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FDA approves OraQuick for HIV-1 and HIV-2 screenings

FDA approves OraQuick for HIV-1 and HIV-2 screenings

The Food and Drug Administration on Tuesday approved OraSure Technologies' rapid HIV antibody test for simultaneous screening for infection by both HIV-1 and HIV-2 subtypes of the virus. The test had previously been approved only to screen for HIV-1 infection, the strain of the virus most common in the United States. HIV-2 is common in West Africa. The combined screening allows for "broader detection, treatment, and prevention of HIV/AIDS," particularly in urban areas of the United States and in foreign countries, according to a press release from the company. The test can screen blood samples from finger sticks and venipuncture for HIV antibodies and produce results in about 20 minutes. The company is currently seeking FDA approval for the test to screen for HIV-1 and HIV-2 in oral fluids and blood plasma samples

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