title: Comparison of the Roche Cobas(®) 4800 HPV assay to Digene Hybrid Capture 2, Roche Linear Array and Roche Amplicor for Detection of High-Risk Human Papillomavirus Genotypes in Women undergoing treatment for cervical dysplasia.
abstract: BACKGROUND
  The recently FDA (U.S. food and drug administration) approved Roche Cobas(®) 4800 (Cobas) human papillomavirus (HPV) has limited performance data compared to current HPV detection methods for test of cure in women undergoing treatment for high grade lesions.
  
  
  OBJECTIVE
  Evaluation of Cobas HPV assay using historical samples from women undergoing treatment for cervical dysplasia.
  
  
  METHODS
  A selection of 407 samples was tested on the Cobas assay and compared to previous results from Hybrid Capture 2, HPV Amplicor and Roche Linear Array.
  
  
  RESULTS
  Overall, a correlation between high-risk HPV positivity and high grade histological diagnosis was 90.6% by the Cobas, 86.1% by Hybrid Capture 2, 92.9% by HPV Amplicor and 91.8% by Roche Linear Array.
  
  
  CONCLUSIONS
  The Cobas HPV assay is comparative to both the HPV Amplicor and Roche Linear Array assays and better than Hybrid capture 2 assay in the detection of High-Risk HPV in women undergoing treatment for cervical dysplasia.
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria 3052, Australia.
authors.forename: Samuel
authors.initials: S
authors.lastname: Phillips
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia; Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria 3052, Australia.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Oncology and Dysplasia Unit, Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Jeffery H
authors.initials: JH
authors.lastname: Tan
authors.affiliation: Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Oncology and Dysplasia Unit, Royal Women's Hospital, Parkville, Victoria, Australia.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Quinn
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia; Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia; Murdoch Childrens Research Institute, Parkville, Victoria 3052, Australia. Electronic address: sepehr.tabrizi@thewomens.org.au.
authors.forename: Sepehr N
authors.initials: SN
authors.lastname: Tabrizi
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D004279:DNA, Viral; D005260:Female; D005838:Genotype; D006801:Humans; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000821:virology*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000188:drug therapy / Q000473:pathology / Q000821:virology*
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Amplicor; Diagnostic; Human papillomavirus; Hybrid capture; Linear array; Roche Cobas