Abbott announced today it has submitted a Premarket Approval application to the U.S. FDA for the ARCHITECT HIV Ag/Ab Combo test.
The test can aid in the early detection of HIV and is under expedited review by the FDA. HIV combination tests are able to detect the combined presence of both HIV antigens (proteins produced by the HIV virus) and antibodies (proteins produced by the body to fight HIV antigens).
Studies show antibody-only tests fail to identify up to 10% of HIV infections in high-incidence populations. A combined antibody and antigen test holds considerable promise for HIV screening and could assist in detecting infections before antibodies can be identified. Upon approval, this test would be the first of its kind available in the US.
The US submission comes as Abbott marks the 25th year since the company developed the first FDA approved test for HIV.