FDA Close To Approving Over-The-Counter HIV Test

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A panel of experts just recently recommended approval of the first rapid, over-the-counter HIV test. Now you will be able to test yourself in the privacy of your home.

The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing.

The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel.

Based inBethlehem,Pa., Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

But a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved forU.S.consumers.

Panelists stressed that the test’s labeling should state that a negative reading does not automatically mean the person does not have HIV, because of imperfect results. Panelists also stressed the importance of a toll-free number to put those who test positive in touch with counseling and medical care.

Despite concerns about less-than-perfect use by the public, the panel overwhelmingly sided with more than two dozen HIV advocates and doctors, who said the

The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel.

Via: Huffingtonpost.com

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