New FDA Information on OraQuick In-Home HIV Test

Content From: HIV.govPublished: June 11, 20202 min read


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The U.S. Food and Drug Administration (FDA) has published new information on the OraQuick In-Home HIV Test. This is the only FDA-approved in-home HIV test.

As the information explains, the OraQuick In-Home HIV Test is a rapid self-administered over-the-counter (OTC) test. This approved test uses oral fluid to check for antibodies to HIV Type 1 and HIV Type 2, the viruses that cause AIDS. The OraQuick In-Home HIV Test kit is designed to allow users to take an HIV test anonymously and in private with the collection of an oral fluid sample and find out their result within 20 to 40 minutes in their own home or other private location.

The availability of HIV in-home tests (self-tests) in the US may help increase awareness of HIV infection for people who wouldn’t otherwise get an HIV test. The Centers for Disease Control and Prevention (CDC) encourages health departments to consider HIV self-testing as an additional testing strategy to reach persons most affected by HIV. 

Read the FDA information online or download a PDF version (PDF, 789 KB).

To learn more about HIV self-testing, visit CDC’s Self-Testing.

Note: The Substance Abuse and Mental Health Services Administration (SAMHSA) and the Health Resources and Services Administration Bureau of Primary Health Care (HRSA/BPHC) have recently issued guidance to grantees stating that purchase of in-home test kits is an allowable cost and that self-testing is an appropriate methodology to ensure access to HIV testing.