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

Intended purpose

The Alinity i HBsAg Qualitative II Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the confirmation of the presence of Hepatitis B surface antigen (HBsAg) in human serum and plasma including specimens collected post-mortem (non-heart-beating) up to 24 hours after death, by means of specific antibody neutralization on the Alinity i analyzer. The Alinity i HBsAg Qualitative II Confirmatory assay is intended to be used for the confirmation of samples found to be repeatedly reactive by the Alinity i HBsAg Qualitative II assay.

Functional description

This assay consists of 2 single tests that are both one-step pretreatment immunoassays for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma, using CMIA technology.