FDA approves first rapid diagnostic test to detect HIV-1 antigen, HIV-1/2 antibodies
August 9, 2013
FDA has 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 (The Alere Determine HIV-1/2 Ag/Ab Combo, Orgenics, Ltd. (an Alere, Inc. company) was approved.