 2005, pp 26-29.Tested at Malaria Research Centre, Jabalpur, Madhya Pradesh, India.Sensitivity: Forest Migrants: 100% Indigenous Population: 100%Specificity: Forest Migrants:: 67% Indigenous Population: 97.3%Comments: The results of the evaluation was very encouraging indicating the usefulness of Paracheck Pf as a diagnostic tool for providing on-site confirmation of symptomatic diagnosis of Plasmodium falciparum malaria.

6. PARACHECK PF (DIPSTICK) TRIAL STUDY FOR MALARIA DIAGNOSIS IN HONIARA, SOLOMON ISLANDS

CONDUCTED BY DR. R VELAYUDHAN, SCIENTIST, WHO, HONIARA, SOLOMON ISLANDSSensitivity: 100%Specificity: 81.4%Comments: Paracheck Pf is a very good detector of P. falciparum infections and is a simple and practical means of rapid diagnosis for P.falciparum malaria. With a high sensitivity and specificity of the test, the present study indicates a threshold of parasite detection at over 120 parasites/ìl of blood. The use of this dipstick requires little technical experience and can be taught to any health worker with one demonstration. In Solomon Islands, such dipsticks can be used for diagnosis of malaria in remote clinics without microscopists, by private practitioners in towns and for emergencies at odd hours in hospitals and clinics. It is more useful in areas with high incidence of falciparum malaria.

7. PATH: WHO COLLABORATING CENTRE FOR RESEARCH IN HUMAN REPRODUCTIONSensitivity: 98.6%Specificity: 98.8%Comments: Orchid's ICT Test for Malaria (Paracheck Pf) is a highly sensitive and specific test for the diagnosis of falciparum malaria.

8. MEDICAL LABORATORY & CLINICAL SCIENTISTS COUNCIL OF ZIMBABWETested at National Microbiology Ref Lab, Kotwa Hospital, Kotwa Clinic, Masarakufa Rural Health Centre, Nyamapanda Rural Health Centre.Sensitivity: 98.3%Specificity: 93.5%Comments: The kit has passed all the technical specifications with respect to WHO standards. It is easy to use and QC of the testing device can be implemented at different levels since it is very stable.The evaluating team recommended the kit for use in Zimbabwe.


9. THE JOURNAL OF INFECTIOUS DISEASES, 2008:197:510-8 (15 FEBRUARY) Tested at San Francisco Malaria Research Collaboration, Kampala, UgandaSensitivity: 98% Specificity: 88% Comments: Based on high PPV and NPV, HRP-II based RDTs are likely to be the best diagnostic choice fro areas with medium to high malaria transmission rates in Africa.

10. ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE (2002) 96, 254-257Tested at Mbarra Regional Hospital, UgandaSensitivity: 97%Specificity: 88%Comments: The Paracheck Pf (dipstick and device) was considered the most appropriate for the use in the field, being sensitive (97%), moderately specific (88%), reliable (kappa coefficient=0.97), easy to use and cheap.

11. ETHIOP MED J. 2008 OCTOBER; 46(4):375-81Tested at College of Health Sciences, Hawassa, EthiopiaSensitivity: Paracheck Pf: 96.7% Parascreen PAN/Pf: 100%Specificity: Paracheck Pf: 76% Parascreen PAN/Pf: 65.1%Comments: Both Paracheck Pf and Parascreen PAN/Pf were found to be effective for the diagnosis of falciparum malaria at peripheral health care unit where skilled personnel and laboratory facilities are not available for blood film examination

12. INDIAN JOURNAL OF PREVENTIVE AND SOCIAL MEDICINE, 2004Tested at Central Malaria Laboratory, Directorate of health and FW Services, Bangalore Sensitivity: 96.1%Specificity: 91.2%Comments: The tests were easy to handle and conduct. In areas where epidemics are reported and where laboratory facilities for microscopic diagnosis are weak, this test application would be of great practical value. The test also holds promise especially in case of private medical practitioners who can conduct the tests themselves without recourse to laboratory.

13. JOURNAL OF PARASITIC DISEASES, 2000 JUNE; 24(1):43-5Tested at Malaria Research Centre, Goa, IndiaSensitivity: 95.8%Specificity: 96.15%Comments: The kit is useful in the routine diagnosis of P. falciparum malaria especially inaccessible hard core areas with predominance of this species.

14. TROPICAL MEDICAL INTERNATIONAL HEALTH 2002, VOLUME 7 NO. 4 PP 304-308 APRIL 2002Tested at National Institute of Malariology, Parasitology and Entomology, VietnamSensitivity: 95.8%Specificity: 100%Comments: Paracheck Pf was the most sensitive test for Plasmodium falciparum (95.8% v/s 82.6% for ICT Malaria Pf/Pv and 49.7% for Optimal).Although mmicroscopy remains the gold standard for malaria diagnosis, Paracheck Pf may prove a useful adjunctive test in uncomplicated falciparum malaria in Southern Vietnam.

15. JOURNAL OF INFECTION 2002 45: 165-168Tested at Bizadandi Primary Health Centre, Mandla Dist., MP, IndiaSensitivity: 94.4%Specifcity: 89%Comments: In this study, Paracheck was found to be as sensitive and specific as thick blood films. Their performance was faster and required less training and equipment. The ability to detect Pf in low numbers may be useful for dry season screening to eliminate reservoirs of infection during wet seasons.

