title: 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.
  
  
  OBJECTIVE
  The performance of the COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test was evaluated in a multi-center study.
  
  
  METHODS
  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.
authors.affiliation: University of Iowa, Roy J and Lucille A. Carver College of Medicine, Department of Pathology, 200 Hawkins Drive, Iowa City, IA 52242, USA. aaron-bossler@uiowa.edu
authors.forename: Aaron
authors.initials: A
authors.lastname: Bossler
authors.forename: Cynthia
authors.initials: C
authors.lastname: Gunsolly
authors.forename: Michael T
authors.initials: MT
authors.lastname: Pyne
authors.forename: Angela
authors.initials: A
authors.lastname: Rendo
authors.forename: Jane
authors.initials: J
authors.lastname: Rachel
authors.forename: Ray
authors.initials: R
authors.lastname: Mills
authors.forename: Marjorie
authors.initials: M
authors.lastname: Miller
authors.forename: John
authors.initials: J
authors.lastname: Sipley
authors.forename: David
authors.initials: D
authors.lastname: Hillyard
authors.forename: Stephen
authors.initials: S
authors.lastname: Jenkins
authors.forename: Cynthia
authors.initials: C
authors.lastname: Essmyer
authors.forename: Steve
authors.initials: S
authors.lastname: Young
authors.forename: Michael
authors.initials: M
authors.lastname: Lewinski
authors.forename: Hanna
authors.initials: H
authors.lastname: Rennert
mesh_terms: D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D012367:RNA, Viral / Q000097:blood*; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000295:instrumentation*; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral