Performance evaluation of 70 hepatitis B virus (HBV) surface antigen (HBsAg) assays from around the world by a geographically diverse panel with an array of HBV genotypes and HBsAg subtypes

Background and Objectives  This study was conducted by the International Consortium for Blood Safety (ICBS) to identify high‐quality test kits for detection of hepatitis B virus (HBV) surface antigen (HBsAg) for the benefit of developing countries.

[1]  S. Nick,et al.  Sensitivities of CE‐marked HIV, HCV, and HBsAg assays , 2007 .

[2]  W. Jilg,et al.  High genetic variability of the group-specific a-determinant of hepatitis B virus surface antigen (HBsAg) and the corresponding fragment of the viral polymerase in chronic virus carriers lacking detectable HBsAg in serum. , 2000, The Journal of general virology.

[3]  Helen H. Lee,et al.  Evaluation of a New Hepatitis B Virus Surface Antigen Rapid Test with Improved Sensitivity , 2008, Journal of Clinical Microbiology.

[4]  M. Purdy,et al.  A New Algorithm for Deduction of Hepatitis B Surface Antigen Subtype Determinants from the Amino Acid Sequence , 2006, Intervirology.

[5]  W. Gerlich,et al.  Standardized detection of hepatitis B surface antigen: determination of its serum concentration in weight units per volume. , 1975, Developments in biological standardization.

[6]  L. Mimms,et al.  The prevalence of surface antigen variants of hepatitis B virus in Papua New Guinea, South Africa, and Sardinia , 1997, Hepatology.

[7]  S. Schaefer,et al.  Hepatitis B virus genotypes: comparison of genotyping methods , 2004, Reviews in medical virology.

[8]  R F Schinazi,et al.  A new genotype of hepatitis B virus: complete genome and phylogenetic relatedness. , 2000, The Journal of general virology.

[9]  K. Yamaguchi,et al.  Reactivity of genotypically distinct hepatitis B virus surface antigens in 10 commercial diagnostic kits available in Japan. , 2005, Japanese journal of infectious diseases.

[10]  H. Sakugawa,et al.  Typing hepatitis B virus by homology in nucleotide sequence: comparison of surface antigen subtypes. , 1988, The Journal of general virology.

[11]  A. Couroucé,et al.  Complete genomes, phylogenetic relatedness, and structural proteins of six strains of the hepatitis B virus, four of which represent two new genotypes. , 1994, Virology.

[12]  I. Mushahwar,et al.  Immunoassay detection of hepatitis B surface antigen mutants , 1999, Journal of medical virology.

[13]  Y. Cossart,et al.  Cellular immune response of ducks to duck hepatitis B virus infection , 1999, Journal of medical virology.

[14]  B. Robertson,et al.  Genotype H: a new Amerindian genotype of hepatitis B virus revealed in Central America. , 2002, The Journal of general virology.

[15]  K. Tadokoro,et al.  Lengths of hepatitis B viremia and antigenemia in blood donors: preliminary evidence of occult (hepatitis B surface antigen–negative) infection in the acute stage , 2007, Transfusion.

[16]  L. Stuyver,et al.  Hepatitis B virus genotypes and HBsAg subtypes in refugees and injection drug users in the United States determined by LiPA and monoclonal EIA , 2001, Journal of medical virology.

[17]  M. Purdy Hepatitis B virus S gene escape mutants , 2007, Asian journal of transfusion science.

[18]  I. Mushahwar,et al.  Genetic relatedness of hepatitis B viral strains of diverse geographical origin and natural variations in the primary structure of the surface antigen. , 1993, The Journal of general virology.

[19]  A. Osterhaus,et al.  Hepatitis B surface antigen (HBsAg) derived from yeast cells (Hansenula polymorpha) used to establish an influence of antigenic subtype (adw2, adr, ayw3) in measuring the immune response after vaccination. , 2002, Vaccine.

[20]  S. Levicnik-Stezinar Hepatitis B surface antigen escape mutant in a first time blood donor potentially missed by a routine screening assay. , 2004, Clinical laboratory.

[21]  J. Hou,et al.  Epidemiology and Prevention of Hepatitis B Virus Infection , 2005, International journal of medical sciences.

[22]  K. Yamaguchi,et al.  Evaluation of 10 commercial diagnostic kits for in vitro expressed hepatitis B virus (HBV) surface antigens encoded by HBV of genotypes A to H. , 2006, Journal of virological methods.

[23]  D. Lavanchy,et al.  Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures , 2004, Journal of viral hepatitis.

[24]  S. Mishiro,et al.  Hepatitis B virus genomic sequence in the circulation of hepatocellular carcinoma patients: comparative analysis of 40 full-length isolates , 1998, Archives of Virology.

[25]  P. Coursaget,et al.  Genetic Diversity of Hepatitis B Virus Strains Derived Worldwide: Genotypes, Subgenotypes, and HBsAg Subtypes , 2004, Intervirology.

[26]  A. Couroucé,et al.  Molecular basis of hepatitis B virus serotype variations within the four major subtypes. , 1992, The Journal of general virology.

[27]  Yoshinori Iwatani,et al.  Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay. , 2004, Journal of virological methods.

[28]  M. Mizokami,et al.  Classifying Hepatitis B Virus Genotypes , 2003, Intervirology.

[29]  R. Tedder,et al.  A 'first loop' linear epitope accessible on native hepatitis B surface antigen that persists in the face of 'second loop' immune escape. , 2003, The Journal of general virology.

[30]  C. Muller,et al.  Hepatitis B virus genotype E surface antigen detection with different immunoassays and diagnostic impact of mutations in the preS/S gene , 2007, Medical Microbiology and Immunology.

[31]  H. Doerr,et al.  Evaluation of Two New Automated Assays for Hepatitis B Virus Surface Antigen (HBsAg) Detection: IMMULITE HBsAg and IMMULITE 2000 HBsAg , 2003, Journal of Clinical Microbiology.

[32]  A. Zuckerman,et al.  Vaccine-induced escape mutant of hepatitis B virus , 1990, The Lancet.

[33]  S. Nick,et al.  Evaluation of 17 CE‐marked HBsAg assays with respect to clinical sensitivity, analytical sensitivity, and hepatitis B virus mutant detection , 2006, Journal of medical virology.

[34]  F. Sugauchi,et al.  Genotype, serotype, and phylogenetic characterization of the complete genome sequence of hepatitis B virus isolates from Malawian chronic carriers of the virus , 2003, Journal of medical virology.