New FDA-approved test first to detect HIV antigen, antibodies

SILVER SPRING, Md. The Food and Drug Administration has approved a new test for detecting HIV antigen and antibodies, the agency said.

The FDA said Abbott’s Architect HIV Ag/Ab Combo assay was the first to detect both antigen and antibodies of HIV and is approved to aid in diagnosis of adults, including pregnant women, with the HIV-1 or HIV-2 strains.

Because it detects the HIV-1 virus in addition to HIV antibodies, it can be used to diagnose HIV infection before antibodies emerge.

“The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun said. “It provides for more sensitive detection of recent HIV infections compared with antibody tests alone.”