OraSure begins studies for home-use rapid HIV test kit

By E. Janene Geiss

Philadelphia, Sept. 27 - OraSure Technologies, Inc. said Wednesday that it has started several laboratory-based operational studies as the initial stage of the process to obtain Food and Drug Administration approval of the OraQuick Advance test for use in the consumer or over-the-counter market in the United States.

These studies are designed to demonstrate the robustness of the OraQuick test for home use, the Bethlehem, Pa., medical diagnostics company said in a news release.

Specifically, the studies are designed to determine the impact of environmental and common household factors on the performance of OraQuick. Several of these studies recently began and several more are expected to start soon. They are in addition to the studies the company previously performed when it obtained a Clinical Laboratory Improvements Amendments Act of 1988 waiver for the OraQuick test in 2005.

OraQuick Advance is a point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.

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