Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection

Sinyoung Kim, Jeong Ho Kim, Seoyoung Yoon, Youn Hee Park, Hyon Suk Kim

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Various automated chemiluminescence immunoassay (CLIA) analyzers for the detection of antibodies to hepatitis C virus (HCV) are now commercially available in clinical laboratories and are replacing conventional enzyme immunoassays. We investigated the performance of four anti-HCV CLIAs (the Architect Anti-HCV assay on the Architect i2000 system, the Vitros Anti-HCV assay on the Vitros ECiQ Immunodiagnostic System, the Access HCV Ab PLUS assay on the UniCel DxI 800 analyzer, and the newly developed Elecsys Anti-HCV assay on the Cobas e 411 analyzer). The total percent coefficient of variation values of imprecision were 3.5 to 5.7% with positive control materials and 7.2 to 10.2% with negative control materials. The agreement between the results of the Elecsys, Architect, Vitros, and Access CLIAs ranged from 94.5 to 98.1%. The clinical sensitivity of all CLIAs was 100%. Each CLIA showed excellent reproducibility and clinical sensitivity. The Elecsys, Architect, Vitros, and Access CLIAs showed clinical specificities of 98.2, 98.8, 96.5, and 98.2%.

Original languageEnglish
Pages (from-to)3919-3923
Number of pages5
JournalJournal of Clinical Microbiology
Volume46
Issue number12
DOIs
Publication statusPublished - 2008 Dec 1

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Hepatitis C Antibodies
Luminescence
Immunoassay
Hepacivirus
Immunoenzyme Techniques

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)

Cite this

Kim, Sinyoung ; Kim, Jeong Ho ; Yoon, Seoyoung ; Park, Youn Hee ; Kim, Hyon Suk. / Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. In: Journal of Clinical Microbiology. 2008 ; Vol. 46, No. 12. pp. 3919-3923.
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abstract = "Various automated chemiluminescence immunoassay (CLIA) analyzers for the detection of antibodies to hepatitis C virus (HCV) are now commercially available in clinical laboratories and are replacing conventional enzyme immunoassays. We investigated the performance of four anti-HCV CLIAs (the Architect Anti-HCV assay on the Architect i2000 system, the Vitros Anti-HCV assay on the Vitros ECiQ Immunodiagnostic System, the Access HCV Ab PLUS assay on the UniCel DxI 800 analyzer, and the newly developed Elecsys Anti-HCV assay on the Cobas e 411 analyzer). The total percent coefficient of variation values of imprecision were 3.5 to 5.7{\%} with positive control materials and 7.2 to 10.2{\%} with negative control materials. The agreement between the results of the Elecsys, Architect, Vitros, and Access CLIAs ranged from 94.5 to 98.1{\%}. The clinical sensitivity of all CLIAs was 100{\%}. Each CLIA showed excellent reproducibility and clinical sensitivity. The Elecsys, Architect, Vitros, and Access CLIAs showed clinical specificities of 98.2, 98.8, 96.5, and 98.2{\%}.",
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Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. / Kim, Sinyoung; Kim, Jeong Ho; Yoon, Seoyoung; Park, Youn Hee; Kim, Hyon Suk.

In: Journal of Clinical Microbiology, Vol. 46, No. 12, 01.12.2008, p. 3919-3923.

Research output: Contribution to journalArticle

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