FDA advised to approve at-home HIV test

May 16, 2012 at 9:26 PM
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WASHINGTON, May 16 (UPI) -- An advisory panel of the U.S. Food and Drug Administration recommended approval of the first over-the-counter HIV test, officials said.

The OraSure in-home human immunodeficiency virus test allows a person to use a mouth swab to detect the presence of antibodies to the virus that causes AIDS within about 20 minutes, The Washington Post reported.

Doug Michels, chief executive of OraSure Technologies, said the in-home version is identical to the company's oral rapid swab test widely used by clinics, hospitals and other healthcare providers.

The in-home test has simplified instructions, pictures to help consumers understand how to use the kit and interpret results, and a 24-hour, toll-free telephone number to a customer support center, Michael said.

FDA officials and others have raised concerns about the accuracy of the test -- there can be false negatives -- but members of the advisory panel said identifying new infections and averting HIV transmission to others outweigh the risk of missing some infected people.

Richard Forshee, associate director for research in the FDA Office of Biostatistics and Epidemiology, said the test could potentially identify 45,000 newly infected individuals and avert more than 4,000 HIV transmissions annually in the United States.

Forshee said he estimated the test would miss about 3,800 HIV-positive people per year.

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