Immunoassay Detects Antibodies to Hepatitis B Core Antigen

A chemiluminescent, microparticle immunoassay (CMIA) detects immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis B core antigen (anti-HBc) in human adult and pediatric serum and plasma and in neonatal serum.

The automated immunoassay, which is called Architect Core, will aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.

Abbott (Abbott Park, IL, USA) announced that Architect Core has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) for the automated hepatitis B test for use on its Architect i 2000 and i 2000SR immunoassay testing instruments.

Architect Core is an addition to 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 was designed to be seamlessly integrated with the Architect c8000 clinical chemistry analyzer. This enables laboratories to perform common hepatitis tests and associated liver enzyme panels from one patient sample.

The U.S. Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) 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. Architect offers all three recommended tests.

Architect assays are not intended for use in screening blood, plasma, or tissue donors.

Abbott offers a broad range of instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices, and clinics.

Related Links:
Abbott
U.S. Food and Drug Administration
U.S. Centers for Disease Control and Prevention