Atellica IM aHBs2 - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

In vitro diagnostic use in the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human serum and 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 Atellica IM aHBs2 assay is a sandwich immunoassay using direct chemiluminescent technology