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FDA considers
over-the-counter rapid HIV tests

FDA considers
over-the-counter rapid HIV tests

An advisory panel for the Food and Drug Administration is scheduled to meet on November 3 to consider making the OraQuick rapid HIV antibody test available for over-the-counter purchase and home use, The New York Times reports. The test, called the OraQuick Advance Rapid HIV 1/2 Antibody Test, can produce results in about 20 minutes from oral samples. The tests are currently available only to doctors, HIV clinics, and AIDS service organizations that conduct street-level testing programs, but the FDA panel is expected to recommend that they be available directly to consumers.

The test is simple to use, says developer OraSure Technologies. Users swab their gums and place the swab in a holder. After 20 minutes, one line will appear on the holder if the test is negative for HIV infection, and two lines if the test result is positive. Its ease of use makes it ideal for home use by adults who may be too nervous to seek testing from their doctors or an HIV clinic or are afraid of the stigma associated with possibly receiving positive test results at a public testing facility, proponents say. At-home testing also could help identify the estimated one third of Americans who are HIV-positive but unaware they're infected.

But many AIDS advocates and health officials say at-home testing could be dangerous because there is no counseling component involved, and those who test positive may panic and possibly attempt suicide with no one there to talk with them about their results and their options for treatment and support.

OraSure president Douglas Michels says the company would include any FDA-recommended advice about counseling on the product's label--including referrals to a 24-hour counseling center, a hotline number, Internet support, and printed material--if it were approved for over-the-counter sales. (

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