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FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
Date:6/21/2010

ABBOTT PARK, Ill., June 21 /PRNewswire-FirstCall/ -- Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

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 percent of HIV infections in some high- risk populations because they do not detect antigens. However, Abbott's new as
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