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OTC HIV Rapid Tests: Issue SummaryOTC HIV Rapid Tests: Issue SummaryBelow is contextual information regarding the design of proposed studies to support marketing approvalof Over-the-Counter (OTC) home-use HIV test kits which includes an historical overview of rapid HIVtest kit approval in the United States, and key issues for consideration by the FDA Blood ProductsAdvisory Committee. Once posted, transcripts of the March 10, 2006 advisory committee meeting willbe available on the FDA website at http://www.fda.gov/ohrms/dockets/ac/cber06.html#BloodProductsIssueFDA seeks the advice of the Committee on proposed studies that would be needed to validate a homeuse HIV test kit with regard to test accuracy, test interpretation, and medical follow-up based on theprovision of informational material in place of a trained test operator and counselor.BackgroundRapid HIV Tests:Over the past four years, FDA has approved a number of rapid HIV tests of low complexity, whichare simple to use, require no special storage conditions and provide a highly accurate test resultwithin 20 minutes for the detection of antibodies to HIV. Two of these tests were found to besimple enough to perform that they received a CLIA waiver, expanding the availability of testing.FDA has required, as a condition of approval, that the lower 95% confidence bound for estimatedtest sensitivity and specificity should be 98% or greater.Whereas most HIV tests require the use of a blood specime

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