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FDA panel calls
for clinical trials of possible at-home rapid HIV test

FDA panel calls
for clinical trials of possible at-home rapid HIV test

Tests would gauge whether consumers could properly administer the rapid oral HIV test.

The Food and Drug Administration's Blood Products Advisory Committee, considering a request by OraSure Technologies to market its rapid HIV antibody test to consumers for at-home use, has ruled that the company must launch a clinical trial to gauge its safety and accuracy when used in nonclinical settings. The test should determine whether people could perform the test correctly at home and what the psychological risks would be for those who received a positive result, the panel said.

OraSure officials say the test is easy to use; an oral swab is rubbed on the gums and then placed in a holder. After 20 minutes, one line appears on the test strip if the results are negative; two lines appear if the test is positive. Because of its ease of use, the OraQuick rapid HIV test already has been approved for use by nonmedical personnel, including outreach workers conducting street-level HIV testing programs.

OraSure CEO Douglas Michels says the company will have clinical trial plans in place by the end of the month and hopes to launch the study by this summer. (The Advocate)

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