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

Vox Sanguinis

Volumn 98, Issue 3 PART. 2, 2010, Pages 403-414

  Scheiblauer, H ^a   El Nageh, M ^b,c   Diaz, S ^b,c   Nick, S ^c   Zeichhardt, H ^b,c,d   Grunert, H P ^d   Prince, A ^b,c,e  

^a PAUL EHRLICH INSTITUT   (Germany)

^b International Consortium for Blood Safety (ICBS)   (United States)

^c ICBS Europe   (Germany)

^d CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^e Hepatitis Research Foundation   (United States)

Author keywords

HBsAg sensitivity; HBV genotypes; HBV subtypes; ICBS; S gene mutants

Indexed keywords

HEPATITIS B SURFACE ANTIGEN;

AMINO ACID SEQUENCE; ANTIGEN DETECTION; ARTICLE; COMPARATIVE STUDY; DEVELOPING COUNTRY; DIAGNOSTIC ACCURACY; ENZYME IMMUNOASSAY; FALSE NEGATIVE RESULT; GENE MUTATION; GENETIC VARIABILITY; GENOTYPE; HUMAN; LABORATORY TEST; NONHUMAN; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; SEROCONVERSION; VIRUS GENE; VIRUS INFECTION;

AFRICA; AMINO ACID SEQUENCE; ASIA; DEVELOPING COUNTRIES; FALSE NEGATIVE REACTIONS; GENES, VIRAL; GENOTYPE; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HUMANS; IMMUNOENZYME TECHNIQUES; MOLECULAR SEQUENCE DATA; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY; SEQUENCE ALIGNMENT; SEQUENCE HOMOLOGY, AMINO ACID; SOUTH AMERICA; UNITED STATES; WORLD HEALTH;

EID: 77949347538     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2009.01272.x     Document Type: Article

References (40)

