1 · web view2019/05/03 · the c line serves as a built-in internal control and gives...

CGH/DGHT – International Laboratory Branch – Atlanta, GA

1.0 TITLE Maxim Swift™ HIV Recent Infection Assay (RIA)

2.0 PURPOSE

2.1 Clinical Significance2.1.1 The Maxim Swift HIV RIA is a single use rapid in vitro immunoassay that

can detect the circulating antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), Type 2 (HIV-2) and distinguish between recent and long-term infection in HIV-1 using a single test device.

2.2 Biological Principles of the Procedure2.2.1 The Maxim Swift HIV RIA is a portable, rapid lateral flow type of format

using antibody binding protein A, which is conjugated to colloidal gold dye particles as conjugate, and HIV antigens (rIDR-M, an antigen which contains the major variants of gp41 immunodominant regions among the HIV-1 group M viruses; HIV-1 (gp41); HIV-2 (gp36)), which are bound to the membrane solid phase. The specimen is mixed with the running buffer and this mixed sample is added into the cassette’s sample well and absorbed into the test’s sample pad to initiate the test run.

2.2.2 The sample mixture migrates by a wicking action until it rehydrates the protein A-gold colloid conjugate, conferring a reddish-purple to purplish-gray coloration which will bind to both HIV-positive (if present) and HIV negative antibodies in the specimen liquid.

2.2.3 The colored liquid will continue to move up the Test Cassette onto the nitrocellulose membrane which contains three reagent lines (in order of sample contact: Long-Term line [marked “LT” position], Test line [marked “T” position] and Control line [marked “C” position]).

2.2.4 In a reactive sample, the user will see a reddish-purple to purplish-gray liquid mixture migrate up the Test Cassette in the test window.2.2.4.1 As the liquid containing antibodies bound to the conjugate crosses

the membrane, it first encounters the LT position, which contains the HIV-1 rIDR-M recombinant antigen.

2.2.4.2 The liquid specimen continues to migrate up the Test Cassette, next encountering the T position, which contains gp41 and gp36 recombinant antigens which will bind any HIV-1 and HIV-2 antibodies present in the specimen.

2.2.4.3 Finally, the liquid specimen will continue to migrate up the cassette, encountering the C position. The control will bind human antibodies in the liquid regardless of whether those antibodies are HIV positive or negative.

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3.0 SCOPE

3.1 The assay will serve as a supplemental test for specimens that are already confirmed as HIV positive

3.2 The assay and results obtained from the Maxim Swift HIV RIA will not change country specific guidelines on HIV care and treatment. It is for research use only for the real-time monitoring of the epidemiology of recent infections which will help allow countries to target the public health response to sub-populations and locations where high levels of transmission may be occurring. Hence, it is not intended for use in diagnostic procedures or for determining clinical outcome or treatment.

3.3 The assay is intended for use with whole blood, serum or plasma specimens as either a laboratory or point of collection test to detect recent infections.

4.0 RESPONSIBLILITIES

4.1 Serology/Incidence Laboratory Staff4.1.1 Stores unopened Maxim Swift HIV RIA kits at the manufacturer

recommended temperature (4-30°C).4.1.2 Prepares and manages specimens for testing appropriately.4.1.3 Performs Maxim Swift HIV RIA according to manufacturer’s instructions.4.1.4 Documents and reviews test result.4.1.5 Completes the ILB600FXXA Maxim Swift HIV RIA Result Form and

submit results for review prior to reporting.4.1.6 Notifies Serology/Incidence Team Lead of QA/QC failure.

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The Maxim Swift HIV RIA cassette contains the Long-Term line (LT), Test line (T) and Control line (C).


4.1.7 Complies with remedial/corrective action when necessary to ensure accurate and reliable test result.

4.2 Serology/Incidence Team Lead4.2.1 Oversees the Maxim Swift HIV RIA in Serology/Incidence Laboratory.4.2.2 Reviews Maxim Swift HIV RIA results and documentations.4.2.3 Provides feedback to the laboratorian if necessary.4.2.4 Investigates QA/QC failures or issues and provide remedial/corrective

action where necessary.4.2.5 Provides a designee for Team Lead responsibility during absence.

