title: Randomized Comparison of Two Vaginal Self-Sampling Methods for Human Papillomavirus Detection: Dry Swab versus FTA Cartridge.
abstract: BACKGROUND
  Human papillomavirus (HPV) self-sampling (self-HPV) is valuable in cervical cancer screening. HPV testing is usually performed on physician-collected cervical smears stored in liquid-based medium. Dry filters and swabs are an alternative. We evaluated the adequacy of self-HPV using two dry storage and transport devices, the FTA cartridge and swab.
  
  
  METHODS
  A total of 130 women performed two consecutive self-HPV samples. Randomization determined which of the two tests was performed first: self-HPV using dry swabs (s-DRY) or vaginal specimen collection using a cytobrush applied to an FTA cartridge (s-FTA). After self-HPV, a physician collected a cervical sample using liquid-based medium (Dr-WET). HPV types were identified by real-time PCR. Agreement between collection methods was measured using the kappa statistic.
  
  
  RESULTS
  HPV prevalence for high-risk types was 62.3% (95%CI: 53.7-70.2) detected by s-DRY, 56.2% (95%CI: 47.6-64.4) by Dr-WET, and 54.6% (95%CI: 46.1-62.9) by s-FTA. There was overall agreement of 70.8% between s-FTA and s-DRY samples (kappa = 0.34), and of 82.3% between self-HPV and Dr-WET samples (kappa = 0.56). Detection sensitivities for low-grade squamous intraepithelial lesion or worse (LSIL+) were: 64.0% (95%CI: 44.5-79.8) for s-FTA, 84.6% (95%CI: 66.5-93.9) for s-DRY, and 76.9% (95%CI: 58.0-89.0) for Dr-WET. The preferred self-collection method among patients was s-DRY (40.8% vs. 15.4%). Regarding costs, FTA card was five times more expensive than the swab (~5 US dollars (USD)/per card vs. ~1 USD/per swab).
  
  
  CONCLUSIONS
  Self-HPV using dry swabs is sensitive for detecting LSIL+ and less expensive than s-FTA.
  
  
  BACKGROUND
  International Standard Randomized Controlled Trial Number (ISRCTN): 43310942.
authors.affiliation: Division of Gynecology, Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.|Faculty of Medicine, University of Geneva, Geneva, Switzerland.
authors.forename: Rosa
authors.initials: R
authors.lastname: Catarino
authors.affiliation: Geneva Foundation for Medical Education and Research, Geneva, Switzerland.
authors.forename: Pierre
authors.initials: P
authors.lastname: Vassilakos
authors.affiliation: Division of Gynecology, Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Aline
authors.initials: A
authors.lastname: Bilancioni
authors.affiliation: Division of Gynecology, Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Vanden Eynde
authors.affiliation: Division of Gynecology, Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Meyer-Hamme
authors.affiliation: Unilabs SA, Lausanne, Switzerland.
authors.forename: Pierre-Alain
authors.initials: PA
authors.lastname: Menoud
authors.affiliation: Unilabs SA, Lausanne, Switzerland.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Guerry
authors.affiliation: Division of Gynecology, Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Petignat
mesh_terms: D000328:Adult; D005260:Female; D005838:Genotype; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification* / Q000502:physiology; D013048:Specimen Handling / Q000295:instrumentation / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology