Performance of the COBAS® AmpliPrep/COBAS TaqMan® automated system for hepatitis C virus (HCV) quantification in a multi-center comparison

BackgroundQuantitative HCV RNA testing is considered standard of care for monitoring during treatment of patients infected with HCV. The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test fully automates specimen processing and reaction assembly for HCV viral load testing using reverse transcription and real-time PCR amplification.ObjectivesThe performance of the COBAS® AmpliPrep/COBAS® TaqMan® HCV Test was evaluated in a multi-center study.Study designTypical plasma based specimens were tested for accuracy, analytic range of measurement, reproducibility and genotype specific quantitation.ResultsLinear regression analysis of the quantitative results demonstrated a linear range of detection from 50 to 5 million (1.7–6.7 log10) IU/mL and a coefficient of determination (R2) of 0.9948. The precision of the assay was highly reproducible within and between runs and among laboratories with coefficients of variance (CV) ranging from 6.7% to 40.0% across the seven laboratories. A representative sample for each of the six major HCV genotypes demonstrated reproducible quantitation between the seven laboratories.ConclusionsThe COBAS® AmpliPrep/COBAS® TaqMan® HCV Test is a reliable and sensitive assay for HCV RNA quantitation.