title: Clinical evaluation of human papillomavirus detection by careHPV™ test on physician-samples and self-samples using the indicating FTA Elute® card.
abstract: OBJECTIVE
  To make the clinical evaluation of a solid-state human papillomavirus (HPV) sampling medium in combination with an economical HPV testing method (careHPV™) for cervical cancer screening.
  
  
  METHODS
  396 women aged 25-65 years were enrolled for cervical cancer screening, and four samples were collected. Two samples were collected by woman themselves, among which one was stored in DCM preservative solution (called "liquid sample") and the other was applied on the Whatman Indicating FTA Elute® card (FTA card). Another two samples were collected by physician and stored in DCM preservative solution and FTA card, respectively. All the samples were detected by careHPV™ test. All the women were administered a colposcopy examination, and biopsies were taken for pathological confirmation if necessary.
  
  
  RESULTS
  FTA card demonstrated a comparable sensitivity of detecting high grade Cervical Intraepithelial Neoplasia (CIN) with the liquid sample carrier for self and physician-sampling, but showed a higher specificity than that of liquid sample carrier for self-sampling (FTA vs Liquid: 79.0% vs 71.6%, p=0.02). Generally, the FTA card had a comparable accuracy with that of Liquid-based medium by different sampling operators, with an area under the curve of 0.807 for physician and FTA, 0.781 for physician and Liquid, 0.728 for self and FTA, and 0.733 for self and Liquid (p>0.05).
  
  
  CONCLUSIONS
  FTA card is a promising sample carrier for cervical cancer screening. With appropriate education programmes and further optimization of the experimental workflow, FTA card based self-collection in combination with centralized careHPV™ testing can help expand the coverage of cervical cancer screening in low-resource areas.
authors.affiliation: National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China E-mail : qiaoy@cicams.ac.cn.
authors.forename: Shao-Ming
authors.initials: SM
authors.lastname: Wang
authors.forename: Shang-Ying
authors.initials: SY
authors.lastname: Hu
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.forename: Yu-Qing
authors.initials: YQ
authors.lastname: Zhang
authors.forename: Xin-Ming
authors.initials: XM
authors.lastname: Ma
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
mesh_terms: D000328:Adult; D000368:Aged; D002681:China; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis*; D012648:Self Care / Q000379:methods*; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
chemical_list: D004279:DNA, Viral