Evaluation of the performance of the EIAgen HCV test for detection of hepatitis C virus infection

J Virol Methods. 2009 Dec;162(1-2):203-7. doi: 10.1016/j.jviromet.2009.08.008. Epub 2009 Aug 22.

Abstract

The EIAgen HCV test (Adaltis Inc., Montreal, Canada) is an enzyme immunoassay (EIA) for the detection of anti-hepatitis C virus (HCV) antibodies. This study compared the performance of this test side-by-side with the current Ortho HCV 3.0 Anti-HCV assay (Ortho-Clinical Diagnostics Inc., Johnson & Johnson Company, Raritan, NY, USA). Among 2559 specimens examined, 178 were true positives, 2376 were true negatives and 5 were indeterminate. The sensitivity of the EIAgen HCV test was 100%, versus 98.3% for the Ortho HCV test, while their respective specificities were 98.1% and 98.2%. The EIAgen HCV test gave a positive predictive value of 79.8% and a negative predictive value of 100%. Overall, the concordance of this test with the Ortho HCV test was 98.2%. Specimens from potentially interfering substances, such as sera from pregnant women, sera from patients with acute non-C hepatitis, autoimmune diseases, lipidemia, or from patients undergoing hemolysis, showed no interference with either EIA. An EIAgen HCV test signal-to-cut-off ratio of >5.9 would be highly predictive of a true-positive finding in these specimens. The EIAgen HCV test is well suited for screening blood and blood products in antibodies to HCV.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • False Positive Reactions
  • Female
  • Hepacivirus / immunology*
  • Hepatitis C / diagnosis*
  • Hepatitis C / immunology
  • Hepatitis C / virology
  • Hepatitis C Antibodies / blood*
  • Humans
  • Immunoenzyme Techniques / methods*
  • Predictive Value of Tests
  • Pregnancy
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity

Substances

  • Hepatitis C Antibodies
  • Reagent Kits, Diagnostic