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Home Access on the facts about FDA approval of HIV at-home screen product

Thu, 07/05/2012 - 3:19pm
Bio-Medicine.Org

HOFFMAN ESTATES, Ill., July 5, 2012 /PRNewswire/ -- The Food and Drug Administration (FDA) Tuesday (July 3) approved an over-the-counter screening test for HIV.  The name of the product is the OraQuick In-Home HIV test, manufactured by OraSure Technologies.  The FDA has moved forward despite concerns raised by experts about the accuracy of the product and other issues.

Home Access Health Corporation, based in Hoffman Estates, IL, would like the nation's medical writers to be armed with the facts about this new product and the important distinctions between it and the Home Access Express HIV-1 Test, an over-the-counter HIV test approved by the FDA in 1996.  Home Access does not wish to challenge the FDA's approval of the OraSure product but only to make known the important distinctions between its successful Home Access Express HIV-1 Test and the OraQuick product for purposes of reference and accuracy in news coverage.   For more information, please refer to the FDA website Vital Facts About HIV Home Test Kits.

Key issues and distinctions:

FDA approval:  The Home Access Express HIV-1 Test was approved for over-the-counter sale by the FDA in 1996; FDA approval of OraQuick was approved Tuesday (July 3).

Nature of self-collected test specimen:  Home Access Express HIV-1 uses the more reliable fingerstick blood sample; OraQuick relies on oral fluid.

Speed of confirmed testing results:  Home Access Express HIV-1, confirmed results next business day; OraQuick, 20 minutes for screening results, not confirmed results.  Confirmation of preliminary positive results requires a separate test not available to consumers through OraSure.

Accuracy of results:  In consumer trials, the Home Access® Express HIV-1 demonstrated 100 percent accuracy for both sensitivity and sp
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