FDA Approves Only One HIV Home Test Kit
February 4, 2008
The Food and Drug Administration recently issued a reminder to consumers that there is only one FDA-approved home testing kit for HIV. Numerous unapproved HIV tests are being marketed, the agency said, promising results in the home in 15 minutes or less. Some makers even claim FDA approval or that their facilities are agency-licensed. The only approved test is marketed as "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System." These require users to collect a blood specimen that is sent to a laboratory for analysis. No FDA-approved HIV test kit allows results to be interpreted at home, regulators said. For more information, visit www.fda.gov/consumer/updates/hivtestkit012908.html.
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.