FDA Approves OraQuick for Use in Detecting HIV-2 Antibodies in Oral Fluid

has approved Bethlehem, Pa.-based OraSure Technologies' OraQuick Rapid HIV-1/2 Test for use in detecting HIV-2 antibodies in oral samples, the company announced on Wednesday, Reuters reports (Reuters, 6/23). Although FDA already has approved the test to detect HIV-1 and HIV-2 in blood samples, it had approved the oral version of the test only for HIV-1. The oral test, which produces results in 20 minutes, requires health care workers to wipe a treated swab along the gums of a patient's mouth and place the swab into the testing liquid. If one line appears on the swab, the person is 99.8% likely to be HIV-negative. However, if two lines appear on the swab, the person is 99.3% likely to be HIV-positive, although a laboratory test is required to confirm the result (Kaiser Daily HIV/AIDS Report, 6/23). With the approval, the OraQuick test is the first to be used for rapid, on-site testing of oral fluid, blood collected from a finger stick, venous whole blood and plasma samples for both HIV-1 and HIV-2, according to an OraSure release. The company plans to seek a waiver to sell the drug at more than 180,000 sites in the United States (OraSure release, 6/23).

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