title: An evaluation of novel, lower-cost molecular screening tests for human papillomavirus in rural China.
abstract: New, lower-cost tests that target high-risk human papillomavirus (HR-HPV) have been developed for cervical cancer screening in lower-resource settings but large, population-based screening studies are lacking. Women ages 25 to 65 years and living in rural China (n = 7,543) self-collected a cervicovaginal specimen, had 2 cervical specimens collected by a clinician, and underwent visual inspection after acetic acid (VIA). The self- and one clinician-collected specimens underwent HR-HPV DNA testing by careHPV (QIAGEN) and Hybrid Capture 2 (HC2; QIAGEN) and the other clinician-collected specimen was tested for HPV16, 18, and 45 E6 using OncoE6 (Arbor Vita Corporation). Women who screened positive for any test and a random sample of those negative on all tests underwent colposcopic evaluation. The percent test positive was 1.8% for HPV E6 oncoprotein, between 14% and 18% for HR-HPV DNA testing, and 7.3% for VIA. The sensitivity for cervical intraepithelial neoplasia grade 3 or more severe (CIN3(+); n = 99) was 53.5% for OncoE6, 97.0% for both careHPV and HC2 testing of the clinician-collected specimen, 83.8% for careHPV testing and 90.9% for HC2 testing of the self-collected specimen, and 50.5% for VIA. OncoE6 had the greatest positive predictive value (PPV), at 40.8% for CIN3(+), compared with the other tests, which had a PPV of less than 10%. OncoE6 tested 70.3% positive for HPV16, 18, or 45-positive CIN3(+) and tested negative for all HPV16-, 18-, or 45-negative CIN3(+) (P < 0.0001). HPV E6 oncoprotein detection is useful for identifying women who have cervical precancer and cancer.
authors.affiliation: 1Department of Epidemiology, Cancer Institute and Hospital, Chinese Academyof Medical Sciences and Peking Union Medical College, Beijing, PR China.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.forename: Jose
authors.initials: J
authors.lastname: Jeronimo
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
authors.forename: Johannes
authors.initials: J
authors.lastname: Schweizer
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.forename: Melissa
authors.initials: M
authors.lastname: Valdez
authors.forename: Peter
authors.initials: P
authors.lastname: Lu
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.forename: Le-Ni
authors.initials: LN
authors.lastname: Kang
authors.forename: Pooja
authors.initials: P
authors.lastname: Bansil
authors.forename: Proma
authors.initials: P
authors.lastname: Paul
authors.forename: Charles
authors.initials: C
authors.lastname: Mahoney
authors.forename: Marthe
authors.initials: M
authors.lastname: Berard-Bergery
authors.forename: Ping
authors.initials: P
authors.lastname: Bai
authors.forename: Roger
authors.initials: R
authors.lastname: Peck
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D000328:Adult; D000368:Aged; D002681:China; D004279:DNA, Viral / Q000235:genetics; D055088:Early Detection of Cancer / Q000191:economics*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D060787:Neoplasm Grading; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000191:economics* / Q000821:virology; D011379:Prognosis; D012372:ROC Curve; D012189:Retrospective Studies; D012424:Rural Population; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000191:economics* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000191:economics* / Q000821:virology
chemical_list: D004279:DNA, Viral