Performance of an automated system for quantification of hepatitis C virus RNA

J Virol Methods. 2000 Apr;86(1):55-60. doi: 10.1016/s0166-0934(99)00179-2.

Abstract

The Amplicor HCV Monitor test for quantitative determination of serum or plasma hepatitis C virus (HCV) RNA was modified recently and introduced onto the Cobas Amplicor instrument to automate fully amplification, detection and calculation of results. This new version (v2.0) was evaluated in a routine diagnostic laboratory. The sensitivity and reproducibility were assessed on well-characterized panels (Eurohep) and clinical samples. HCV RNA levels measured by the v2.0 Monitor test were about 1log(10) higher than those detected by the previous version test, and genotypes 1 and 3 were quantified with equal sensitivity. Within the linear dynamic range of 10(3) to 10(6) copies/ml, the coefficients of variation for both intra- and inter-assay reproducibility ranged from 1.9 to 2.95%. This test system was found to be a reliable and labor saving assay for the quantification of HCV RNA.

MeSH terms

  • Automation
  • Evaluation Studies as Topic
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification*
  • Hepatitis C / diagnosis*
  • Hepatitis C / virology
  • Humans
  • Polymerase Chain Reaction / methods*
  • RNA, Viral / blood*
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • RNA, Viral
  • Reagent Kits, Diagnostic