Alinity i Anti-HBc IgM Assay - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The Alinity i Anti-HBc IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma on the Alinity i analyzer. The Alinity i Anti-HBc IgM assay is indicated for use as an aid in the diagnosis of acute or recent hepatitis B viral infection.

Functional description

The Alinity i Anti-HBc IgM assay utilizes acridinium-labeled recombinant hepatitis B virus core antigen (rHBcAg) conjugate for the detection of anti-HBc IgM.