FDA OKs rapid diagnostic test for HIV-1 antigen, HIV-1/2 antibodies

The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus HIV test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

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