Access anti-HBc Total - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies against the hepatitis B virus core antigen (anti-HBc) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc Total assay is intended to be used as an aid in the diagnosis of hepatitis B virus (HBV) infection,and as a screening test for blood and plasma donors. The assay is not intended for the testing or screening of pooled specimens. The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.

Functional description

The Access anti-HBc Total assay is intended aid in the detection of antibodies to hepatitis B core antigen (anti-HBc Total).