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- Title
Effectiveness of novel, lower cost molecular human papillomavirus-based tests for cervical cancer screening in rural china.
- Authors
Valdez, Melissa; Jeronimo, Jose; Bansil, Pooja; Qiao, You‐Lin; Zhao, Fang‐Hui; Chen, Wen; Zhang, Xun; Kang, Le‐Ni; Paul, Proma; Bai, Ping; Peck, Roger; Li, Jing; Chen, Feng; Stoler, Mark H.; Castle, Philip E.
- Abstract
This study examined the efficacy of the Onco E6™ 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 Onco E6™ test. The Onco E6™ 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.
- Publication
International Journal of Cancer, 2016, Vol 138, Issue 6, p1453
- ISSN
0020-7136
- Publication type
Article
- DOI
10.1002/ijc.29877