5.0 REAGENTS

5.1 Kit Components:5.1.1 Test kit – manufacturer Maxim (Catalog # 92002; 20 test/kit)

Identification on Label Description PresentationTest Cassette Nitrocellulose membrane containing

HIV-1 and HIV-2 recombinant antigens in TEST area, protein A in CONTROL area, and protein A-gold colloid conjugate in BUFFER well area

20 x 1Ready to use

Running Buffer Vials of running buffer in sample tube 1 x 20 Ready to use

Capillary Transfer Pipettes 2µl for serum/plasma samples (clear bag) 1 x 23 Ready to use

5µl for blood samples (pink bag) 1 x 23 Ready to use

5.2 Storage Requirements5.2.1 Unused Maxim Swift HIV RIA kits and devices may be stored unopened

at 4-30°C until the product expiration date. 5.2.2 If removing tests from 4-8°C storage, ensure test kits are at room

temperature before starting.5.2.3 Do not open the pouch until performing a test.

5.3 Assay controls5.3.1 Store controls at -20°C.5.3.2 Bring controls to room temperature (18 - 30°C) before use. Return

controls to 2-8°C after use. 5.3.3 In-house controls

5.3.3.1 Negative - one vial (100µl)5.3.3.2 Recent Infection - one vial (100µl)5.3.3.3 Long-Term Infection – one vial (100µl)

5.3.4 Optional: Maxim Swift HIV RIA external controls are commercially available (P/N: 92002-C, Maxim Swift™ HIV RIA Kit Control).

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5.3.4.1 This kit contains 3 vials representing 1) HIV long-term infection, 2) HIV recent infection, and 3) a negative specimen.

6.0 EQUIPMENT

6.1 Laboratory Timer6.2 Centrifuge6.3 Vortex (optional)6.4 Micropipette (optional)

7.0 SUPPLIES

7.1 Materials provided (please see 5.1.1)7.1.1 Device (20 units)7.1.2 Running buffer (20 micro tubes)7.1.3 Capillary transfer pipettes (1 x 23; 2 pouches total)

7.2 Materials required but not provided:7.2.1 Lancet/phlebotomy supplies for blood collection7.2.2 Rack for 2 ml micro tubes7.2.3 Absorbent pads or paper towels7.2.4 Biohazard bags7.2.5 Personal Protective Equipment (lab coat/apron, disposable gloves, eye

protection)7.2.6 Pen or permanent maker7.2.7 10% bleach solution or 70% ethanol7.2.8 Pipette tips (optional)

8.0 SAMPLE

8.1 Whole Blood8.1.1 Fingerstick and venous whole blood are acceptable. 8.1.2 Venous blood should be collected by conventional phlebotomy methods

8.1.2.1 EDTA or ACD anticoagulants should be used in blood collection. 8.1.2.2 Do not use Heparin anticoagulant.

8.2 Serum or Plasma8.2.1 Serum/plasma should be separated from whole blood cells using a

centrifuge (3000 rpm for 10 minutes) within 24 hours of collection.

8.3 Specimen storage8.3.1 Blood specimens to be stored for longer than 24 hours should be converted

to serum or plasma and stored frozen.8.3.2 Serum/Plasma may be stored at 2-8°C for 7 days.8.3.3 Long term storage specimens (serum/plasma) should be frozen (-20°C or

colder).

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8.3.4 Do not use specimens if greater than 5 freeze-thaw cycles. Mix samples thoroughly after thawing.

8.4 Labeling and Identification8.4.1 Specimens arriving in the laboratory must have an original identifiers

affixed to the specimen.8.4.2 CDC Specimen ID (CSID) and CDC unique ID (CUID) are assigned and

affixed to each specimen by the laboratory staff.8.4.3 Specimen may be frozen and thawed up to 5 times.

8.5 Specimen shipment8.5.1 Ship specimens in compliance with Federal Regulations covering the

transportation of etiologic agents.8.5.2 For shipments that are in transit for up to 7 days, maintain at 2-8°C by

using cold packs.8.5.3 For shipments that are in transit for greater than 7 days, maintain

temperature at -20°C or colder by using dry ice.

