Device Dossier

ADVIA Centaur aHBs2 - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for ADVIA Centaur aHBs2 - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis B virus surface total…

Intended purpose

The ADVIA Centaur anti-HBs2 (aHBs2) assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human serum or plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals (neonates, infants, children, adolescents, and adults) prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

Functional description

The ADVIA Centaur anti-HBs2 assay is a sandwich immunoassay using direct, chemiluminometric technology.

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