title: Effectiveness of novel, lower cost molecular human papillomavirus-based tests for cervical cancer screening in rural china.
abstract: This study examined the efficacy of the OncoE6™ Cervical Test, careHPV™ and visual inspection with acetic acid (VIA) in identifying women at risk for cervical cancer and their capability to detect incident cervical precancer and cancer at 1-year follow-up. In a population of 7,543 women living in rural China, women provided a self-collected and two clinician-collected specimens and underwent VIA. All screen positive women for any of the tests, a ∼ 10% random sample of test-negative women that underwent colposcopy at baseline, and an additional ∼ 10% random sample of test-negative women who did not undergo colposcopy at baseline (n = 3,290) were recruited. 2,904 women were rescreened 1 year later using the same tests, colposcopic referral criteria, and procedures. Sensitivities of baseline tests to detect 1-year cumulative cervical intraepithelial neoplasia Grade 3 or cancer (CIN3+) were 96.5% and 81.6% for careHPV™ on clinician-collected and self-collected specimens, respectively, and 54.4% for OncoE6™ test. The OncoE6™ test was very specific (99.1%) and had the greatest positive predictive value (PPV; 47.7%) for CIN3+. Baseline and 1-year follow-up cervical specimens testing HPV DNA positive was sensitive (88.0%) but poorly predictive (5.5-6.0%) of incident CIN2+, whereas testing repeat HPV16, 18 and 45 E6 positive identified only 24.0% of incident CIN2+ but had a predictive value of 33.3%. This study highlights the different utility of HPV DNA and E6 tests, the former as a screening and the latter as a diagnostic test, for detection of cervical precancer and cancer.
authors.affiliation: PATH, Seattle, WA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Valdez
authors.affiliation: PATH, Seattle, WA.
authors.forename: Jose
authors.initials: J
authors.lastname: Jeronimo
authors.affiliation: PATH, Seattle, WA.
authors.forename: Pooja
authors.initials: P
authors.lastname: Bansil
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Qiao
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Le-Ni
authors.initials: LN
authors.lastname: Kang
authors.affiliation: PATH, Seattle, WA.
authors.forename: Proma
authors.initials: P
authors.lastname: Paul
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Bai
authors.affiliation: PATH, Seattle, WA.
authors.forename: Roger
authors.initials: R
authors.lastname: Peck
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Chen
authors.affiliation: Department of Pathology, University of Virginia, Charlottesville, VA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: Global Coalition against Cervical Cancer, Chestertown, MD.|Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D002681:China / Q000453:epidemiology; D003362:Cost-Benefit Analysis; D055088:Early Detection of Cancer / Q000191:economics* / Q000379:methods*; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000191:economics / Q000379:methods; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics*; D030361:Papillomavirus Infections / Q000150:complications* / Q000821:virology*; D011159:Population Surveillance; D015203:Reproducibility of Results; D012424:Rural Population; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology*
keywords: E6; HPV; cervical cancer screening; cervical intraepithelial neoplasia