Atellica IM HBsII Conf - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Intended purpose

In vitro diagnostic use in the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma. The assay is intended to be used in individuals (neonates, infants, children, adolescents, and adults) to confirm the presence of HBsAg in samples that are repeatedly reactive using the Atellica IM Hepatitis B surface Antigen II (HBsII) assay. The assay may be used in samples from pregnant women that are repeatedly reactive using the Atellica IM HBsII assay to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. Specimens may be obtained while the donor's heart is still beating, or from cadaveric (non‑heart‑beating) donors.

Functional description

The Atellica IM HBsII Conf assay uses the principle of specific antibody neutralisation to confirm the presence of HBsAg in a sample that is repeatedly reactive for HBsAg.