Abbott announced that the FDA has approved its ARCHITECT HIV Ag/Ab Combo assay that detects both HIV antigens and antibodies. The ARCHITECT HIV Ag/Ab Combo is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in serum and plasma. Because the HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection, the ARCHITECT HIV Ag/Ab Combo assay may detect HIV infection days earlier than antibody-only tests.

The ARCHITECT HIV Ag/Ab Combo is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection.  This assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in children ≥2 years of age and in pregnant women.

For more information call (609) 454-9000 or visit www.abbott.com.