Take-Home HIV Test Approved by FDA in Unanimous Vote Could Prevent Thousands of Transmissions, Annually

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If you have sex, you should get tested for HIV, the virus that causes AIDS, on the regular. In reality, not enough of us do—or at least not as frequently as we should. That all might change, now, thanks to an over-the-counter take-home HIV test that was approved by the 17 members of the FDA in an unanimous vote today.

The OraQuick HIV test is really nothing more than a simple mouth swab—just like the one taken by bone marrow donors—with results returned in as little as 20 minutes. While it is not as reliable as professionally-administered diagnostics, the FDA is hopeful that OraQuick will set a new trend in expanding HIV testing and prevention.

Based in Bethlehem, Pa., Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

But a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved for U.S. consumers. The test could prevent 4,000 new transmissions of the virus annually, though the figure could vary depending on how many people purchase the test.


Despite its imperfect performance, the test is seen as a step in the right direction toward preventing transmission, because anything that inspires more people to test themselves is irrefutably helpful to the cause. In a recent survey of gay and bisexual men, it was reported that the ability to purchase a take-home test over the counter would motivate 84% of them to test themselves more frequently.

As the New York Times reports, the final decision on whether the OraQuick HIV test will be approved for commercial use awaits a final vote later this year. [NYT - Image via PeJo/Shutterstock]