title: Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: high concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN.
abstract: BACKGROUND
  Studies have shown that self-sampling for hrHPV testing (HPV self-sampling) is highly acceptable to women, increases screening participation rate, and may therefore further reduce cervical cancer incidence. However, it is important to clinically validate HPV self-sampling procedures for screening purposes.
  
  
  OBJECTIVE
  Clinical validation of combined brush-based self-sampling with GP5+/6+-PCR EIA for primary cervical screening. In addition, HPV type-specific agreement between sample types and acceptability of brush-based self-sampling were evaluated.
  
  
  METHODS
  135 women referred for colposcopy took a self-sample at home prior to vaginal- and cervical sampling by a gynaecologist. All women were biopsied for histology. HPV testing was done by GP5+/6+-PCR EIA, with genotyping by reverse line blotting (RLB). Acceptability of sampling methods was measured with a questionnaire.
  
  
  RESULTS
  In this outpatient population, hrHPV test results showed good concordance between self-samples and physician-taken cervical scrapes (86%, k=0.70), with sensitivities and specificities for CIN2+ that did not differ significantly (93% and 51%, 91% and 51%, respectively (P=1.0)). The clinical sensitivity of brush-based self-sampling combined with GP5+/6+-PCR EIA hrHPV testing for detection of CIN2+ was non-inferior to that of hrHPV testing on physician-taken cervical samples (P=0.018). In addition, hrHPV genotyping results were highly concordant between sample types, with almost perfect agreement for HPV16 (k=0.81) and HPV18 (k=0.92). Finally, 91% of participants described brush-based self-sampling as easy-to-use.
  
  
  CONCLUSIONS
  Brush-based self-sampling in combination with GP5+/6+-PCR EIA hrHPV testing is acceptable to women and valid for assessing the risk of CIN2+ in comparison to hrHPV testing on physician-taken scrapes. In addition, there was high concordance of HPV genotyping results. Therefore, this HPV self-sampling procedure may be considered for use in routine cervical screening.
authors.affiliation: Department of Pathology, VU University Medical Center, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands.
authors.forename: Maaike G
authors.initials: MG
authors.lastname: Dijkstra
authors.forename: Daniëlle A M
authors.initials: DA
authors.lastname: Heideman
authors.forename: Folkert J
authors.initials: FJ
authors.lastname: van Kemenade
authors.forename: Kees J A
authors.initials: KJ
authors.lastname: Hogewoning
authors.forename: Albertus T
authors.initials: AT
authors.lastname: Hesselink
authors.forename: Muriël C G T
authors.initials: MC
authors.lastname: Verkuijten
authors.forename: W Marchien
authors.initials: WM
authors.lastname: van Baal
authors.forename: Gatske M Nieuwenhuyzen-de
authors.initials: GM
authors.lastname: Boer
authors.forename: Peter J F
authors.initials: PJ
authors.lastname: Snijders
authors.forename: Chris J L M
authors.initials: CJ
authors.lastname: Meijer
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D016133:Polymerase Chain Reaction / Q000379:methods; D016353:Self-Examination / Q000379:methods*; D013048:Specimen Handling / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*