At-Home HIV Test Backed by FDA Panel

US Pharm. 2012;37(6):1.

Rockville, MD—An FDA advisory panel has recommended approval of the first HIV test that can be administered in the privacy of one’s own home. OraQuick detects the presence of HIV, the virus that causes AIDS, in oral fluid within 20 minutes. The test, which is manufactured by OraSure Technologies, is already used by medical professionals at hospitals and physician offices. Its overall accuracy is similar to that of a blood test, although it is slightly less accurate. Experts have expressed concern about the lack of counselor support for newly identified HIV-positive individuals taking the at-home test. The FDA usually follows the recommendations of its advisory panels. [Editor’s Note: OraQuick received FDA approval on 7/5/12.]

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