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FDA approves OraSure to test hospital blood

FDA approves OraSure to test hospital blood

The Food and Drug Administration on Wednesday gave expanded approval to OraSure Technologies' OraQuick rapid HIV test for use in hospitals to screen blood drawn intravenously for HIV antibodies. The rapid HIV test can produce results in about 20 minutes. The test was previously approved only to test blood obtained from finger pricks, making it an ideal screening method for HIV/AIDS organizations offering HIV testing services. OraSure president of marketing William Bruckner said the expanded approval means that the test can now be used on the roughly 12 million people screened for HIV infection at U.S. hospitals each year. The company is currently completing clinical trials evaluating the effectiveness of OraQuick in detecting HIV antibodies in oral fluids and trials to determine whether the test can detect antibodies in the blood to HIV-2, a less common strain of the virus prevalent in West Africa.

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