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Abbott HIV Test Demonstrates Earlier Disease Detection
Date:7/22/2009

CHICAGO, July 22 /PRNewswire-FirstCall/ -- Research presented today at the American Association for Clinical Chemistry annual meeting shows that an assay developed by Abbott for simultaneous detection of both HIV antigens and antibodies reduced the detection window by zero to nine days in this study compared to HIV antibody-only assays. Earlier detection was shown on four of the five panels tested.

"The ability to use a blood test to diagnose HIV sooner, in the acute phase of the disease where antibodies are not yet present, presents an exciting opportunity in the fight against HIV," said Gerald Schochetman, Ph.D., senior director, infectious diseases, research and development, Abbott Diagnostics. "This data is very promising and we are excited about the clinical potential of this assay to help detect HIV earlier."

The Abbott ARCHITECT HIV Combo (Ag/Ab) assay is an automated immunoassay test designed to detect HIV p24 antigen and antibodies to HIV type 1 (HIV-1 Group M and Group O) and/or type 2 (HIV-2) in human serum and plasma. Unlike conventional HIV serology assays that only detect HIV antibodies, ARCHITECT HIV Combo (Ag/Ab) incorporates HIV p24 antigen detection which enables laboratories to diagnose HIV infection before HIV antibodies are detectable. HIV p24 antigen is a viral protein of the HIV antigen.

The assay was launched in Europe in 2004 and is not yet available in the United States. Abbott expects to submit a pre-market approval application for the ARCHITECT HIV Combo (Ag/Ab) assay to the U.S. Food and Drug Administration (FDA) later this year. Upon approval, Abbott's new ARCHITECT HIV Combo assay will continue Abbott's long history of leadership in HIV diagnostics. Abbott developed the first-ever test for HIV almost 25 years ago, in 1985.

About HIV

The Centers for Disease Control and Prevention (CDC) estimates that
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