Alinity i HBsAg Next Qualitative Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Intended purpose

The HBsAg Next Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) that have been collected up to 24 hours after death, on the Alinity i system.

Functional description

This assay is a one-step immunoassay for the qualitative detection of HBsAg in human serum and plasma including specimens collected post mortem (non-heart-beating) using chemiluminescent microparticle immunoassay (CMIA) technology.