title: Evaluation of HPV 16 PCR detection in self- compared with clinician-collected samples in women referred for colposcopy.
abstract: OBJECTIVE
  A clinical prospective evaluation study was conducted to evaluate PCR detection of high-risk human papillomavirus (HPV) type 16 in self-sampled vaginal compared with clinician-collected cervical specimens.
  
  
  METHODS
  Paired vaginal and cervical specimens were collected from 137 consecutive women referred for colposcopy because of abnormal cervical cytology. In-house and a commercial PCR method for HPV type 16 were used. Self-sampled vaginal HPV 16 detection was compared to histology and physician-collected cervical specimens.
  
  
  RESULTS
  Of the 137 patients, 98 had proven abnormal histology and were included in the analysis. Overall, using the cervix HPV detection as reference method, the self-sampled vaginal sample showed sensitivity 91.8%, specificity 96.1% and agreement kappa (kappa) 0.881. Using the histology as reference, all 11 cervical cancer cases were HPV-16-positive in both cervical and vaginal samples, and in 43 high-grade lesions, detection sensitivity in cervix was 72.1% (kappa 0.588) and vagina 67.4% (kappa 0.516). HPV 16 detection did not differ (P=0.27) between clinician-collected cervical and self-sampled vaginal specimens.
  
  
  CONCLUSIONS
  The self-collected vaginal sample is highly concordant with the physician-collected cervical sample in HPV 16 detection.
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital of Larissa, Larissa, Greece. dapontea@otenet.gr
authors.forename: A
authors.initials: A
authors.lastname: Daponte
authors.forename: S
authors.initials: S
authors.lastname: Pournaras
authors.forename: I
authors.initials: I
authors.lastname: Mademtzis
authors.forename: C
authors.initials: C
authors.lastname: Hadjichristodoulou
authors.forename: E
authors.initials: E
authors.lastname: Kostopoulou
authors.forename: A N
authors.initials: AN
authors.lastname: Maniatis
authors.forename: I E
authors.initials: IE
authors.lastname: Messinis
mesh_terms: D002584:Cervix Uteri / Q000473:pathology* / Q000821:virology*; D003127:Colposcopy; D005260:Female; D052162:Human papillomavirus 16; D006801:Humans; D030361:Papillomavirus Infections / Q000473:pathology / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D012648:Self Care / Q000379:methods; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000821:virology; D014621:Vagina / Q000473:pathology* / Q000821:virology*; D014626:Vaginal Smears / Q000379:methods