ACCESS HBsAg - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Intended purpose

The Access HBsAg assay is intended for the qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum and plasma as an aid in the diagnosis of hepatitis B virus infection and as a screening test for blood and plasma donors. The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and HBsAg Confirmatory assays for the qualitative detection and confirmation of hepatitis B virus surface antigen (HBsAg) in human serum and plasma. The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAg Confirmatory assays. The Access HBsAg Confirmatory assay is intended for the qualitative confirmation of hepatitis B virus surface antigen (HBsAg) in human serum and plasma specimens found to be repeatedly reactive in the Access HBsAg assay as an aid in the diagnosis of hepatitis B virus infection and as a screening test for blood and plasma donors.

Functional description

This one-step enzyme immunoassay is comprised of paramagnetic particles coated with monoclonal HBsAg antibodies, while alkaline phosphatase is coupled to polyclonal HBsAg antibodies with the sample added to a reaction vessel. During incubation, solid phase materials are bound while unbound materials are washed away. A chemiluminescent substrate is added and a luminometer measures the light reaction which is compared to the cut-off value defined during calibration on the instrument.