Alinity s HBsAg Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Intended purpose

The Alinity s HBsAg Confirmatory assay is used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heartbeating), by means of specific antibody neutralization on the Alinity s System. The assay is intended to be used for the confirmation of samples found to be repeatedly reactive by the Alinity s HBsAg assay.

Functional description

This assay is used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma, using automated chemiluminescent microparticle immunoassay (CMIA) technology. This assay consists of two single tests that are both one-step pretreatment immunoassays.