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First rapid, at-home HIV test gets FDA approval

Federal health officials have approved the first at-home test to detect HIV antibodies, a move aimed at identifying and treating the estimated 20 percent of infected people in the U.S. who don’t know they have the virus that causes AIDS.

Food and Drug Administration officials on Tuesday approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered test that rapidly detects possible HIV infection. Despite concerns about learning of the serious diagnosis at home, an FDA panel unanimously agreed that the benefits of the home test outweigh the risks.

"It's extremely exciting," said Carl Schmid, deputy executive director of the AIDS Institute, a nonprofit that focuses on issues surrounding the disease. "It could be a potential game-changer for HIV."

Manufactured by OraSure Technologies Inc. of Bethlehem, Pa., the test uses swabs of oral fluids from the upper and lower gums, which are then tested for presence of antibodies to the human immunodeficiency virus type 1, HIV-1, and type 2, HIV-2.

Test results are available within 20 to 40 minutes.

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