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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

say detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.

"Abbott has long been a pioneer in HIV testing -- from the world's first test to detect HIV antibodies in 1985 -- to second and third generation immunoassay and molecular tests – and now the development of the country's first antigen and antibody combination test," said Brian Blaser, senior vice president, Diagnostics, Abbott.  "Abbott is committed to fighting HIV and to bringing novel tests to physicians in order to help patients get the care they need as soon as possible."

This new test will run on Abbott's ARCHITECT family of diagnostic testing instruments. It is already approved for use outside the United States. In Europe, HIV antigen-antibody combination testing is routine in public health settings and HIV testing guidelines in the United Kingdom now direct clinicians to use the HIV combination test as the first-line test.

Important Product Usage and Safety Information

The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human adult and pediatric serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pregnant women. An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection
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