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US regulators set to approve HIV home-testing kit
Roger Pebody, 2012-05-16 15:50:00
HIV home testing is soon likely to become legal in the United States, following a unanimous vote in support of the OraQuick In-Home HIV Test by a panel of experts advising the Food and Drug Administration (FDA).
The test that may be made available over-the-counter is designed to be used at home, without medical supervision. A sample is taken by swabbing an absorbent pad around the outer gums, adjacent to the teeth; the results are given in twenty minutes.
The 17 members of the Blood Products Advisory Committee (BPAC) voted unanimously that the benefits of the test outweigh its potential risks for consumers. While the test is not as accurate as professionally-administered tests, the panel felt it could provide an important way to make HIV testing available to more people.
The FDA is not bound to follow the recommendations of its advisory committees, but usually does so. This would be the first complete home-based screening test for any infectious disease available for purchase from US pharmacies and internet retailers.
The panel heard overwhelmingly supportive public testimony from more than two dozen witnesses including HIV activists, black community representatives and public health experts.
Source:1
