Architect CORE is a chemiluminescent microparticle immunoassay (CMIA) used to detect IgG and IgM antibodies to hepatitis B core antigen (anti-HBc).
The company includes hepatitis B test to its wide-ranging menu of Immunoassays on the ARCHITECT i 2000 and i 2000SR.
Mike Warmuth, Senior Vice President, Diagnostics, Abbott, said: “This approval provides an important test with excellent clinical performance for our laboratory customers and the patients they serve.”
Architect CORE will build on the company’s current viral hepatitis testing menu which comprises assays for the detection of acute viral hepatitis (HAVAB-M, HBsAg, CORE-M and Anti-HCV). The acute viral hepatitis panel facilitates to identify and diagnose patients infected with hepatitis A, hepatitis B and/or hepatitis C.
