Which HIV test is FDA approved?

Updated: Sep 23, 2019
  • Author: Nicholas John Bennett, MBBCh, PhD, MA(Cantab), FAAP; Chief Editor: Michael Stuart Bronze, MD  more...
  • Print
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. [6, 7] 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. [6, 7]


Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!