8.6 Unacceptable Specimens8.6.1 Specimens improperly labeled or unlabeled.8.6.2 Specimens with insufficient volume for testing.8.6.3 Specimens without documentation or with discrepant documentation.8.6.4 Specimens improperly collected or preserved.8.6.5 Specimens that have leaked in transit or otherwise show evidence of

contamination.8.6.6 Lipemic, hemolyzed or microbially contaminated blood, serum or plasma

9.0 SPECIAL SAFETY PRECAUTIONS

9.1 Do not drink, eat, smoke, or apply cosmetics while handling specimens.9.2 Practice universal precautions when handling whole blood, serum or plasma

specimens and unused assay components. 9.3 This test kit should be handled only by adequately qualified personnel trained in

laboratory procedures and familiar with their potential hazards.9.4 Wear gloves, a lab coat, and eye protection when handling specimens or materials

exposed to blood or blood components. Wash hands thoroughly after handling specimens and tests. Use of disposable gloves is recommended.

9.5 Used gloves and test supplies should be discarded as hazardous waste after use.9.6 Syringes and other sharps should be disposed of in a puncture-resistant container

prior to disposal as hazardous waste.9.7 Wipe all work areas before and after testing with an appropriate chemical

disinfectants such as 10 % household bleach or 70% Ethanol. Wipe all spills thoroughly with disinfectant.

10.0 QUALITY CONTROL

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10.1 External Controls (Plasma)

10.1.1 Use in-house controls when testing specimens10.1.1.1 Negative10.1.1.2 Recent Infection10.1.1.3 Long-Term Infection

10.1.2 Controls → Run one HIV long-term infection, HIV recent infection, and a negative specimen

10.1.3 It is recommended to perform the controls under the following circumstances:10.1.3.1 With each assay run10.1.3.2 When opening a new test kit lot.10.1.3.3 Whenever a new shipment of test kits is received.

10.2 Control Storage

10.2.1 Store at -20°C.10.2.2 Bring controls to room temperature (18 - 30°C) before use. 10.2.3 Return controls to -20°C after use.10.2.4 Controls may be frozen and thawed up to 5 times.

10.3 Built-in Control Feature

10.3.1 The C line serves as a built-in internal control and gives confirmation of sample addition and proper test performance.

10.3.2 A reddish-purple to purplish-gray line will appear in the C position, regardless of whether the T line or LT line gives a reactive or non-reactive result, if the test has been performed correctly and the device is working properly (Please see 16.0 Interpretation/Results).

10.3.3 If a reddish-purple to purplish-gray C line does not appear, the test is “invalid”.

10.4 Record data in the ILB600FXXA Maxim Swift HIV RIA Result Form.10.5 File an ILB-100-F25A Occurrence Management Form for any QC failure.

11.0 WORKFLOW CHART – N/A

12.0 PROCEDURE

12.1 Preliminary Statements

12.1.1 Read the Product Insert completely before using this assay. Follow the instructions carefully as not doing so may result in inaccurate test results.

12.1.2 Use of this test kit with sample types other than those specifically approved for use with this device may result in inaccurate test results.

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12.1.3 This test should be performed at 20°C to 30°C. If stored refrigerated, allow the Test Set to come to ambient or room temperature (20-30°C) before running the test.

12.1.4 DO NOT USE the test device if there is no desiccant packet in the device pouch. Discard the test device and use a new device from a pouch that contains a desiccant.

12.1.5 DO NOT USE the test device if the device pouch is damaged.12.1.6 Each test component (Test Cassette, Running Buffer and Capillary

Transfer Pipette) is intended for a single use. Do not use more than once. If a test must be repeated, use all new components for the retest.

12.1.7 Check the expiration date of the kit and each dated component (Test Cassette and Running Buffer) prior to use. Do not use any materials after the expiration date printed on the material’s package labeling.

12.1.8 Test Cassettes and Running Buffer tubes are matched to work with each other in each kit. Do not interchange or use Running Buffer and Test Cassettes from different lots or kits.

12.1.9 Avoid handling kit components to minimize contamination. Avoid handling the read area (i.e. membrane) of the Test Cassette.

12.1.10 Do not open the Test Cassette pouch packaging until ready to perform a test.

12.1.11 After performing the test, read Test Cassette visually using adequate lighting to ensure accurate results.

12.2 Testing Procedure

12.2.1 Label the buffer micro tubes with the client ID facing toward the operator and place the buffer tubes in a micro tube rack. Do not test more than 5 (for beginners) or 10 (for experts) in a batch.

