In vitro diagnostics and laboratory technology

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.

Past evaluations

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.

Related documents

Related links

External web sites

Emergency Use Assessment And Listing (EUAL) Procedure


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Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211, Geneva 27