Lower cost strategies for triage of human papillomavirus DNA-positive women

You Lin Qiao, Jose Jeronimo, Fang Hui Zhao, 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

Research output: Contribution to journalArticle

56 Scopus citations

Abstract

Using human papillomavirus (HPV) testing for cervical cancer screening in lower-resource settings (LRS) will result in a significant number of screen-positive women. This analysis compares different triage strategies for detecting cervical precancer and cancer among HPV-positive women in LRS. This was a population-based study of women aged 25-65 years living in China (n = 7,541). Each woman provided a self-collected and two clinician-collected specimens. The self-collected and one clinician-collected specimen were tested by two HPV DNA tests - careHPV™ and Hybrid Capture 2; the other clinician-collected specimen was tested for HPV16/18/45 E6 protein. CareHPV™-positive specimens were tested for HPV16/18/45 DNA. HPV DNA-positive women underwent visual inspection with acetic acid (VIA) and then colposcopic evaluation with biopsies. The performance for detection of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+) among HPV DNA-positive women was assessed for different triage strategies: HPV16/18/45 E6 or DNA detection, VIA, colposcopic impression, or higher signal strength (≥10 relative light units/positive control [rlu/pc]). The percent triage positive ranges were 14.8-17.4% for VIA, 17.8-20.9% for an abnormal colposcopic impression; 7.9-10.5% for HPV16/18/45 E6; 23.4-28.4% for HPV16/18/45 DNA; and 48.0-62.6% for higher signal strength (≥10 rlu/pc), depending on the HPV test/specimen combination. The positivity for all triage tests increased with severity of diagnosis. HPV16/18/45 DNA detection was approximately 70% sensitive and had positive predictive values (PPV) of approximately 25% for CIN3+. HPV16/18/45 E6 detection was approximately 50% sensitive with a PPV of nearly 50% for CIN3+. Different triage strategies for HPV DNA-positive women provide important tradeoffs in colposcopy or treatment referral percentages and sensitivity for prevalent CIN3+. What's new? The careHPV™ test is a novel technology for primary cervical cancer screening of women from lower-resource settings. However, triage strategies are needed to identify which HPV-positive women are at highest risk of cervical precancer and cancer. Here, multiple viable and affordable strategies to manage HPV-positive women depending on local requirements and resources are identified, based on evaluation of the performance of different triage strategies for developing countries. The different strategies for women who test positive for HPV DNA provide important tradeoffs in colposcopy or treatment referral percentages and sensitivity for cervical intraepithelial neoplasia grade 3 or cancer (CIN3+).

Original languageEnglish (US)
Pages (from-to)2891-2901
Number of pages11
JournalInternational Journal of Cancer
Volume134
Issue number12
DOIs
StatePublished - Jun 15 2014

Keywords

  • E6
  • HPV
  • careHPV
  • cervical cancer
  • developing countries
  • triage

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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  • Cite this

    Qiao, Y. L., Jeronimo, J., Zhao, F. H., 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. (2014). Lower cost strategies for triage of human papillomavirus DNA-positive women. International Journal of Cancer, 134(12), 2891-2901. https://doi.org/10.1002/ijc.28616