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A rapid HPV typing assay to support global cervical cancer screening and risk-based management: A cross-sectional study

  1. Author:
    Inturrisi, Federica [ORCID]
    de Sanjosé, Silvia
    Desai, Kanan T
    Dagnall,Casey
    Egemen, Didem
    Befano, Brian
    Rodriguez, Ana Cecilia
    Jeronimo, Jose A
    Zuna, Rosemary E
    Hoffman, Amanda
    Farhat Nozzari, Sepideh
    Walker, Joan L
    Perkins, Rebecca B
    Wentzensen, Nicolas [ORCID]
    Palefsky, Joel M
    Schiffman, Mark

  2. Author Address

    Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland, USA., ISGlobal, Barcelona, Spain., Cancer Genomics Research Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research Inc., Frederick, Maryland, USA., Information Management Services Inc., Calverton, Maryland, USA., Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington, USA., Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA., Department of Medicine, University of California San Francisco, San Francisco, California, USA., Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA., Department of Obstetrics and Gynecology, Boston Medical Center/Boston University School of Medicine, Boston, Maryland, USA.,
    1. Year: 2023
    2. Date: Sep 29
    3. Epub Date: 2023 09 29
  2. Journal: International Journal of Cancer
  4. Type of Article: Article
  1. Abstract:

    The World Health Organization recommends human papillomavirus (HPV) testing for cervical screening. Extended genotyping can identify the highest-risk HPV-positive women. An inexpensive, rapid, mobile isothermal amplification assay (ScreenFire HPV RS test) was recently redesigned to yield four channels ordered by cancer risk (ie, hierarchical approach): HPV16, HPV18/45, HPV31/33/35/52/58 and HPV39/51/56/59/68. Stored specimens from 2076 women (mean age 30.9) enrolled in a colposcopy clinic, with high HPV prevalence, were tested with ScreenFire. We calculated hierarchical channel positivity and non-hierarchical channel and type positivity, according to histologic diagnosis (256 cancer, 350 cervical intraepithelial neoplasia [CIN]3, 409 CIN2, 1020?< ?CIN2) and known virologic reference results (Linear Array and TypeSeq). Additionally, we analyzed ScreenFire time-to-positive up to 60?min by channel and histology. Overall clinical sensitivity for CIN3+ was 94.7% (95% confidence interval 92.6-96.4), similar to Linear Array (92.3, 89.7-94.3) and TypeSeq (96.0, 93.9-97.6). Sensitivity was high for all types and channels. The hierarchical approach was well in line with HPV typing and histologic diagnosis, prioritizing higher risk women having HPV16 and precancer. For HPV16, time-to-positive was shorter in women with precancer. ScreenFire showed excellent agreement with research reference typing tests and detection of CIN2+. Risk-based type results could help guide clinical management of HPV-positive women. Time-to-positive combined with genotyping might be useful. ScreenFire is rapid, mobile, relatively inexpensive and designed for implementation of HPV-based screening and management, including in lower-resource settings. Further validation in screening by self-sampling and practical effectiveness merit evaluation. © 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.

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  2. DOI: 10.1002/ijc.34698
  3. PMID: 37772799

Library Notes

  1. Fiscal Year: FY2023-2024
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