HIV test kit evaluations
Laboratory diagnosis of HIV infection generally focuses on detection of antibody to HIV. However, the new generation assays also incorporate HIV antigen detection to increase the sensitivity of the assay. In this way, a HIV antigen-antibody combination assay is helpful in closing the window period (the time between HIV infection and appearance of antibodies to HIV) as HIV antigen is present in the blood before antibodies to HIV can be detected.
Composition of the panel
Test kit evaluations are carried out at the WHO Collaborating Centre in Antwerp, on the WHO HIV reference panel of well characterised serum/plasma specimens of geographically diverse origin, seroconversion panels and low titer panels. This approach allows for comparative data. In addition, field evaluations are occasionally conducted.
Other specimen types
Assessment of the performance of test kits recommended for use with other specimens types such as whole blood, oral fluid and urine, are carried out in prospective studies as these samples can not be stored. Some of these tests may be useful for VCT testing settings and hard to reach populations.
In recent years, 29 assays for the detection of HIV antibody have been evaluated, of which 19 were simple rapid tests and 5 tests were combined HIV antigen-antibody ELISAs.
HIV Assays Report 17 (HIV rapid diagnostic tests)
HIV Assays Report 16 (Rapid Tests)
HIV Assays Report 15 (Antigen/Antibody Tests)
HIV Assays Report 14 (Simple/Rapid Tests)
HIV Assays Report 13 (Urine and Saliva Tests)
HIV Assays Report 12 (Whole Blood Tests)
HIV Assays Report 11
External web sites
Circonstances et modalités d’utilisation des tests d’infection récente pour estimer l’incidence de l’infection à HIV au niveau d’une population.
When and how to use assays for recent infection to estimate HIV incidence at a population level
HIV Rapid Assays: Operational Characteristics Report 16
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- WHO Prequalification of Medicines, Diagnostics and Vaccines: 6th Consultative Meeting with Stakeholders, 4-5 April 2011
- WHO Technical Working Group Meeting on CD 4 Technologies,17 -19 November 2009
- WHO Technical Working Group Meeting on Prequalification of HIV Virological Technologies, 21-23 September 2009
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