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

The Amplicor HCV Monitor(TM) test for quantitative determination of serum or plasma hepatitis C Virus (HCV) RNA was modified recently and introduced onto the Cobas Amplicor(TM) 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. (C) 2000 Elsevier Science B.V. All rights reserved.