title: Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population.
abstract: OBJECTIVE
  The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform.
  
  
  METHODS
  In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).
  
  
  RESULTS
  The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.
  
  
  CONCLUSIONS
  The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.
authors.affiliation: From Global Cancer Initiative, Chestertown, MD; castle.philip@gmail.com.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
authors.affiliation: Oklahoma University Health Sciences Center, Oklahoma City;
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Smith
authors.affiliation: Indiana University, Indianapolis;
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Davis
authors.affiliation: University of Texas, MD Anderson Cancer Center, Houston;
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Schmeler
authors.affiliation: Georgia Regents University, Augusta;
authors.forename: Daron G
authors.initials: DG
authors.lastname: Ferris
authors.affiliation: Medical University of South Carolina, Charleston;
authors.forename: Ashlyn H
authors.initials: AH
authors.lastname: Savage
authors.affiliation: University of Mississippi Medical Center, Jackson;
authors.forename: Jermaine E
authors.initials: JE
authors.lastname: Gray
authors.affiliation: University of Virginia, Charlottesville;
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: Columbia University, New York;
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Wright
authors.affiliation: McGill University and Jewish General Hospital, Montreal, Quebec, Canada; and.
authors.forename: Alex
authors.initials: A
authors.lastname: Ferenczy
authors.affiliation: Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
mesh_terms: D003127:Colposcopy; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods; D030361:Papillomavirus Infections / Q000175:diagnosis*; D012017:Referral and Consultation; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
keywords: Microbiology; Molecular diagnostics; Virology