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.
The Centers for Disease Control and Prevention (CDC) estimates that there are more than 35,000 new cases of HIV reported in the United States annually. In 2008, UNAIDS estimated that 2.7 million people throughout the world are newly infected with HIV each year. Leading risk factors for HIV infection include male-to-male sexual contact, high-risk heterosexual contact and intravenous drug use.
ARCHITECT HIV Combo (Ag/Ab) assay is not intended for use in blood screening, plasma or tissue donors. The effectiveness of ARCHITECT HIV Combo (Ag/Ab) for use in screening blood, plasma or tissue donors has not been established. The assay result does not distinguish between the detection of HIV p24 antigen, HIV-antibody, or HIV-2 antibody.
About Abbott's Diagnostics Businesses
Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs. The history of Abbott is filled with examples of first-of-a-kind diagnostic products and significant technological and research advancements.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
ARCHITECT is a trademark of Abbott Laboratories.
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