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Alborino, F; Burighel, A; Tiller, FW; van Helden, J; Gabriel, C; Raineri, A; Catapano, R; Stekel, H.
Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity.
Med Microbiol Immunol. 2011; 200(2): 77-83.
Doi: 10.1007/s00430-010-0171-0
Web of Science
PubMed
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- Co-authors Med Uni Graz
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GABRIEL Christian
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Early detection of hepatitis C virus (HCV) is an important step in preventing progression to cirrhosis and hepatocellular carcinoma. Serologic assays for anti-hepatitis C (anti-HCV) antibody are valuable first-line tests in the screening and diagnosis of HCV infection. The aim of this multicenter study was to compare the Elecsys(®) Anti-HCV assay with alternative CE-marked Anti-HCV antibody assays against a range of samples that included 1,138 blood donors, 3,553 unselected routine daily specimens, and 46 pre-selected seroconversion panels. Specificity of the Elecsys Anti-HCV assay was 99.5% with blood donor samples and 99.4% with routine clinical specimens. These were similar to those obtained with the Prism(®) Anti-HCV, Architect(®) Anti-HCV assay, ADVIA(®) Centaur Anti-HCV assay and Vitros(®) Eci aHCV assays. Seroconversion sensitivity for the Elecsys Anti-HCV assay was similar to that of the Architect Anti-HCV, AxSYM HCV version 3.0, ADVIA Centaur Anti-HCV, and Vitros Eci aHCV assays. In fact, seroconversion testing on 46 commercially available panels showed that the difference in first detecting a positive blood sample was less than one day between assays (not statistically significant). The Elecsys Anti-HCV assay as well as the Architect, Prism, and Vitros Anti-HCV immunoassays revealed a seroconversion sensitivity of 100%, whereas the ADVIA Centaur HCV immunoassay showed a sensitivity of only 97.5% (39/40). Overall, the performance of the Elecsys Anti-HCV assay was similar to the performances of the comparator CE-marked Anti-HCV antibody assays.
- Find related publications in this database (using NLM MeSH Indexing)
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Automation -
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Hepacivirus - immunology
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Hepatitis C - diagnosis Hepatitis C - immunology Hepatitis C - virology
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Hepatitis C Antibodies - blood
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Humans -
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Mass Screening - methods
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Reagent Kits, Diagnostic -
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Sensitivity and Specificity -
- Find related publications in this database (Keywords)
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Hepatitis C virus
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Anti-HCV antibody screening
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Elecsys Anti-HCV
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Architect Anti-HCV
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ADVIA Centaur Anti-HCV
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Vitros Eci aHCV