1. Hou J, Liu Z, Gu F: Epidemiology and prevention of hepatitis B virus infection. Int J Med Sci 2005; 2:50-58
2. Lavanchy D: Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hep 2004; 2:97-107
3. Nick S, Scheiblauer H: Sensitivities of CE-Marked HIV, HCV, and HBsAg Assays. J Med Virol 2007; 79:S59-S64
4. Scheiblauer H, Soboll H, Nick S: Evaluation of 17 CE-marked HBsAg assays with respect to clinical sensitivity, analytical sensitivity, and hepatitis B virus mutant detection. J Med Virol 2006; 78(S1):S66-S70
5. Carman WF, Van Deursen FJ, Mimms LT, Hardie D, Coppola R, Decker R, Sanders R: The prevalence of surface antigen variants of hepatitis B virus in Papua New Guinea, South Africa, and Sardinia. Hepatology 1997; 26:1658-1666
6. European Union: Commission Decision of 3 February 2009 on common technical specifications for in vitro-diagnostic medical devices 2002/364/ EC. Official Journal of the European Communities 2009; L39/34-L39/49
7. Food and Drug Administration (FDA), U.S. Guidance for Industry: Adequate and appropriate donor screening tests for hepatitis B; hepatitis B surface antigen (HBsAg) assays used to test blood, blood components, including source plasma and source leukocytes. November 2007; http://www.fda.gov/cber/gdlns/ hbslotrel.pdf
8. Carman WF, Zanetti AR, Karayiannis P, Waters J, Manzillo G, Tanzi E, Zuckerman AJ, Thomas HC: Vaccine-induced escape mutant of hepatitis B virus. Lancet 1990; 336:325-329
9. Coleman PF, Chen YCJ, Mushahwar IK: Immunoassay detection of hepatitis B surface antigen mutants. J Med Virol 1999; 58:19-24
10. Weinberger KM, Bauer T, Böhm S, Jilg W: 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. J Gen Virol 2000; 81:1165-1174
11. Purdy MA: Hepatits B virus S gene escape mutants. Asian J Transf Sci 2007; 1:62-70
12. Okamoto H, Tsuda F, Sakugawa H, Sastrosoewignjo RI, Imai M, Miyakawa Y, Mayumi M: Typing hepatitis B virus by homology in nucleotide sequence: comparison of surface antigen subtypes. J Gen Virol 1988; 69:2575-2583
13. Norder H, Courouce AM, Magnius LO: Molecular basis of hepatitis B virus serotype variations within four major subtypes. J Gen Virol 1992; 73:3141-3145
14. Norder H, Hammas B, Lee SD, Bile K, Courouce AM, Mushahwar IK, Magnius LO: Genetic relatedness of hepatitis B viral strains of diverse geographical origin and natural variations in the primary structure of the surface antigen. J Gen Virol 1993; 74:1341-1348
15. Norder H, Courouce AM, Magnius LO: Complete genomes, phylogenetic relatedness, and structural proteins of six strains of the hepatitis B virus, four of which represent two new genotypes. Virol 1994; 198:489-503
16. Sugauchi F, Orito E, Kato H, Suzuki S, Kawakita S, Sakamoto Y, Fukushima K, Akiba T, Yoshihara N, Ueda R, Mizokami M: Genotype, serotype, and phylogenetic characterization of the complete genome sequence of hepatitis B virus isolates from Malawian chronic carriers of the virus. J MedVirol 2003; 69:33-40
17. Miyakawa Y, Mizokami M: Classifying hepatitis B virus genotypes. Intervirology 2003; 46:329-338
18. Norder H, Courouce AM, Coursaget P, Echevarria JM, Lee SD, Mushahwar IK, Robertson BH, Locarnini S, Magnius LO: Genetic diversity of hepatitis B virus strains derived worldwide: genotypes, subgenotypes, and HBsAg subtypes. Intervirology 2004; 47:289-309
19. Purdy MA, Talekar G, Swenson P, Araujo A, Fields H: A new algorithm for deduction of hepatitis B surface antigen subtype determinants from the amino acid sequence. Intervirology 2007; 50:45-51
20. Stuyver L, De Gendt S, Van Geyt C, Zoulim F, Fried M, Schinazi RF, Rossau R: A new genotype of hepatitis B virus: complete genome and phylogenetic relatedness. J Gen Virol 2000; 81:67-74
21. Arauz-Ruiz P, Norder H, Robertson BH, Magnius LO: Genotype H: a new Amerindian genotype of hepatitis B virus revealed in Central America. J Gen Virol 2002; 83:2059-2073
22. World Health Organization (WHO): WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field. Geneva, Switzerland 7-8 June 2004: http://www.who.int/bloodproducts/publications/en/ Minutes-220804.pdf
23. Gerlich W, Thomssen R: Standardized detection of hepatitis B surface antigen: determination of its serum concentration in weight units per volume. Develop Biol Standard 1975; 30:78-87
24. International Consortium for Blood Safety (ICBS), New York, USA & ICBS-Europe, Düsseldorf, Germany: HBV test kit evaluation results; http://www.icbs-web.org/page31.html
25. Takahashi K, Akahane Y, Hino K, Ohta Y, Mishiro S: Hepatitis B virus genomic sequence in the circulation of hepatocellular carcinoma patients: comparative analysis of 40 full-length isolates. Arch Virol 1998; 143:2313-2326
26. Deguchi M, Naoko Y, Masanori K, Seishi A, Yoshinori I, Takahiko T, Kazushige I, Mushahwar IK: Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay. J Virol Methods 2004; 115:217-222
27. Paul-Ehrlich-Institut: Explanations on How to Complete Application Forms for Approval of Test Sera and Test Antigens for the Detection of Viruses, 3rd edn. Langen/Germany, Paul-Ehrlich-Institut, 1999
28. Clinical and Laboratory Standards Institute (CLSI): Document ILA18-A2: Specifications for Immunological Testing for Infectious Diseases; Approved Guideline, 2nd edn. Wayne, PA, CLSI, 2001. Vol. 21, No. 15
29. The R Development Core Team: The R Foundation for Statistical Computing; R version 2.8.0, October 20, 2008 (http://www.r-project.org/)
30. Yoshikawa A, Gotanda Y, Minegishi K, Taira R, Hino S, Tadokoro K, Ohnuma H, Miyakawa K, Tachibana K, Mizoguchi H, Japanese Red Cross NAT Screening Research Group: Lengths of hepatitis B viremia and antigenemia in blood donors: preliminary evidence of occult (hepatitis B surface antigen-negative) infection in the acute stage. Transfusion 2007; 47:1162-1171
31. Lin YH, Wang Y, Loua A, Day GJ, Qiu Y, Nadala EC Jr, Allain JP, Lee HH: Evaluation of a new HBsAg rapid test with improved sensitivity. J Clin Microbiol 2008; 46:3319-3324
32. Swenson PD, Van Geyt C, Alexander ER, Hagan H, Freitag-Koontz JM, Wilson S, Norder H, Magnius LO, Stuyver L: Hepatitis B virus genotypes and HBsAg subtypes in refugees and injection drug users in the United States determined by LiPA and monoclonal EIA. J Med Virol 2001; 64:305-311
33. Ijaz S, Bridget Ferns R, Tedder RS: A 'first loop' linear epitope accessible on native hepatitis B surface antigen that persists in the face of 'second loop' immune escape. J Gen Virol 2003; 84:269-275
34. Mizuochi T, Okada Y, Umemori K, Mizusawa S, Sato S, Yamaguchi K: Reactivity of genotypically distinct hepatitis B virus surface antigens in 10 commercial diagnostic kits available in Japan. Jpn J Inf Dis 2005; 58:83-87
35. Mizuochi T, Okada Y, Umemori K: Evaluation of 10 commercial diagnostic kits for in vitro expressed hepatitis B virus (HBV) surface antigens encoded by HBV of genotypes A to H. J Virol Methods 2006; 136:254-256
36. Bartholomeusz A, Schäfer S: Hepatitis B virus genotypes: comparison of genotyping methods. Rev Med Virol 2004; 14:3-16
37. Olinger CM, Weber B, Otegbayo JA, Ammerlaan W, van der Taelem-Brulé N, Müller CP: Hepatitis B virus genotype E surface antigen detection with different immunoassays and diagnostic impact of mutations in the preS/S gene. Med Microbiol Immunol 2007; 196:247-252
38. Weber B, van der Taelem-Brulé N, Berger A, Simon F, Geudin M, Ritter J: Evaluation of two new automated assays for hepatitis B virus surface antigen (HBsAg) detection: IMMULITE HBsAg and IMMULITE 2000 HBsAg. J Clin Microbiol 2003; 41:135-143
39. Heijtink RA, van Bergen P, Melber K, Janowicz ZA, Osterhaus ADME: 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. Vaccine 2002; 20:2191-2196
40. Levicnik-Stezinar S: Hepatitis B surface antigen escape mutant in a first time blood donor potentially missed by a routine screening assay. Clin Lab 2004; 50:49-51