HIV Rapid Diagnostic Tests for HIVST

Diagnostics for HIV self-testing

The OraQuick® In-Home HIV Test is the only rapid diagnostic test (RDT) for HIV that is currently approved by the United States Food and Drug Administration (FDA) for HIVST. For details on this approval process, see the US FDA Summary of Safety and Effectiveness Report and the OraSure website.

The BioSURE® HIV Self Test is the only self-test for HIV approved for sale in the UK. The autotest VIH® is the only self-test for HIV approved for sale in France (planned to begin sale in France September 2015 and other EU countries in late 2015/2016). Both products carry a CE mark which indicates marketability in the European Economic Area (EEA). For additional information see the BioSURE® website and the autotest VIH® website. Although HIV self-testing has been legalized in several European countries, as well as Australia, no other products are currently licensed for self-testing in these settings. 

Diagnostics in development for HIV self-testing

Other HIV rapid diagnostic tests that use whole-blood (fingerstick) or oral fluid (mouth swab) could be used for self-testing. Other HIV RDTs for HIVST are available, but many have yet to be rigorously evaluated for self-testing. At this time there is one target product profile, that may be useful for determining ideal components and features for a HIV self-test kit.

At this time, generally, available HIV rapid diagnostic tests that could be used for HIVST provide results in less than 30 minutes and usually have a 6 -12 week window period, the time between suspected HIV infection and the time when the assay can detect HIV antibodies. However, the length of the window period may be affected by a number of factors.

Currently no HIV RDTs have been pre-qualified by the World Health Organization (WHO) for HIVST. For the list of WHO prequalified rapid diagnostic tests please see this link. Also the list of tests that are currently in the process of being pre-qualified are available here