Access anti-HBs - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The Access anti-HBs assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of antibodies to the hepatitis B virus surface antigen (anti-HBs) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBs assay is used as an aid in the laboratory diagnosis of hepatitis B virus (HBV) infection, when used in conjunction with other serological and clinical information. The Access anti-HBs assay is also intended to be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination, or when vaccination status is unknown. The Access anti-HBs assay is for use on the DxI 9000 Access Immunoassay Analyzer only.

Functional description

Paramagnetic particle, chemiluminescent immunoassay for quantitative determination of antibody levels to hep B surface antigen.