Performance of hepatitis B surface antigen tests with the first WHO international hepatitis B virus genotype reference panel

• Published in: Journal of clinical virology 2013-09, Vol.58 (1), p.47-53
• Main Authors: Chudy, M, Scheiblauer, H, Hanschmann, K.-M, Kress, J, Nick, S, Wend, U, Schüttler, C, Nübling, C.M, Gerlich, W.H
• Format: Article
• Language: English
• Subjects: Allergy and Immunology; Clinical Laboratory Techniques - methods; Clinical Laboratory Techniques - standards; Genotype; HBsAg; HBsAg unitages; HBV diagnostics; HBV genotype diversity; HBV genotype sensitivity; Hepatitis B - diagnosis; Hepatitis B - virology; Hepatitis B Surface Antigens - genetics; Hepatitis B virus - classification; Hepatitis B virus - genetics; Humans; Infectious Disease; Laboratory Proficiency Testing; Reference preparations; Sensitivity and Specificity; World Health Organization
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2013.06.011

Abstract Background Standardization of hepatitis B surface antigen (HBsAg) tests is indispensable for consistent quality and comparability. Ideally, the assays should detect all known hepatitis B virus (HBV) genotypes equally well. Objective Development of an HBV genotype reference panel for HBsAg assays representing the most prevalent HBV subgenotypes to address commutability and traceability of the heat-inactivated 2nd WHO International Standard (IS) for HBsAg in relation to native HBsAg and to HBV genotypes. Study design An HBV panel of 15 non-inactivated lyophilized specimens representing the subgenotypes A1, A2, B1, B2, C2, D1-D3, E, F2, and H was evaluated in parallel to the IS by 15 laboratories using 19 different HBsAg tests and tree unitages. The virus content of the samples was reduced by ultracentrifugation and dilution to