First Rapid HIV Test of Oral Fluid

The test has been cleared by the U.S. Food and Drug Administration (FDA) for oral fluid and also approved for use on plasma samples.

The approval was announced by officials representing the government, the FDA, and the Centers for Disease Control and Prevention at a press conference in Washington (DC, USA). Called OraQuick HIV-1/2, the test was developed by OraSure Technologies, Inc. (Bethlehem, PA, USA), and has been approved for detecting antibodies to HIV in oral fluid and antibodies to both HIV-1 and HIV-2 in plasma samples. OraSure is seeking a license to certain relevant patents held by Bio-Rad Laboratories (Hercules, CA, USA), and is optimistic that a license will be obtained in the near future.

"Countries battling the war against AIDS should have complete access to the same technology that we use on ourselves and our families here in America,” said George W. Haley, former U.S. ambassador to the Republic of Gambia. "Because of its design, OraQuick can be used virtually anywhere, at anytime, and by anyone, with minimal cost, training, and safety issues. Now is the time to scale up rapid testing, and this simple test is one of the answers.”




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