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FDA Approves OraQuick Rapid Test for HIV-1, HIV-2 Antibodies
OraSure Technologies on Tuesday announced that FDA has approved its rapid blood test that can detect both HIV-1 and HIV-2 antibodies, Reuters reports (Reuters, 3/23). The OraQuick Rapid HIV-1/2 test simultaneously detects antibodies to HIV-1 and HIV-2 through finger-stick and venipuncture blood samples. The test previously had been approved only for use in detecting HIV-1 (Wall Street Journal, 3/24). The new combined HIV-1 and HIV-2 test will allow for "broader detection, treatment and prevention of HIV/AIDS," according to an OraSure release. The combined testing is "particularly important in the higher prevalence urban areas ... in the United States where HIV-2 infection is more likely to occur and in many foreign countries where HIV-2 testing is required as part of the normal testing regimen," OraSure President and CEO Mike Gausling said. The number of documented HIV-2 cases in the United States is relatively low, compared with the number of cases in other countries, according to the release (OraSure release, 3/23). The company also is seeking FDA approval of OraQuick Rapid HIV-1/2 tests using oral fluids and blood plasma samples, the Wall Street Journal reports (Wall Street Journal, 3/24).
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