16. TANZANIA JOURNAL OF HEALTH RESEARCH 2008 JAN; 10(1): 14-9 Tested at National Institute for Medical Research, Tanga, TanzaniaSensitivity: 93.1%Specificity: 98.9%Comments: The findings indicate a low prevalence of malaria in Tanga City and that Paracheck Pf, can be an effective tool for malaria diagnosis.


17. THE AMERICAN SOCIETY OF TROPICAL MEDICINE AND HYGIENE; 73(5), 2005, PP 855-858 Tested at Malaria Research Centre, Jabalpur, Madhya Pradesh, IndiaSensitivity: 93%Specificity: 84%Comments: The RDTs for the identification of P. falciparum were more sensitive in Placental blood than the placental blood smear by microscopy. Thus the RDTs should be useful for rapid assessment of malaria at delivery.

18. INDIAN JOURNAL OF MEDICAL MICROBIOLOGY, VOL 24, NO. 1, JANUARY-MARCH, 2006, pp 49-51Tested at Department of Microbiology, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra.Sensitivity: 92.6%Specifcity: 98.6%Comments: HRP-II antigen detection kits are rapid, do not require expertise and can detect P. falciparum infection when the parasites are sequestered, hence are useful in routine diagnosis and in emergency.

19. TROPICAL MEDICINE & INTERNATIONAL HEALTH, VOL 6; NO.2; PG 99-101; FEBRUARY 2001.

Tested at Shoklo Malaria Research Unit, Thailand and Faculty of Tropical Medicine, Thailand.Sensitivity: 92.3%Specificity: 97.2%Comments: The Paracheck Pf. Test based on the detection of the P. falciparum specific HRP-II protein is a reliable, easy to use and affordable tool for the diagnosis of P. falciparum malaria.

20. THE AMERICAN SOCIETY OF TROPICAL MEDICINE AND HYGIENE: 75(6); 2006, pp 1209-1215Tested at Malaria Center, Zona Atlantica, ColumbiaSensitivity: 90.8%Specificity: 99.5%Comments: Paracheck Pf and NOW Malaria ICT were more accurate in detecting P. falciparum malaria in comparison with Optimal IT. Paracheck Pf, a P. falciparum specific test based on the detection of parasite HRP-II has proven its accuracy and usefulness in many MSF projects worldwide.

21. ANN TROP MED PARASITOL 2006 MARCH; 100(20):115-22Tested at National Institute for Medical Research, Dar es Salaam, TanzaniaSensitivity: 90%Specificity: 96.6%Comments: The overall measurements of the assay's performance were good, the assay was easy to perform in the field and could clearly be a valuable tool in remote areas and in emergency situations, such as the early detection of malaria outbreaks.

22. ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE (2003) 97, pp. 672-674Tested at Shoklo Malaria Research Unit, ThailandSensitivity: 89.9%Specificity: 95.7%Comments: Rapid diagnostic tests offer a good alternative diagnostic tool in areas where reliable microscopy is not present Paracheck Pf detected 100% of 500-5000 parasites/ìl, 90% of 100-500 parasites/ìl and 20% of < 100 parasites/ìl

23. MJAFI 2004; 60: 137-141 Comments: Paracheck Pf ICT was found to have enormous advantages over smear examination due to its high degree of sensitivity, specificity, speed and ease of performance. Paracheck Pf is stable at room temperature, Regimental Medical Officers and nursing assistants with minimal training can safely practice Paracheck Pf ICT method. Introduction of this test kit in the Armed forces can facilitate early diagnosis and specific treatment of P. falciparum malaria even at far flung places. This will have enormous beneficial effect in reducing morbidity due to malaria and saving precious lives. In short as well as long term, it is a viable cost effective option.

24. EPICENTRE MSF ORG. Rapid Diagnostic Tests (RDT) for the diagnosis of P. falciparum malaria. Comparison of validity, reliability and other characteristics of 5 tests. Tested at Mbarra, Uganda, November 2000 - February 2001.Comments: Paracheck Pf dipstick and device... were highly reliable. They were sensitive for the diagnosis of P. falciparum especially for levels of parasitemia above 100 parasities /ìl.

25. Am. J. Trop. Med. Hyg. (76) 6, 2007, PP. 1092 - 1097.Sensitivity: 92 - 95%.Specificity: 93%.Comments: As compared with microscopy, both HRP-II and pLDH based RDTs demonstrated acceptable sensitivity and specificity for the diagnosis of malaria in Kampala... The difference in sensitivity between the tests was due mostly to better detection with HRP-II at low parasite densities.


Bibliography

1. Summary of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centres in Cambodia and

Philippines.

2. Details of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centre in Cambodia.

3. Details of Quality Assurance Reports of Paracheck Pf RDTs at the W.H.O. Lot Testing Centre in Philippines.

4. W.H.O./RITM Malaria Rapid Diagnostic Test Quality Assurance Initiative Temperature Stability Monitoring of Paracheck Pf.

5. Preliminary Summary Results of Malaria RDT Multi-Centre Heat Stability Study, 2004 for Paracheck Pf.0 0

6. Internal Stability Studies Conducted for Paracheck Pf at 2-8 C, R.T. and 45 C.

7.

All these reports are archived at the Orchid Biomedical Systems QA reference data base and can be obtained on request via e-

mail.

Rapid Diagnostic Tests (RDT) for the diagnosis of P. falciparum Malaria Comparison of validity, reliability and other

characteristics of 5 tests in Uganda.


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