Abbott HBV test
This article was originally published in The Gray Sheet
Executive Summary
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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