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

Journal of Medical Virology

Volumn 78, Issue SUPPL. 1, 2006, Pages

  Scheiblauer, Heiner ^a   Soboll, Heidemarie ^a   Nick, Sigrid ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

Author keywords

HBsAg; HBV mutants

Indexed keywords

HEPATITIS B SURFACE ANTIGEN; MONOCLONAL ANTIBODY;

ARTICLE; EUROPE; HEPATITIS B VIRUS; IMMUNOASSAY; SENSITIVITY AND SPECIFICITY; SEROCONVERSION; VIRUS DETECTION; VIRUS MUTANT; VIRUS RECOMBINANT;

ANTIBODIES, MONOCLONAL; EUROPE; FALSE NEGATIVE REACTIONS; HEPATITIS ANTIBODIES; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HUMANS; IMMUNOASSAY; MUTATION; RECOMBINATION, GENETIC; SENSITIVITY AND SPECIFICITY;

HEPATITIS B VIRUS;

EID: 33745601414     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.20611     Document Type: Article

References (10)

1. Coleman PF, Chen YC, Mushahwar IK. 1999. Immunoassay detection of hepatitis B surface antigen mutants. J Med Virol 59: 19-24.
2. Common technical specifications: Commission Decision 2002/364/EC of 7 May 2002. 2002. On common technical specifications for in vitro-diagnostic medical devices [Official Journal L 131 of 16.05.2002].
3. Echevarria JM, Avellon A, Magnius LO. 2005. Molecular epidemiology of hepatitis B virus in Spain: Identification of viral genotypes and prediction of antigenic subtypes by limited sequencing. J Med Virol 76:176-184.
4. Levicnik-Stezinar S. 2004. Hepatitis B surface antigen escape mutant in a first time blood donor potentially missed by a routine screening assay. Clin Lab 50:49-51.
5. Moerman B, Moons V, Sommer H, Schmitt Y, Stetter M. 2004. Evaluation of sensitivity for wild type and mutant forms of hepatitis B surface antigen by four commercial HBsAg assays. Clin Lab 50: 159-162.
6. Nick S, Soboll H, Unger G, Halbauer J, Wilhelm M, Löwer J, Bornhak H. 1998. Results of the Re-Evaluation of HIV, HCV and HBsAg Screening Tests by the Paul-Ehrlich-Institut. European Society for Clinical Virology. Progress in Clinical Virology IV. Hamburg.
7. Scicluna L, Sallett K, Keith R, Perry KR, John V, Parry JV. 2003. DIA.PRO HBsAg One-Step EIA Evaluation Report MHRA NUMBER 03031.
8. Weber B. 2005. Genetic variability of the S gene of hepatitis B virus: Clinical and diagnostic impact. J Clin Virol 32:102-112.
9. Westhoff TH, Jochimsen F, Schmittel A, Stöffler-Meilicke M, Schafer JH, Zidek W, Gerlich WH, Thiel E. 2003. Fatal hepatitis B virus reactivation by an escape mutant following rituximab therapy. Blood 102:1930.
10. Zaaijer HL, Vrielink H, Root M. 2001. Early detection of hepatitis B surface antigen and detection of HBsAg mutants: A comparison of five assays. Vox Sang 81:219-221.