12.2.2 Remove the cap from the Running Buffer tube and discard.12.2.3 Collect serum/plasma (using the 2 µL Capillary Transfer Pipette) or blood

(using the 5 µL Capillary Transfer Pipette) specimen by dipping the tip of the capillary transfer pipette into the specimen (see diagram below).

12.2.3.1 When removing the Capillary Transfer Pipette from the bag, avoid touching the tip of the pipette.

12.2.3.2 Do not squeeze the bulb of the Capillary Transfer Pipette. The sample should flow to the appropriate 2µL/5µL marking via capillary action.

12.2.3.3 Note that there are two types of Capillary Transfer Pipettes: 2µL and 5µL in two different packs.

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12.2.3.4 Visually inspect the Capillary Transfer Pipette to ensure that it is filled to the line with specimen. (Alternatively, a micropipette may be used to transfer the specimen).

12.2.4 Transfer the specimen from the Capillary Transfer Pipette directly into the appropriately pre-labeled buffer tube.

12.2.5 Gently squeeze and release the bulb of Capillary Transfer Pipette 3-4 times to thoroughly mix the specimen into the Running Buffer tube.12.2.5.1 Minimize the introduction of air bubbles into the buffer as

much as possible while mixing. 12.2.5.2 Keep the Capillary Transfer Pipette in the Running Buffer

tube until ready to add to the Test Cassette. Do not throw away Capillary Transfer Pipette until it has been used to transfer the diluted specimen into the Test Cassette.

12.2.6 Open the foil pouch containing the Test Cassette and remove the Test Cassette. Check to see that there is a desiccant packet inside the foil pouch. If no desiccant packet is present, discard and obtain another Test Cassette.

12.2.7 Squeeze the bulb of the Capillary Transfer Pipette (from step 12.2.5) and draw the prepared diluted specimen sample to the 100µL marking. Avoid drawing any air bubbles into the Capillary Transfer Pipette.

12.2.8 Add the 100 µL of diluted specimen to the sample well of the Test Cassette.

12.2.9 Allow test to run for exactly 20 minutes before reading the results.12.2.10 Read the test results on the Test Cassette visually within 5 minutes.

Note: it is important to read results within the allotted time specified. 12.2.11 Please see 16.0 Interpretation/Results for instructions on how to

read and interpret results. 12.2.12 After reading the results, dispose of the used Test Cassette and

Buffer Tube in accordance with Universal Precautions.

12.3 Recording of Results

12.3.1 Use ILB600F19A Maxim Swift HIV RIA Result Form to document QC and test results performed.

13.0 METHOD PERFORMANCE SPECIFICATIONS

13.1 Test Validation Criteria

13.1.1 Band reactivity - All visible bands. Even a faint band must be considered as reactive.

13.1.2 Valid - A test is valid only if a reddish-purple to purplish-gray line appears in the control (C) area, whether the T line or LT line gives a reactive or non-reactive result.

13.1.3 Invalid - If a reddish-purple to purplish-gray line does not appear in the control (C) area, the test is invalid.

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NOTE: An invalid test cannot be interpreted. It is necessary to repeat sample testing with a new device.

13.2 Maxim Swift HIV RIA validation study results.

13.2.1 Sensitivity and specificity of the Maxim Swift HIV RIA was conducted on a specimen panel consisting of 1500 samples using reference data from standard diagnostic testing algorithm (EIA/Western Blot) and the LAg-Avidity for classification of recent infection.

13.2.2 Overall performance of the Maxim Swift HIV RIA with the standard diagnostic algorithm was 99.31% (95% CI: 98.24-99.81) for sensitivity and 99.56 (95% CI: 98.89-99.88) for specificity, with an overall agreement of 99.47 (Kappa=0.989 [0.981-0.997].

13.2.3 The Maxim Swift HIV RIA has similar performance with classifying recent infections (88.9%, kappa = 0.628).

13.3 Test Limitations

13.3.1 Maxim Swift HIV RIA must be used according to the instructions in this product insert to obtain accurate results.

13.3.2 Results must be read between 20 and 25 minutes after adding the diluted specimen into the sample well of the Test Cassette. Reading results outside of this window may give inaccurate results.

