Abbott’s Architect Core
This article was originally published in The Gray Sheet
Firm files PMA for its automated, qualitative hepatitis B diagnostic, which detects antibodies to the hepatitis B virus core antigen. The test is run on the firm's Architect laboratory immunoassay analyzer. Abbott cites CDC statistics indicating that 1.25 million people in the U.S. have chronic hepatitis B
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Firm gains PMA approval for its Architect Core automated hepatitis B test that runs on its Architect i2000 and Architect i2000SR immunoassay testing instruments. Abbott filed the PMA in October (1"The Gray Sheet" Oct. 6, 2008, In Brief). Architect Core is a chemiluminescent microparticle immunoassay for the qualitative detection of the IgG and IgM antibodies to the hepatitis B core antigen in blood serum and plasma. It is indicated for aiding the diagnosis of acute, chronic or resolved hepatitis B virus infection in conjunction with other laboratory results or clinical information. The Centers for Disease Control and Prevention advises individuals needing immunosuppressive therapy to be tested for the hepatitis B core antigen as well as the hepatitis B surface antigen and the antibody to HBsAg, because immunosuppressive therapy may increase the risk for reactivation in patients with resolved hepatitis B infection, according to the company
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