Device Dossier
ARCHITECT Anti-HBc II assay (8L44) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Device Dossier for ARCHITECT Anti-HBc II assay (8L44) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis B virus…
Intended purpose
The ARCHITECT Anti-HBc II assay is a chemiluminescent microparticle immunoassay (CMIA) 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 ARCHITECT analyser. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.
Functional description
A chemiluminescent microparticle assay for the qualitative determination of anti-HBc in clinical specimens.