Evaluation of 17 CE-marked HBsAg assays with respect to clinical sensitivity, analytical sensitivity, and hepatitis B virus mutant detection

Journal of Medical Virology
Heiner ScheiblauerS Nick

Abstract

Seventeen HBsAg assays, in use in the European market (CE-marked), were assessed for their diagnostic sensitivity using 38 commercially available seroconversion panels, and for their analytical sensitivity with the HBsAg ad and ay standards of the Paul-Ehrlich-Institut (PEI). In addition, the ability to detect HBsAg mutants was investigated by means of 21 recombinant HBsAg mutant samples and 5 natural mutants. Analysis of seroconversion data revealed that there were marked differences in the sensitivity among the CE-marked HBsAg assays. Differences in the window period between the most and the least sensitive assays were up to 2 weeks. Analytical sensitivities of the investigated assays ranged from 0.009 to 0.05 PEI-U/ml for HBsAg ad standard (relating to approximately 0.018 to 0.100 IU/ml of the 2nd WHO HBsAg standard) and 0.012 to 0.11 PEI-U/ml for the ay standard. Clinical and analytical sensitivities were basically correlated. The capacity to detect mutant HBsAg forms was influenced by the assay format and the properties of the monoclonal antibodies used for coating of the solid phase or in the conjugate. While some assays detected all mutants others exhibited weaknesses especially in recognising HBsAg mutations affecting l...Continue Reading

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