Atellica IM Hepatitis B surface Antigen II (HBsII) - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Intended purpose

In vitro diagnostic use in the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA, lithium heparin and sodium heparin). The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. The assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. The assay may be used for screening donors whose blood or blood products are intended for transfusion or for further manufacture, or to screen donors whose cells, tissues, and organs are intended for transplant. 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 assay is a sandwich immunoassay using direct chemiluminometric technology.