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

Abstract Background Quantitative 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. Objectives The performance of the COBAS ® AmpliPrep/COBAS ® TaqMan ® HCV Test was evaluated in a multi-center study. Study design Typical plasma based specimens were tested for accuracy, analytic range of measurement, reproducibility and genotype specific quantitation. Results Linear regression analysis of the quantitative results demonstrated a linear range of detection from 50 to 5 million (1.7–6.7 log 10 ) IU/mL and a coefficient of determination ( R 2 ) 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 . Conclusions The COBAS ® AmpliPrep/COBAS ® TaqMan ® HCV Test is a reliable and sensitive assay for HCV RNA quantitation.