Rapid HIV-1 tests
This article was originally published in The Gray Sheet
Executive Summary
CLIA-waived status for the tests is being pursued by an HIV coalition supported by the President's Advisory Council on HIV/AIDS and the Congressional Black Caucus. "We call on [FDA and CMS] to release HIV rapid tests with CLIA waiver immediately," the groups state in an Oct. 24 release, arguing that state regulations provide sufficient safeguards. OraSure received a May "approvable" letter from FDA for its OraQuick rapid HIV test, requiring resolution of "specific validation and control issues" before agency sign-off (1"The Gray Sheet" June 24, 2002, p. 22)...
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