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FDA approves first oral HIV antibody test. Food and Drug Administration.


 Health care experts say the first recently approved non-blood HIV test, OraSure, is a viable alterative to standard testing and is fast, safe, accurate, and painless. OraSure, developed by Epitope, Inc., and marketed by SmithKline Beecham Consumer Healthcare of Pittsburgh, tests an oral sample called oral mucosal transudate (OMT), rather than saliva. OMT, unlike saliva, contains high concentrations of antibodies and is free from contaminants. The test will be available at physicians' offices, private testing sites, public health departments, and community health services within 3 months. The cost is similar to a blood test. Food and Drug Administration (FDA) approval for the test was based on evidence that showed OraSure to be accurate 99.7 percent when compared to results from blood samples.
