Alinity i Anti-HBc II Assay - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

TThe Alinity i Anti-HBc II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma, including specimens collected post-mortem (non-heart beating) on the Alinity i analyzer. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heartbeating) that have been collected up to 24 hours after death.

Functional description

The Alinity i Anti-HBc II assay utilizes microparticles coated with recombinant hepatitis B virus core antigen (rHBcAg) for the detection of anti-HBc.