The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitativedetection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) andadult serum 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)] usingthe DxI 9000 Access Immunoassay Analyzer.The Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis Bvirus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other serologicaland clinical information.The Access anti-HBc IgM 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 immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.