It takes between 20 and 40 minutes for the OraQuick In-Home HIV Test to deliver results on whether a person is HIV positive, but it took seven years for the test to win Food and Drug Administration approval for over-the-counter sales to patients.
FDA officials required the product’s manufacturer, OraSure Technologies, to conduct studies to prove that patients could reliably follow written instructions to use the test, interpret the results and access follow-up care. In July, OraSure won FDA approval.
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