13.3.3 Maxim Swift HIV RIA is for Research or Surveillance Use Only. It is not intended for diagnostic use. The assay is intended for use only with serum/plasma or blood collected as described.

13.3.4 The Mean duration of Recent infection (MDRI) for this assay is targeted to match that of the Maxim LAg-Avidity EIA (about 180 days).

13.3.5 The false recency rate (FRR) of this assay is likely to be similar to LAg-Avidity EIA. This value will vary depending on state of the epidemic, ART coverage, and duration of ART. However, it can be mitigated by exclusion of persons on ART or elite controllers and addition of viral load as part of the recent infection testing algorithm.

13.3.6 Persons with diagnosis of AIDS or low CD4+ T cell counts (below 200 cells per μL), recipients of anti-retroviral therapy and known “elite controllers” (HIV-infected individuals with known low or undetectable viral loads) should be excluded from population studies to reduce the likelihood of misclassification of recent of infection.

13.4 Assay Interpretation Limitations

13.4.1 A faint LT line should be interpreted as long-term. Different interpretations of a faint third line (long-term line) are acceptable. The third line (long-term line) measures the evolving antibody avidity and a person could truly be at the transition between having a recent and long-

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term infection and therefore the test would show a faint third line (long term line).

13.4.2 A result with only the C line, i.e., HIV-negative, is very rare. If it does occur, the test should be repeated and the results recorded. 13.4.2.1 If the same result is obtained upon repeat testing, the

specimen should be reflexed to the ILB-200-P19 Geenius HIV-1/2 Supplemental Assay for confirmatory testing.

13.4.3 Prior studies and UNAIDS/WHO now recommend that, where possible, viral load testing should be incorporated into a recent infection testing algorithm incorporating serological assays to measure HIV incidence to reduce the FRR in HIV incidence estimates. If viral load testing is performed on specimens tested with the Maxim Swift HIV RIA, specimens classified as “Recent” by this assay but which have a viral load <1,000 copies/mL should be reclassified as “Long Term” infection.

14.0 CALCULATIONS – N/A

15.0 REFERENCE INTERVALS – N/A

16.0 INTERPRETATION/RESULTS

16.1 Reactivity - All visible lines. Even a faint line must be considered as reactive.

16.2 Validation Criteria

16.2.1 Valid - A test is valid only if a reddish-purple to purplish-gray line appears in the control (C) position, whether the T line or LT line gives a reactive or non-reactive result.

16.2.2 Invalid - If a reddish-purple to purplish-gray line does not appear in the control (C) position, the test is invalid. NOTE: An invalid test cannot be interpreted. It is necessary to repeat sample testing with a new device.

16.3 Interpretation Criteria

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Long-Term infection

Recent infection

Negative infection


16.3.1 Long-Term infection16.3.1.1 A sample is considered long-term when all three reactive

lines appear as reddish-purple to purplish-gray lines, i.e., the Control line (C), the Test line (T), and the Long-Term line (LT) should all be visible. The figure below shows an example of a Long-Term infection test result.

16.3.2 Recent infection16.3.2.1 A sample is considered a recent infection when the C line

and T lines are both visible as reddish-purple to purplish-gray lines, but the bottom LT line is not. The figure below shows an example of a Recent infection.

16.3.3 Negative result16.3.3.1 A sample is an unconfirmed negative when only the C line

appears as reddish-purple to purplish-gray lines, and the T and LT lines. A sample giving a negative result should be confirmed with an approved HIV Diagnostic Test. The figure below shows an example of a negative result.

16.3.4 Invalid test16.3.4.1 The figure below shows several examples of Invalid test

results. A test result is considered invalid:

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16.3.4.1.1 If the C line does not appear as a reddish-purple to purplish-gray line, regardless of the presence or absence of any other lines.

16.3.4.1.2 If the LT line is present as a reddish-purple to purplish-gray line, but the T line is absent, the results are also invalid.

