Which HIV test is FDA approved?

Updated: Mar 05, 2020
  • Author: Shelley A Gilroy, MD, FACP, FIDSA; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

In August 2013, the FDA approved Alere Determine HIV-1/2 Ag/Ab Combo test (Orgenics, Ltd) as the first rapid 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. [8, 9] The test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors. [8, 9]


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