Abbott has received premarket approval (PMA) from the US Food & Drug Administration (FDA) for Architect CORE, an automated hepatitis B test for use on its ARCHITECT i 2000 and i 2000SR immunoassay testing instruments.
ARCHITECT CORE is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) in human adult and paediatric serum and plasma and neonatal serum. It is intended as an aid in diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.
ARCHITECT CORE will build upon the current ARCHITECT menu of hepatitis A, hepatitis B and hepatitis C diagnostic tests. ARCHITECT i 2000 and i 2000SR currently offer HAVAB-M, HBsAg / HBsAg Confirmatory, CORE-M, AUSAB and Anti-HCV. The ARCHITECT i 2000SR is designed to be seamlessly integrated with the ARCHITECT c8000 clinical chemistry analyzer. The benefit of integration is that laboratories have the ability to perform common hepatitis tests and associated liver enzyme panels from one patient sample.
The Centers for Disease Control and Prevention currently recommends that individuals needing immunosuppressive therapy be tested for hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) because immunosuppressive therapy may increase the risk for reactivation in persons with resolved hepatitis B infection. Individuals found to be positive for anti-HBc should be monitored closely for signs of liver disease. With this announcement, the ARCHITECT now offers all three recommended tests.
"This approval provides an important test with excellent clinical performance for our laboratory customers and the patients they serve," said Mike Warmuth, senior vice president, diagnostics, Abbott.
In addition to the ARCHITECT, Abbott also offers a comprehensive line of automated hepatitis tests for use on its AxSYM instrument, including, AxSYM HAVAB 2.0, AxSYM HAVAB-M 2.0, AxSYM HBsAg/HBsAg Confirmatory, AxSYM AUSAB, AxSYM CORE 2.0, AxSYM CORE-M 2.0 and AxSYM anti-HCV.
Abbott's AxSYM and ARCHITECT assays listed are restricted to sale and distribution by or on the order of a physician, or to a clinical laboratory, and use is restricted to, by or on the order of a physician.