Atellica IM aHBcM - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

In vitro diagnostic use in the qualitative determination of IgM response to the core antigen of the hepatitis B virus (HBc IgM) in human serum and plasma. This assay is used in combination with other hepatitis B virus (HBV) marker assays in individuals (children, adolescents, and adults) to define the clinical status of known HBV infected patients or it can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis.

Functional description

The Atellica IM aHBcM assay is an IgM‑capture immunoassay using a 2‑step format. Antibody-antigen complexes will form if anti‑HBc IgM is present in the sample.