FDA Approves First Rapid Diagnostic Test for Simultaneous Detection of HIV-1 Antigen and Both HIV-1 and HIV-2 Antibodies

“The U.S. Food and Drug Administration today [August 8, 2013] 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. “The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional health care settings. 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. “Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test, can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.” More information is available: FDA: Press release