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 18 (HIV-1/2 antibodies rapid diagnostic tests)
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
- EBOLA IVDs
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
ZIKA VIRUS: Emergency Use Assessment and Listing Procedure (EUAL) announcement
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to email@example.com no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
Newsletter Issue 12, Q4 2015
Guidance for post-market surveillance
Prioritization criteria expanded to HPV