title: Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population.
abstract: OBJECTIVE
  To evaluate the analytical and clinical effectiveness of cervicovaginal self-sampling with a dry sampling device (Evalyn Brush) for high-risk human papillomavirus (hr-HPV) testing and detection of cervical disease.
  
  
  METHODS
  The study population consisted of 101 patients from a large gynecological outpatient clinic in Shanghai referred for abnormal cervical screening results and 101 women without cervical lesions. Self-samples obtained in the clinic and physician-collected cervical specimens (reference) were stored at -20 °C for 16-18 weeks and then transferred to 20 ml of ThinPrep medium and tested for hr-HPV using a multiplex real time polymerase chain reaction assay. All women had a colposcopic examination with a Pap smear and directed or random biopsies.
  
  
  RESULTS
  High risk-HPV was detected in 92 patients (45.5%) with the self-collected cervicovaginal specimens and in 93 (46.0%) with the physician-collected cervical specimens, resulting in an agreement of 97.5% and a Kappa of 0.95 (95% confidence interval 0.91-0.99). Among all of the included women, 46 (22.8%) had cervical intraepithelial neoplasia grade 3 or worse (cervical intraepithelial neoplasia 3+). Hr-HPV was found in 43 of these patients (93.5%) with self-sampling and in 44 (95.7%) with the physician-collected specimens.
  
  
  CONCLUSIONS
  Self-collected dry cervicovaginal samples transferred to ThinPrep medium and tested for hr-HPV using a clinically validated polymerase chain reaction assay showed very good agreement with physician-collected cervical specimens and a very high hr-HPV positivity rate for cervical intraepithelial neoplasia 3 +.
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany.|Department of Gynaecology and Obstetrics, Tongji Hospital, Tongji University, Shanghai, China.
authors.forename: KeWei
authors.initials: K
authors.lastname: Chen
authors.affiliation: Department of Gynaecology and Obstetrics, Tongji Hospital, Tongji University, Shanghai, China.
authors.forename: YiQin
authors.initials: Y
authors.lastname: Ouyang
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Hillemanns
authors.affiliation: Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Jentschke
mesh_terms: D000328:Adult; D000368:Aged; D002681:China; D015344:DNA Probes, HPV; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000235:genetics; D014505:Urban Population; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D055815:Young Adult
chemical_list: D015344:DNA Probes, HPV
keywords: cervical cancer screening; cervical dysplasia; human papillomavirus; self-sampling