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FDA Panel Backs At-Home HIV Test
Date:5/16/2012

By Randy Dotinga
HealthDay Reporter

TUESDAY, May 15 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Tuesday approval of the first HIV test that would give people the results in the privacy of their own home.

The 17 panel members were unanimous in voting that the benefits of the test were greater than any possible risks. The test kit, known as Oraquick, detects the presence of HIV -- the virus that causes AIDS -- within 20 minutes, the Associated Press reported.

If the FDA heeds the recommendation of its advisory panel, the decision could pave the way toward a new era in HIV testing. The agency typically follows the recommendations of its advisory groups.

OraSure Technologies Inc., which makes the over-the-counter test, already sells a version of it to doctors and other health professionals. Studies have shown the test was less accurate when used by consumers, but the panelists said Tuesday that the benefits of expanding HIV testing outweigh a small drop in test accuracy, according to the AP.

"There is huge global momentum in support of over-the-counter testing for HIV. People desire private, discreet options that protect their confidentiality," said Dr. Nitika Pant Pai, an assistant professor of medicine at Montreal's McGill University who co-authored an analysis of the effectiveness of an at-home HIV test earlier this year.

The test, which looks for signs of HIV in oral fluid, is already used at hospitals and doctors' offices where medical professionals administer it. The FDA first approved its use in 2004.

To take the OraQuick test, people swab their outer gums and put the swab into a vial. After about 20 minutes, the test device will reveal two reddish-purple lines in a small window if there are signs that the body's immune system has geared up to battle HIV.

The test uses oral fluid, which is not the same as saliva. Its results
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