FDA Sanctions Abbott’s Test that Detects HIV Antigen and Antibodies

Assay identifies HIV p24 antigen and antibodies to HIV-1 group M and group O and/or HIV-2.

FDA has approved Abbott’s Architect HIV Ag/Ab Combo assay for the simultaneous detection of both HIV antigen and antibodies. The firm says studies have demonstrated that the test may detect HIV days earlier than antibody-only diagnostics. The test is already sanctioned for use outside the U.S.

CDC research found that current antibody-only tests miss up to 10% of HIV infections in some high-risk populations because they do not detect antigens, according to Abbott. The Architect HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay that detects HIV p24 antigen and antibodies to HIV-1 group M and group O and/or HIV-2 in human adult and pediatric serum and plasma.

The Architect HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. It may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pregnant women. An Architect HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody. The performance of this assay has not been established for individuals younger than two years of age.

“Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life saving,” notes Peter Leone, M.D., medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill. “A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate.”