At-Home HIV Test Moves Step Closer to Reality

FDA panel gives OraQuick thumbs up; final decision expected later this year
By Evann Gastaldo,  Newser Staff
Posted May 16, 2012 7:02 AM CDT
At-Home HIV Test Moves Step Closer to Reality
The OraQuick(R) Rapid HCV Antibody Test by OraSure Technologies -- the first and only oral fluid rapid HCV test bearing a CE Mark.   (GLOBE NEWSWIRE)

About 240,000 HIV carriers in the US are unaware of their infection—and they may soon have a quick and easy way to test for the virus at home. The over-the-counter OraQuick test requires a mouth swab and delivers results in 20 minutes, and though it is likely slightly less accurate than a professionally-administered test, the FDA's advisory panel has determined that the benefits of expanding testing outweigh any risks. The panel’s 17 members voted unanimously in favor of the test yesterday, and the FDA will make a final decision later this year.

While the test, made by Orasure, is accurate 99% of the time when administered by professionals (it's been available to them since 2004), a trial found it only correctly identified the virus in 93% of cases when administered at home. At that rate, it would miss an estimated 3,800 cases per year, but it would correctly identify about 45,000 cases and could thus prevent around 4,000 new transmissions each year, depending on how many people use it. New infections have numbered around 50,000 for the past 20 years, the AP reports. Just last week, another FDA panel endorsed the first pill to prevent HIV. (More HIV stories.)

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