An evaluation of novel, lower-cost molecular screening tests for human papillomavirus in rural China

Fang Hui Zhao, Jose Jeronimo, You Lin Qiao, Johannes Schweizer, Wen Chen, Melissa Valdez, Peter Lu, Xun Zhang, Le Ni Kang, Pooja Bansil, Proma Paul, Charles Mahoney, Marthe Berard-Bergery, Ping Bai, Roger Peck, Jing Li, Feng Chen, Mark H. Stoler, Philip E. Castle

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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.

Original languageEnglish (US)
Pages (from-to)938-948
Number of pages11
JournalCancer Prevention Research
Volume6
Issue number9
DOIs
StatePublished - Sep 1 2013

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Zhao, F. H., Jeronimo, J., Qiao, Y. L., Schweizer, J., Chen, W., Valdez, M., Lu, P., Zhang, X., Kang, L. N., Bansil, P., Paul, P., Mahoney, C., Berard-Bergery, M., Bai, P., Peck, R., Li, J., Chen, F., Stoler, M. H., & Castle, P. E. (2013). An evaluation of novel, lower-cost molecular screening tests for human papillomavirus in rural China. Cancer Prevention Research, 6(9), 938-948. https://doi.org/10.1158/1940-6207.CAPR-13-0091