Reuters: Regulatory News: FDA approves OraSure in-home HIV test

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FDA approves OraSure in-home HIV test Jul 3rd 2012, 16:36 July 3 | Tue Jul 3, 2012 12:36pm EDT July 3 (Reuters) - U.S. health regulators on Tuesday said it has approved OraSure Technologies Inc's in-home test for HIV, making it the first available over-the-counter, self-administered test for the virus that causes AIDS. The Food and Drug Administration gave its green light to the OraQuick In-Home HIV Test, which can provide results of an oral fluid sample taken by swabbing the upper and lower gums inside the mouth, within 20 to 40 minutes. The agency cautioned that a positive result does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test.

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