Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection.

Details

Serval ID
serval:BIB_47F08714BB89
Type
Article: article from journal or magazin.
Collection
Publications
Title
Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection.
Journal
Journal of Medical Virology
Author(s)
Esteban J.I., van Helden J., Alborino F., Bürgisser P., Cellerai C., Pantaleo G., Eiras A., Rodriguez M.I., Ghisetti V., Gleich M., Imdahl R., Kaiser C., Möller P., Wetlitzky O., Segovia M., Schennach H., Mühlbacher A.
ISSN
1096-9071 (Electronic)
ISSN-L
0146-6615
Publication state
Published
Issued date
2013
Volume
85
Number
8
Pages
1362-1368
Language
english
Notes
Publication types: Journal ArticlePublication Status: ppublish
Abstract
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.
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Create date
02/07/2013 15:40
Last modification date
03/03/2018 16:51
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