title: Accuracy of HPV testing of vaginal smear obtained with a novel self-sampling device.
abstract: BACKGROUND
  Most of women diagnosed as having cervical cancer have not participated in organized cytological screening. Aim. A study was conducted to evaluate the accuracy of human papilloma virus testing by self-collected vaginal samples in comparison to regular cytological screening. The agreement of hybrid capture 2 assay and polymerase chain reaction assay for detection of human papilloma virus DNA in self-collected vaginal samples and clinician-obtained cervical smears was investigated.
  
  
  METHODS
  Forty-three women aged 23-58 years admitted for further examination due to previous positive cytology in the organized screening participated in self-collecting of vaginal samples with a novel self-sampling device. During the visit a clinician also collected a cervical smear using a cytobrush. The vaginal samples collected with the self-sampling device were analyzed for high-risk human papilloma virus with the hybrid capture 2 assay technique and the cervical smears were Pap-stained, examined cytologically and after that reanalyzed for human papilloma virus DNA using a polymerase chain reaction assay.
  
  
  RESULTS
  The vaginal samples were positive for high-risk human papilloma virus in 37% of the cases using hybrid capture 2 assay. Twelve of the 43 Pap smears showed positive cytology (ASCUS-CIN 3), of which 4 showed CIN 2-3. When polymerase chain reaction assay was performed, human papilloma virus DNA was detected in 40% of the glass slides. The agreement between cytology and the two human papilloma virus testing techniques was 67-74% (kappa 0.27-0.45) and the agreement between the two human papilloma virus tests was 70% (kappa 0.36).
  
  
  CONCLUSIONS
  Testing for high-risk human papilloma virus can identify more women at risk of developing cervical cancer than cytology irrespective of the sampling method. Furthermore, offering a self-sampling device for collection of vaginal smear seems to be a useful screening tool for cervical cancer among women not responding to an invitation for smear sampling.
authors.affiliation: Department of Genetics and Pathology, University Hospital of Uppsala, Sweden.
authors.forename: Harriet
authors.initials: H
authors.lastname: Stenvall
authors.forename: Ingrid
authors.initials: I
authors.lastname: Wikström
authors.forename: Ingrid
authors.initials: I
authors.lastname: Backlund
authors.forename: Erik
authors.initials: E
authors.lastname: Wilander
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D011237:Predictive Value of Tests; D012648:Self Care; D013548:Sweden / Q000453:epidemiology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control / Q000821:virology; D014626:Vaginal Smears / Q000295:instrumentation*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control / Q000821:virology
chemical_list: D004279:DNA, Viral