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FDA Panel to Consider At-Home HIV Test
Date:5/15/2012

By Randy Dotinga
HealthDay Reporter

TUESDAY, May 15 (HealthDay News) -- Should Americans be able to buy a test at the drugstore and use it to determine whether they're infected with the virus that causes AIDS?

A U.S. Food and Drug Administration advisory panel plans to debate this question Tuesday, and the answer the panel arrives at could pave the way toward a new era in HIV testing.

FDA advisory panel recommendations are not binding, but they are often followed by the agency.

"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 test, known as OraQuick, patients 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 are considered preliminary, and should be confirmed by a blood test.

At its meeting this week, the panel is expected to discuss the fact that the test is not as accurate as HIV blood tests.

OraSure, the company that manufactures OraQuick, had nearly 5,700 people take the at-home version of the test. The tests found that 114 thought they were HIV-positive; 106 of them actually were. That means that positive results were accurate 93 percent of the time. Negative results were accurate 99.98 percent of the time, the company said.

Pant Pai said t
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