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Published on: September 10, 2018
Multicenter evaluation of a fully automated third-generation anti-HCV antibody screening test with excellent
F Alborino1, A Burighel, F-W Tiller
1Ospedale di Dolo, Servizio di Medicina di Laboratorio, Dolo, Italy.
Insights
Early detection of hepatitis C virus (HCV) is crucial. This study found the Elecsys Anti-HCV assay performs comparably to other CE-marked antibody tests in detecting HCV infection, ensuring reliable screening.
Area of Science:
- Clinical diagnostics
- Virology
- Immunology
Background:
- Early detection of hepatitis C virus (HCV) is vital for preventing severe liver disease, including cirrhosis and hepatocellular carcinoma.
- Serologic assays for anti-hepatitis C (anti-HCV) antibodies are primary tools for screening and diagnosing HCV infection.
Purpose of the Study:
- To evaluate and compare the performance of the Elecsys Anti-HCV assay against other CE-marked anti-HCV antibody assays.
- To assess diagnostic accuracy, specifically specificity and seroconversion sensitivity, in a multicenter setting.
Main Methods:
- A multicenter study involving 1,138 blood donors and 3,553 routine clinical specimens.
- Comparison of the Elecsys Anti-HCV assay with alternative CE-marked anti-HCV antibody assays, including Prism, Architect, ADVIA Centaur, and Vitros Eci.
- Evaluation using 46 pre-selected seroconversion panels to determine early detection capabilities.
Main Results:
- The Elecsys Anti-HCV assay demonstrated high specificity (99.5% in blood donors, 99.4% in routine specimens), comparable to comparator assays.
- Seroconversion sensitivity was similar across most tested assays, with Elecsys, Architect, Prism, and Vitros achieving 100% sensitivity.
- The ADVIA Centaur HCV immunoassay showed a slightly lower seroconversion sensitivity of 97.5%.
Conclusions:
- The Elecsys Anti-HCV assay exhibits performance characteristics similar to other CE-marked anti-HCV antibody assays.
- The assay is a reliable option for the first-line screening and diagnosis of hepatitis C virus infection.
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.
