Multi-centre evaluation of a new hepatitis B surface antigen (HBsAg) assay on the family of Access® immunoassay systems
Abstract number: 1733_672
Pivert A., Ducancelle A., Levayer T., Descamps F., Maniez-Montreuil M., Artus A., Heinen C., Woodrum D., Lunel-Fabiani F.
Background: Accurate detection of Hepatitis B Surface Antigen (HBsAg) is an important goal for the diagnosis of patients infected with the hepatitis B virus (HBV). A multi-centre study was conducted to characterise the clinical performance of the new HbsAg assay on the family of Access immunoassay systems from Beckman Coulter currently in development. The Access HBsAg and HBsAg Confirmatory assays are based on paramagnetic particle, solid phase technology and chemiluminescent signal detection.
Methods: Percent negative agreement (relative specificity) was calculated from 5,020 prospectively enrolled blood donors from two blood donation centres and 566 subjects from a university hospital for whom the HBsAg assay was requested by their physician as a part of their routine medical evaluation (due to suspected exposure or increased risk of HBV, signs and symptoms of infection, or prenatal screening of pregnant women). Percent positive agreement (relative sensitivity) was calculated from 290 subjects with a diagnosis of acute or chronic HBV infection who were prospectively enrolled or whose samples had been archived in a sample repository. Percent negative and positive agreements were calculated relative to the Abbott PRISM® and Abbott AxSYM® immunoassay systems.
Results: Negative percent agreement for the Access HBsAg assay in a blood donor population was 99.96% (5,018/5,020) [95% CI: 99.86100%]. Negative percent agreement for the Access HBsAg assay at the university hospital was 99.65% (564/566) [95% CI: 98.7399.96%]. Discrepant samples were not confirmed in the Access HBsAg Confirmatory assay and agreement between methods after confirmatory testing was 100%. Positive percent agreement for subjects with known HBV infection in the Access HBsAg assay was 100% (290/290) [95% CI: 98.69100%]. All positive samples were confirmed in the Access HBsAg Confirmatory assay. Excellent separation of positive and negative populations was observed.
Conclusion: The Access HBsAg and the Access HBsAg Confirmatory assays provide excellent sensitivity and specificity for the detection of HBsAg in hospital and blood donor populations with the advantage of a rapid, automated, random-access immunoassay system.
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|Session name:||European Society of Clinical Microbiology and Infectious Diseases|
|Location:||ICC, Munich, Germany|
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