title: Pooled analysis of a self-sampling HPV DNA Test as a cervical cancer primary screening method.
abstract: BACKGROUND
  Worldwide, one-seventh of cervical cancers occur in China, which lacks a national screening program. By evaluating the diagnostic accuracy of self-collected cervicovaginal specimens tested for human papillomavirus (HPV) DNA (Self-HPV testing) in China, we sought to determine whether Self-HPV testing may serve as a primary cervical cancer screening method in low-resource settings.
  
  
  METHODS
  We compiled individual patient data from five population-based cervical cancer-screening studies in China. Participants (n = 13 140) received Self-HPV testing, physician-collected cervical specimens for HPV testing (Physician-HPV testing), liquid-based cytology (LBC), and visual inspection with acetic acid (VIA). Screen-positive women underwent colposcopy and confirmatory biopsy. We analyzed the accuracies of pooled Self-HPV testing, Physician-HPV testing, VIA, and LBC to detect biopsy-confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) and CIN3+. All statistical tests were two-sided.
  
  
  RESULTS
  Of 13 004 women included in the analysis, 507 (3.9%) were diagnosed as CIN2+, 273 (2.1%) as CIN3+, and 37 (0.3%) with cervical cancer. Self-HPV testing had 86.2% sensitivity and 80.7% specificity for detecting CIN2+ and 86.1% sensitivity and 79.5% specificity for detecting CIN3+. VIA had statistically significantly lower sensitivity for detecting CIN2+ (50.3%) and CIN3+ (55.7%) and higher specificity for detecting CIN2+ (87.4%) and CIN3+ (86.9%) (all P values < .001) than Self-HPV testing, LBC had lower sensitivity for detecting CIN2+ (80.7%, P = .015), similar sensitivity for detecting CIN3+ (89.0%, P = .341), and higher specificity for detecting CIN2+ (94.0%, P < .001) and CIN3+ (92.8%, P < .001) than Self-HPV testing. Physician-HPV testing was more sensitive for detecting CIN2+ (97.0%) and CIN3+ (97.8%) but similarly specific for detecting CIN2+ (82.7%) and CIN3+ (81.3%) (all P values <.001) than Self-HPV testing.
  
  
  CONCLUSIONS
  The sensitivity of Self-HPV testing compared favorably with that of LBC and was superior to the sensitivity of VIA. Self-HPV testing may complement current screening programs by increasing population coverage in settings that do not have easy access to comprehensive cytology-based screening.
authors.affiliation: Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.forename: Adam K
authors.initials: AK
authors.lastname: Lewkowitz
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.forename: Margaret J
authors.initials: MJ
authors.lastname: Lin
authors.forename: Shang-Ying
authors.initials: SY
authors.lastname: Hu
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.forename: Qin-Jing
authors.initials: QJ
authors.lastname: Pan
authors.forename: Jun-Fei
authors.initials: JF
authors.lastname: Ma
authors.forename: Mayineur
authors.initials: M
authors.lastname: Niyazi
authors.forename: Chang-Qing
authors.initials: CQ
authors.lastname: Li
authors.forename: Shu-Min
authors.initials: SM
authors.lastname: Li
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Smith
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D001706:Biopsy; D002681:China; D003127:Colposcopy; D004279:DNA, Viral / Q000302:isolation & purification; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D060787:Neoplasm Grading; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology; D012372:ROC Curve; D012424:Rural Population; D016353:Self-Examination; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D014412:Tumor Virus Infections / Q000175:diagnosis / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000517:prevention & control / Q000821:virology*; D014626:Vaginal Smears / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology
chemical_list: D004279:DNA, Viral