The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitativedetection of total antibodies to hepatitis B virus core antigen (anti-HBc) in human pediatric (2 through 21 years) and adultserum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA,tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD) and citrate phosphate dextrose (CPD)] using theDxI 9000 Access Immunoassay Analyzer.The Access anti-HBc Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitisB virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, includingpregnant women, when used in conjunction with other laboratory results and clinical information.The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.This assay is not intended for the screening of blood, plasma, and cell or tissue donors.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.