FDA Approves Abbott’s New HIV Test. 6/10

Current antibody-only tests miss up to 10% of HIV infections in some high-risk populations because they do not detect antigens.

On June 21, Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved “an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.” This marks the fastest approval by the FDA of an automated HIV test to date.

According to the release, “Abbott's ARCHITECT HIV Ag/Ab Combo assay is the first test approved in the United States that 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. Studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.”

“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. “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.”

Studies conducted by the Centers for Disease Control and Prevention (CDC) show that current antibody-only tests miss up to 10% of HIV infections in some high-risk populations because they do not detect antigens. However, Abbott’s new assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.

The Abbott ARCHITECT HIV Ag/Ab Combo assay will be available to consumers in the U.S. later this year.