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

• Published in: Journal of virological methods Vol. 86; no. 1; pp. 55 - 60
• Main Authors: Afonso, Anne Marie Roque, Didier, Josiane, Plouvier, Elisabeth, Falissard, Bruno, Ferey, Marie Pierre, Bogard, Marc, Dussaix, Elisabeth
• Format: Journal Article
• Language: English
• Published: London Elsevier B.V 01.04.2000; Amsterdam Elsevier; New York, NY
• Subjects: Automation; Biological and medical sciences; Evaluation Studies as Topic; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis C - diagnosis; Hepatitis C - virology; Hepatitis C virus; Human viral diseases; Humans; Infectious diseases; Medical sciences; Polymerase Chain Reaction - methods; Quantitative polymerase chain reaction; Reagent Kits, Diagnostic; Reproducibility of Results; RNA, Viral - blood; Routine diagnostic laboratory; Sensitivity and Specificity; Viral diseases; Viral hepatitis; Automation; Quantitative polymerase chain reaction; Hepatitis C virus; Routine diagnostic laboratory; Performance evaluation; Human; RNA; Hepatic disease; Method; Automated processing; Infection; Virus; Polymerase chain reaction; Viral disease; Laboratory investigations; Digestive diseases; Diagnosis; Flaviviridae; Hepacivirus; Quantitative analysis; Viral hepatitis C
• ISSN: 0166-0934; 1879-0984
• DOI: 10.1016/S0166-0934(99)00179-2

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 1 log 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.