Document Detail


Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection.
MedLine Citation:
PMID:  23765774     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Routine screening of patients at risk of hepatitis C virus (HCV) infection has become a priority given recent improvements in therapeutic options and the asymptomatic nature of most chronic infections. The aim of this study was to evaluate the performance of the Elecsys® Anti-HCV II assay, a new qualitative antibody immunoassay, compared with currently available assays, and assess its suitability for routine diagnostic testing. The sensitivity of the Elecsys® Anti-HCV II, ARCHITECT® Anti-HCV, AxSYM® HCV 3.0, PRISM® HCV, Vitros® ECi Anti-HCV, Elecsys® Anti-HCV, and ADVIA Centaur® HCV assays was compared using commercially available seroconversion panels and samples from patients known to be HCV positive and infected with HCV genotypes 1-6. Specificity was investigated using samples from blood donors, unselected hospitalized patients, and patients with potential cross-reacting factors or from high-risk groups. The Elecsys® Anti-HCV II assay detected more positive bleeds than the comparator assays, was more sensitive in recognizing early HCV infection, and correctly identified all 765 samples known to be HCV positive, regardless of genotype. The overall specificity of the Elecsys(®) Anti-HCV II assay was 99.84% (n = 6,850) using blood donor samples, 99.66% (n = 3,922) using samples from unselected hospitalized patients, and 99.66% (n = 2,397) using samples from patients with potentially cross-reacting factors or from high-risk groups. The specificity of the Elecsys® Anti-HCV II assay was superior or equal to the comparator assays. In conclusion, the Elecsys® Anti-HCV II assay is a sensitive and specific assay suitable for routine use in the reliable detection of anti-HCV antibodies. J. Med. Virol. 85:1362-1368, 2013. © 2013 Wiley Periodicals, Inc.
Authors:
Juan I Esteban; Josef van Helden; Flora Alborino; Philippe Bürgisser; Cristina Cellerai; Giuseppe Pantaleo; Adolfo Eiras; Maria I Rodriguez; Valeria Ghisetti; Michael Gleich; Roland Imdahl; Claudia Kaiser; Petra Möller; Olaf Wetlitzky; Manuel Segovia; Harald Schennach; Annelies Mühlbacher
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of medical virology     Volume:  85     ISSN:  1096-9071     ISO Abbreviation:  J. Med. Virol.     Publication Date:  2013 Aug 
Date Detail:
Created Date:  2013-06-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7705876     Medline TA:  J Med Virol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1362-8     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 Wiley Periodicals, Inc.
Affiliation:
Liver Unit, Vall d'Hebron University Hospital, Barcelona, Spain; Networked Biomedical Research Center Hepatic and Digestive Diseases (CIBEREHD), Institute of Health Carlos III, Madrid, Spain.
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