US drug panel `backs over-the-counter HIV tests`

Last Updated: Wednesday, May 16, 2012 - 15:26

Washington: Experts have said that a ground -breaking over-the-counter HIV test that can be taken at home is reasonably "safe and effective" for determining whether one has the AIDS virus.

The 17-member US Food and Drug Administration advisory committee voted unanimously for the OraQuick In-Home HIV Test and said that its potential to prevent infections outweighed the risk of false results.

The Food and Drug Administration regulators will decide later this year whether to approve it; it does not have to follow the recommendations of the advisory panel, though it usually does, the `BBC` reported.

The 20-minute test is 93 per cent accurate for positive results and 99.8 per cent for negative, the manufacturer said.

To take the test, the user swabs the outer gum area so the oral fluid, which is not the same as saliva, can be checked for the HIV virus. The test provides results within about 20 minutes, but the experts say the results should be confirmed with a blood test, which is more accurate.

In fact, the experts on the Blood Products Advisory Committee voted 17-0 to back the test, saying it would help people who are HIV-positive get access to healthcare and social services.

The experts urged Pennsylvania-based OraSure, the company that manufactures the product, to include highly visible warnings about false negative results. The panel also advised that the packaging should carry a toll-free phone number offering counselling to those testing positive.

OraSure said the home test could retail for less than US dollars 60 if approved.
Carl Schmid, deputy director of the AIDS Institute, has welcomed the panel`s approval on Tuesday of the home test.

"We are always looking for game changers, and we believe this is one of them. Not only will it help reduce the number of infections but it will bring more people into care and treatment," he was quoted as saying.

PTI



First Published: Wednesday, May 16, 2012 - 15:26

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