Abbott Labs said the FDA today approved its new diagnostic test that allows for earlier detection of HIV.
Abbott’s ARCHITECTHIV Ag/Ab Combo assay can simultaneously detect both HIV antigen and antibodies. 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. By detecting antigen, Abbott’s new test may detect HIV days earlier than antibody-only tests, the company said.
“Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life saving,” said Peter Leone, M.D., medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill.
This new test will run on Abbott’s ARCHITECT family of diagnostic testing instruments. It is already approved for use outside the United States. In Europe, HIV antigen-antibody combination testing is routine in public health settings and HIV testing guidelines in the United Kingdom now direct clinicians to use the HIV combination test as the first-line test.
