title: Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women.
abstract: Primary screening using high-risk human papillomavirus (hrHPV) detection has been suggested as a way of improving cervical cancer prevention. Women currently not attending screening (nonresponders) are more likely to participate when given the opportunity of self-sampling for hrHPV testing. The Evalyn Brush is a new cervicovaginal self-sampling device, developed specifically to meet women's demands, which is user-friendly and easy to use. The aims of this study were to investigate agreement of hrHPV detection by two PCR methods between the Evalyn Brush and physician-obtained samples and to study women's acceptance of this self-sampling device. Each of 134 women visiting the gynecology outpatient clinic collected a self-obtained sample (self-sample) and completed a questionnaire. The brush was stored dry. After self-sampling, a trained physician obtained a conventional cervical cytology specimen in ThinPrep medium. HrHPV detection was performed using the SPF(10)-DEIA-LiPA(25) and GP5+/6+-LQ-test. The overall agreement for hrHPV detection using SPF(10)-DEIA-LiPA(25) between the self-sample and the physician-taken sample was 85.8% (kappa value, 0.715; 95% confidence interval [CI], 0.597 to 0.843; P = 1.000). The overall agreement for hrHPV detection using GP5+/6+-LQ between the self-sample and the physician-taken sample was 86.6% (kappa value, 0.725; 95% CI, 0.607 to 0.843; P = 0.815). Ninety-eight percent of the women rated their experience as good to excellent. Moreover, 95% of women preferred self-sampling to physician sampling. Self-sampling using the dry Evalyn Brush system is as good as a physician-taken sample for hrHPV detection and is highly acceptable to women. To validate this self-sampling device for clinical use, a large screening cohort should be studied.
authors.affiliation: DDL Diagnostic Laboratory, Rijswijk, Netherlands.
authors.forename: Romy
authors.initials: R
authors.lastname: van Baars
authors.forename: Remko P
authors.initials: RP
authors.lastname: Bosgraaf
authors.forename: Bram W A
authors.initials: BW
authors.lastname: ter Harmsel
authors.forename: Willem J G
authors.initials: WJ
authors.lastname: Melchers
authors.forename: Wim G V
authors.initials: WG
authors.lastname: Quint
authors.forename: Ruud L M
authors.initials: RL
authors.lastname: Bekkers
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000821:virology; D019411:Clinical Laboratory Techniques / Q000379:methods*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D010342:Patient Acceptance of Health Care; D016133:Polymerase Chain Reaction / Q000379:methods; D012646:Self Administration / Q000379:methods*; D013048:Specimen Handling / Q000379:methods*; D014773:Virology / Q000379:methods*; D055815:Young Adult