title: Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections.
abstract: Two devices for vaginal self-sampling of dry cell material (Evalyn Brush, Rovers Medical Devices; Qvintip, Aprovix) were compared using the Abbott RealTime High Risk HPV test.
  
  
  
  Both self-sampling devices (change of order with every patient) including instructions for use and a questionnaire were handed to 146 patients in a colposcopy clinic prior to scheduled colposcopies with collection of cervical reference specimens by gynaecologists using a broom-like device. Matched self-collected and physician collected specimens were transferred to ThinPrep medium and tested for the presence of hr-HPV. Biopsies were taken if indicated by colposcopy.
  
  
  
  Evaluation of 136 patients with complete data (136/146; 93.2%) showed high agreement of overall hr-HPV detection rates between self-collected and clinician-collected specimens (Evalyn: 91.2% [kappa 0.822]; Qvintip: 89.0% [kappa 0.779]). Colposcopy and histological evaluation revealed 55 women without cervical intraepithelial neoplasia (CIN), 32 CIN1, 34 CIN2, 14 CIN3 and one adenocarcinoma in situ. Hr-HPV testing detected all CIN3+ cases on the clinician-taken or Evalyn self-samples (14/14) and 93% of them on the Qvintip samples (13/14). There was no significant difference regarding the sensitivity for CIN2+ or CIN3+ and specificity of hr-HPV testing on self- vs. clinician samples and on Evalyn vs. Qvintip. Based on signal intensities of β-globin, the observed DNA concentration with Evalyn samples (mean CN: 22.0; 95%-CI: 21.5-22.6) was found to be significantly higher compared to that of Qvintip samples (mean CN: 23.8; 95%-CI 23.2-24.4), regardless of the order of self-sampling (p<0.0001). Most women considered self-sampling easy and comfortable. Qvintip was considered easier than the Evalyn Brush to understand (p<0.001) and to use (p=0.002).
  
  
  
  This study confirms that hr-HPV testing with a clinically validated PCR-based HPV assay is as accurate on self-samples as on clinician-samples without significant difference between both self-sampling devices.
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Electronic address: Jentschke.Matthias@mh-hannover.de.
authors.forename: M
authors.initials: M
authors.lastname: Jentschke
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany; Department of Gynaecology and Obstetrics, Tongji Hospital, Tongji University, Xin Cun Road 389#, 200065 Shanghai, China.
authors.forename: K
authors.initials: K
authors.lastname: Chen
authors.affiliation: Scientific Institute of Public Health (WIV-ISP), 14, Rue Juliette Wytsman, 1050 Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Arbyn
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Hertel
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Noskowicz
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Soergel
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Hillemanns
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D055088:Early Detection of Cancer / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D010865:Pilot Projects; D016353:Self-Examination / Q000295:instrumentation* / Q000379:methods; D013048:Specimen Handling / Q000295:instrumentation* / Q000379:methods; D011795:Surveys and Questionnaires; D014621:Vagina / Q000821:virology*; D055815:Young Adult
keywords: Cervical cancer screening; Human papillomavirus; Self-sampling