16.3.4.2 Specimens that give invalid results should be retested with all new components.

17.0 RESULTS REVIEW AND APPROVAL

17.1 The Serology/Incidence Team Lead will review and approve the completed ILB600F19A Maxim Swift HIV RIA Result Form

17.2 Upon completion of testing and review, the laboratory data is stored in the OID ELIMS, share drive, and/or appropriate binder located in the Incidence Laboratory.

18.0 REPORTING RESULTS/GUIDELINES FOR NOTIFICATION

18.1 The Serology/Incidence Team Lead or designee will review and approve allresults prior to reporting.

19.0 SAMPLE RETENTION AND STORAGE – N/A

20.0 REFERENCES

20.1 Yufenyuy, E.L., Detorio, M., Tan, X. (2019). Evaluation of Rapid Tests for Recent HIV Infection: Implications for Real-time Surveillance and Epidemic Control. CROI 2019. Seattle, U.S.A. Mar 4-7, 2019. Poster #42.

20.2 Centers for Disease Control and Prevention (CDC) Universal Precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. MMWR 1988; 37(24):377-388.

20.3 Kanki, P.J., Hopper, J.R. and Essex, M. (1987) The origins of HIV-1 and HTLV-4/HIV/2. Ann N Y Acad Sci 511: 370-375.

20.4 Nicoll, A., Gill, O.N. (1999) The global impact of HIV infection and disease. Commun Dis Publ Health 2: 85-95.

20.5 Valdiserri R.O., Holtgrave, D.R., West, G.R. (1999) Promoting early diagnosis and entry into care. AIDS 13: 2317-2330

20.6 Gallo RC, Salahuddin SZ, Popovic M, et al: Frequent detection and isolation of cytopathic retroviruses (HTLV-III) from patients with AIDS and at risk for AIDS. Science 224:500-503, 1984

20.7 Janssens W, Buvé A, Nkengasong JN: The puzzle of HIV-1 subtypes in Africa. AIDS 11:705-712, 1997. 21.

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20.8 Charneau P, Borman AM, Quillant C, et al: Isolation and envelope sequence of a highly divergent HIV-1 isolate: definition of a new HIV-1 group. Virology 205:247-253, 1994.

20.9 Simon F, Mauclère P, Rogues P, et al: Identification of a new human immunodeficiency virus type 1 distinct from group M and group O. Nature Medicine 4:1032-1037, 1998.

20.10 Gao F, Yue L, Robertson DL, et al: Genetic diversity of human immunodeficiency virus type 2: evidence for distinct subtypes with differences in virus biology. J Virology 68:7433-7447, 1994.

20.11 George JR, Rayfield M, Philips S, et al: Efficacies of U.S. FDA-licensed HIV-1 screening enzyme immunoassays for detecting antibodies to HIV-2. AIDS 4:321-326, 1990.

20.12 Janssen RS, Satten GA, Stramer SL, et al. New testing strategy to detect early HIV-1 infection for use in incidence estimates and for clinical and prevention purposes. JAMA 1998, 280:42-48 [Erratum JAMA 1999, 281:1893]

20.13 Kothe D, Byers RH, Caudill SP, et al. Performance characteristics of a new less sensitive HIV-1 enzyme immunoassay for use in estimating HIV seroincidence. J Acquir Immune Defic Syndr 2003, 33:625-634.

20.14 Diza RS, Kallas EG, Castelo A, Rawal BD, and Busch MP. Use of a new ‘less-sensitive enzyme immunoassay’ testing strategy to identify recently infected persons in a Brazilian prison: Estimation of incidence and epidemiological tracing. AIDS 1999, 13:1417-1418.

20.15 McFarland W, Busch MP, Kellogg TA, et al. Detection of early HIV infection and estimation of incidence using a sensitive/less-sensitive enzyme immunoassay testing strategy at anonymous counseling and testing sites in San Francisco. J Acquir Immune Defic Syndr 1999, 22:484-489.

20.16 Sill AM, Kreisel K, Deeds BG et al. Calibration and validation of an oral fluid-based sensitive/lesssensitive assay to distinguish recent from established HIV-1 infections. J Clin Lab Anal 2007. 21:40-45.

20.17 Constantine NT, Sill AM, Jack N, et al. Improved classification of recent HIV-1 infection by employing a two-stage sensitive/less-sensitive test strategy. J Acquir Immune Defic Syndr 2003, 32:94-103.

