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Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity

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Abstract

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.

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Acknowledgments

This study was supported by Roche Diagnostics GmbH, Germany. The authors wish to thank Walter Melchior, Roche Diagnostics GmbH, Germany, for assistance with the design and implementation of this study. The authors wish to thank the personnel of all laboratories that took part in the evaluation for their technical assistance.

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Authors and Affiliations

  1. Ospedale di Dolo, Servizio di Medicina di Laboratorio, Dolo, Italy

    F. Alborino & A. Burighel

  2. Medizinisches Versorgungszentrum, Futurebiolab, Munich, Germany

    F.-W. Tiller

  3. Medizinisches Versorgungszentrum, Labor Dr. Stein und Kollegen, Moenchengladbach, Germany

    J. van Helden

  4. Blutzentrale des Roten Kreuzes Oberoesterreich, Linz, Austria

    C. Gabriel

  5. Ospedale Santa Maria degli Angeli, Servizio Trasfusionale, Pordenone, Italy

    A. Raineri & R. Catapano

  6. Allgemeines Krankenhaus Linz, Zentrallabor, Linz, Austria

    H. Stekel

Authors
  1. F. Alborino
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  2. A. Burighel
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  3. F.-W. Tiller
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  4. J. van Helden
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  5. C. Gabriel
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  6. A. Raineri
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  7. R. Catapano
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  8. H. Stekel
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Correspondence to H. Stekel.

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Alborino, F., Burighel, A., Tiller, FW. et al. Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent sensitivity and specificity. Med Microbiol Immunol 200, 77–83 (2011). https://doi.org/10.1007/s00430-010-0171-0

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  • DOI: https://doi.org/10.1007/s00430-010-0171-0

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