title: Fully automated quantification of hepatitis C virus (HCV) RNA in human plasma and human serum by the COBAS AmpliPrep/COBAS TaqMan system.
abstract: BACKGROUND
  HCV RNA is commonly recognized as key parameter for reliable diagnosis and treatment monitoring of HCV infection. Determination of blood HCV RNA concentrations reduces the pre-seroconversion period in the diagnosis of HCV infection and supports management of interferon alpha-based therapies of chronic HCV infection.
  
  
  OBJECTIVE
  The COBAS AmpliPrep/COBAS TaqMan HCV Test combines automated extraction of nucleic acids on the COBAS AmpliPrep Instrument with real-time PCR on the COBAS TaqMan Analyzer, thus greatly reducing hands-on time during sample preparation and amplification/detection. The test, which is calibrated to the 1st International HCV WHO Standard, was evaluated for sensitivity, dynamic range, precision, matrix equivalence, genotype inclusivity, interfering substances, diagnostic and analytical specificity, as well as for correlation with two other commercial tests for HCV RNA quantification.
  
  
  RESULTS
  The COBAS AmpliPrep/COBAS TaqMan HCV Test demonstrated a >6-log dynamic range of 43-6.90 E+7 IU/mL, a sensitivity (95% hit rate) of at least 15 IU/mL for HCV WHO Standard and a comparable quantification of genotypes 1-6. HCV quantification results were in good correlation with those obtained by the COBAS AMPLICOR HCV MONITOR Test v2.0 and the VERSANT HCV RNA 3.0 test.
  
  
  CONCLUSIONS
  The fully automated COBAS AmpliPrep/COBAS TaqMan HCV Test excellently accomplishes the requirements for highly sensitive detection and reliable quantification of HCV in clinical samples and thus improves therapy monitoring and management of HCV infection.
authors.affiliation: Roche Molecular Systems, Roche Diagnostics GmbH, Werk Penzberg, Nonnenwald 2, 82377 Penzberg, Germany.
authors.forename: Dorothea
authors.initials: D
authors.lastname: Sizmann
authors.forename: Claudia
authors.initials: C
authors.lastname: Boeck
authors.forename: Juergen
authors.initials: J
authors.lastname: Boelter
authors.forename: Daniela
authors.initials: D
authors.lastname: Fischer
authors.forename: Marion
authors.initials: M
authors.lastname: Miethke
authors.forename: Stefan
authors.initials: S
authors.lastname: Nicolaus
authors.forename: Markus
authors.initials: M
authors.lastname: Zadak
authors.forename: Reiner
authors.initials: R
authors.lastname: Babiel
mesh_terms: D000704:Analysis of Variance; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification / Q000502:physiology; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D010949:Plasma / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D044967:Serum / Q000821:virology*; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral