2007
DOI: 10.1007/s00430-007-0059-9
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Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants

Abstract: In a multicenter study a new, fully automated Roche Diagnostics Elecsys HBsAg II screening assay with improved sensitivity to HBsAg mutant detection was compared to well-established HBsAg tests: AxSYM HBsAg V2 (Abbott), Architect HBsAg (Abbott), Advia Centaur HBsAg (Bayer) Enzygnost HBsAg 5.0 (Dade-Behring), and Vitros Eci HBsAg (Ortho). A total of 16 seroconversion panels, samples of 60 HBsAg native mutants, and 31 HBsAg recombinant mutants, dilution series of NIBSC and PEI standards, 156 HBV positive samples… Show more

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Cited by 57 publications
(47 citation statements)
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“…Upstream (between 164 and 215) of MHR region of native and or recombinant surfance proteins has different binding capcities to antibodies. [9][10][11] Hence, the classical definition of the 'a' immunodominant region may need to be extended to require adjacent amino acids supporting its conformation. The amino acid sequence of the polymerase between aa163 and aa210 is the region that can confer resistance to some polymerase inhibitors, when mutated.…”
Section: Discussionmentioning
confidence: 99%
“…Upstream (between 164 and 215) of MHR region of native and or recombinant surfance proteins has different binding capcities to antibodies. [9][10][11] Hence, the classical definition of the 'a' immunodominant region may need to be extended to require adjacent amino acids supporting its conformation. The amino acid sequence of the polymerase between aa163 and aa210 is the region that can confer resistance to some polymerase inhibitors, when mutated.…”
Section: Discussionmentioning
confidence: 99%
“…HBs Ag and HCV Ab+ were detected by NIBSC 00/588; WHO 2nd International Standard for HBsAg, subtype adw2, genotype A; UI/mL with 99.9% specificity and 99.8% sensitivity (Muhlbacher et al, 2008) and hepatitis C antibody (Anti-HCV) by cobas e 411 analyzer, Elecsys® 2010 analyzer: 4.2 -5.2 % with100.0% sensitivity and 99.6% hospitalized patients clinical specificity (Esteban, 2013 ) …”
Section: Laboratory Methodsmentioning
confidence: 99%
“…Also, HBV detection methods differ in developed and developing countries according to the level of endemic HBV infections. Besides, automated HBsAg detection immunoassay systems have been developed and widely used [6][7][8][9]. However, high specificity enzyme-linked immunosorbent assays (ELISAs) are still commonly used [4,5,10,11].…”
Section: Article; Medical Biotechnology (Mb)mentioning
confidence: 99%