Assay Detects IgM Antibodies to Hepatitis Core Antigen Virus

The qualitative test aids in the laboratory diagnosis of acute or recent virus infection.

Called Architect Core-M, the test completes a panel of four tests for acute viral hepatitis on the Architect system. Other Architect hepatitis assays available include a test used to monitor immune response to the hepatitis B vaccine and susceptibility to the hepatitis B virus, and a test for confirming the presence of hepatitis B surface antigen.

Architect Core-M is a chemiluminescent microparticle immunoassay for the qualitative detection of IgM antibody to HBV core antigen in human adult and pediatric serum or plasma and neonatal serum. This assay is intended for use as an aid in the diagnosis of individuals with acute or recent hepatitis B viral infection in conjunction with other laboratory results and clinical information, and is not intended for use in screening blood, plasma, or tissue donors. The assay is intended for in-vitro diagnostic use.

The new Architect Core-M hepatitis B assay was developed by of Abbott (Abbott Park, IL, USA), a broad-based health care company, and has received approval from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA).


Related Links:
Abbott
U.S. Food and Drug Administration