20.18 Young CL, Hu DJ, Byers R, et al. Evaluation of a sensitive/less sensitive testing algorithm using the bioMerieux Vironostika-LS assay for detecting recent HIV-1 subtype B’ or E infection in Thailand. AIDS Res Hum Retroviruse 2003, 19:481-486.

20.19 Parekh BS, Hu DJ, Vanichseni S, et al. Evaluation of a sensitive/less-sensitive testing algorithm using the 3A11-LS assay for detecting recent HIV seroconversion, among individuals with HIV-1 subtype B or E infection in Thailand. AIDS Res Hum Retroviruses 2001, 17:453-458.

20.20 Parekh BS, Kennedy MS, Dobbs T, et al. Quantitative detection of increasing HIV type 1 antibodies after seroconversion: a simple assay for detecting recent HIV infection and estimating incidence. AIDS Res Hum Retroviruses 2002, 18:295-307.

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20.21 Sakarovitch C, Rouet F, Murphy G, et al. Do tests devised to detect recent HIV-1 infection provide reliable estimates of incidence in Africa? J Acquir Immune Defic Syndr 2007, 45:115-122.

20.22 Karita E, Price M, Hunter E, Chomba E, Allen S, et al. Investigating the utility of the HIV-1 BED capture enzyme immunoassay using cross-sectional and longitudinal seroconverter specimens from Africa. AIDS 2007, 21:403-408.

20.23 Barnighausen T, Wallrauch C, Welte A, McWalter TA, Mbizana N, et al. HIV incidence in rural South Africa: comparison of estimates from longitudinal surveillance and cross-sectional cBED assay testing. PLoS ONE 2008, 3(11):e3640.

20.24 Guy R, Gold G, Garcia Callega JM, Kim AA, Parekh B et al. Accuracy of serological assays for detection of recent infection with HIV and estimation of population incidence: a systematic review. Lancet Infect Dis 2009, 9:747-759.

20.25 Wei X, Liu X, Dobbs T, Kuehl et al. Development of two avidity-based assays to detect recent HIV type 1 seroconversion using a multi-subtype gp41 recombinant protein. AIDS Res Hum Retroviruses 2010, 26:1-11.

20.26 Parekh B, Duong Y, Mavengere Y, et al. Performance of new LAg-Avidity EIA to measure HIV-1 incidence in a cross-sectional population: Swaziland HIV Incidence Measurement Survey (SHIMS). XIX International AIDS Conference. Washington DC. July 22-27, 2012. Abstract #LBPE27.

20.27 Kassanjee R, Pilcher CD, Keating SM, et al. Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository. AIDS 2014, 28:2439-2449.

20.28 Duong YT, Kassanjee R, Welte A, et al. Recalibration of the Limiting Antigen Avidity EIA to determine mean duration of recent infection in divergent HIV-1 subtypes. PLoS ONE 2015, 10(2): e0114947.

20.29 UNAIDS/WHO Working Group on Global HIV/AIDS and STI surveillance. Technical update on HIV incidence assays for surveillance and monitoring purposes. Geneva: WHO. 2015.

20.30 World Health Organization (WHO). When and how to use assays for recent infection to estimate HIV incidence at a population level. Geneva: WHO. 2011.

20.31 Office of the Global AIDS Coordinator (OGAC). Update on HIV-1 incidence estimation and surveillance in resource-constrained settings using tests for recent infection—Statement from the Surveillance and Survey and the Laboratory Technical Working Groups to the Office of the Global AIDS Coordinator, Washington DC: OGAC. September 2010.

20.32 McWalter TA and Welte A. Relating recent infection prevalence to incidence with a sub-population of assay non-progressors, Journal of Mathematical Biology 2010, 60(5):687-710.

21.0 RELATED DOCUMENTS21.1 Maxim Swift HIV Recent Infection Assay Product Insert. August 2017.21.2 ILB-200-P19 Geenius HIV-1/2 Supplemental Assay

22.0 APPENDICES22.1 ILB-600-FXXA Maxim Swift HIV RIA Result Form

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22.2 ILB-600-GXXA Maxim Swift HIV RIA Job Aid22.3 ILB-100-F25 Occurrence Management Form

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