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

Intended purpose

The Alinity i HBsAg Qualitative II 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) on the Alinity i 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

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.