title: A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off.
abstract: BACKGROUND
  High-risk human papillomavirus (HR HPV) testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical pre-cancer and cancer.
  
  
  METHODS
  We report a purely observational study evaluating HR HPV prevalences in residual liquid-based cytology (LBC) samples using both the Cervista™ HPV HR Test and the Digene Hybrid Capture 2 High-Risk HPV DNA Test (HC2) in a sample of 1,741 women aged ≥30 years of a German routine screening population of 13,372 women. Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.
  
  
  RESULTS
  The overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8). Relative sensitivities for the detection of histologically confirmed severe cervical intraepithelial dysplasia (CIN3+) were similar for both HPV-tests, which was confirmed by the ratio analysis. However, discrepancy analysis between the Cervista HPV HR test and HC2 revealed a high false positive rate of the Cervista HPV HR test in the cytology normal category.
  
  
  CONCLUSIONS
  Performance of the Cervista HPV test in cervical specimens with abnormal cytology is comparable to HC2 as both tests were highly sensitive and specific for the detection of high grade cervical disease. We also demonstrate evidence that modification of the cut-off values drastically reduces the false positive rate in the cytology normal category without affecting the detection of CIN3+, which ultimately improved specificity of the Cervista HPV HR assay.
authors.affiliation: German Clinic Bad Münder, Bad Münder, Germany. Boehmer@izd-hannover.de.
authors.forename: Gerd
authors.initials: G
authors.lastname: Boehmer
authors.affiliation: Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Tübingen, Germany. Lisa.wang@med.uni-tuebingen.de.
authors.forename: Lisa
authors.initials: L
authors.lastname: Wang
authors.affiliation: Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, 72076, Tübingen, Germany. Angelika.iftner@med.uni-tuebingen.de.
authors.forename: Angelika
authors.initials: A
authors.lastname: Iftner
authors.affiliation: Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, 72076, Tübingen, Germany. Barbara.holz@med.uni-tuebingen.de.
authors.forename: Barbara
authors.initials: B
authors.lastname: Holz
authors.affiliation: Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, 72076, Tübingen, Germany. Juliane.haedicke@med.uni-tuebingen.de.
authors.forename: Juliane
authors.initials: J
authors.lastname: Haedicke
authors.affiliation: German Clinic Bad Münder, Bad Münder, Germany. Reinhard.vonWasielewski@krh.eu.
authors.forename: Reinhard
authors.initials: R
authors.lastname: von Wasielewski
authors.affiliation: Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Tübingen, Germany. Peter.martus@med.uni-tuebingen.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Martus
authors.affiliation: Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, 72076, Tübingen, Germany. Thomas.iftner@med.uni-tuebingen.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Iftner
mesh_terms: D000328:Adult; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000175:diagnosis* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology