ADVIA Centaur HBsAg Confirmatory (Conf) - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Intended purpose

An in vitro diagnostic immunoassay for 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, children, adolescents, and adults) to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur HBsAgII (HBsII) assay. Specimens may be obtained while the donor’s heart is still beating.

Functional description

The ADVIA Centaur Conf assay uses the principle of specific antibody neutralization to confirm the presence of HBsAg in a sample that is repeatedly reactive for HBsAg.