The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult 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)] using the DxI 9000 Access Immunoassay Analyzer.The Access HBsAg assay is used for the laboratory diagnosis of acute or chronic hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, when used in conjunction with other serological and clinical information. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen, using a chemiluminescent immunoassay method.