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

J Clin Microbiol. 2008 Dec;46(12):3919-23. doi: 10.1128/JCM.01603-08. Epub 2008 Oct 22.

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%.

Publication types

  • Evaluation Study

MeSH terms

  • Automation
  • Hepatitis C / diagnosis*
  • Hepatitis C Antibodies / blood*
  • Humans
  • Immunoassay / methods*
  • Luminescence*
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Hepatitis C Antibodies