1. Performance of the COBAS® AmpliPrep/COBAS TaqMan® automated system for hepatitis C virus (HCV) quantification in a multi-center comparison
- Author
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Cynthia Essmyer, Cynthia Gunsolly, Steve Young, Hanna Rennert, Michael A. Lewinski, Aaron D. Bossler, Jane Rachel, David R. Hillyard, Marjorie J. Miller, Stephen G. Jenkins, Angela Rendo, John Sipley, Michael T. Pyne, and Ray Mills
- Subjects
Standard of care ,Genotype ,business.industry ,Cobas taqman ,Reverse Transcriptase Polymerase Chain Reaction ,Hepatitis C virus ,HCV genotypes ,Reproducibility of Results ,Hepacivirus ,medicine.disease_cause ,Virology ,Sensitivity and Specificity ,Infectious Diseases ,TaqMan ,Medicine ,Humans ,RNA, Viral ,business ,Specimen processing ,Viral load - 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.
- Published
- 2010