Assessment of a new lower-cost real-time PCR assay for detection of high-risk human papillomavirus: Useful for cervical screening in limited-resource settings?

Joel Fokom Domgue, Mark Schiffman, Nicolas H. Wentzensen, Julia C. Gage, Philip E. Castle, Tina R. Raine-Bennett, Barbara Fetterman, Thomas Lorey, Nancy E. Poitras, Brian Befano, Yi Xie, Lais S. Miachon, Michael Dean

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Inexpensive and easy-to-perform human papillomavirus (HPV) tests are needed for primary cervical cancer screening in lower-resource regions. In a convenience sample of 516 residual exfoliative cervical specimens from the Kaiser Permanente Northern California and U.S. National Cancer Institute Persistence and Progression Study, we assessed the agreement and clinical performance of a simple, inexpensive real-time PCR assay for the detection of 13 carcinogenic HPV types (the H13 assay; Hybribio, Hong Kong) that is marketed in limited-resource settings compared to previous testing by the Hybrid Capture 2 assay (HC2; Qiagen, Germantown, MD) and the Onclarity assay (BD Diagnostics, Sparks, MD). The test set was chosen to include many HPV-positive specimens. The reference standard was a combination of HC2 and Onclarity results for HPV detection and histologic diagnosis of controls (less than cervical intraepithelial neoplasia grade 2 [CIN2]) or cases (cervical intraepithelial neoplasia grade 2 or higher [CIN2]) for disease status. In this enriched convenience sample, H13 tested positive for 94.4% of the 108 HC2-and Onclaritypositive CIN2 specimens and negative for 88.2% of the 51 HC2-and Onclaritynegative CIN2 specimens. H13 positivity was significantly lower than that of HC2 among women with CIN2 (89.9% versus 98.7%, respectively) (P 0.001) and CIN2 (53.5% versus 72.4%, respectively) (P 0.001). In conclusion, H13 corresponds well to the combination of HC2 and Onclarity and has good clinical accuracy compared to histologic diagnosis, with less cross-reactivity with untargeted HPV types than HC2. H13 is a lower-cost HPV DNA test that might be useful for primary screening in limited-resource settings.

Original languageEnglish (US)
Pages (from-to)2348-2355
Number of pages8
JournalJournal of Clinical Microbiology
Volume55
Issue number8
DOIs
StatePublished - Aug 1 2017

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Keywords

  • Accuracy
  • Cervical cancer
  • High-risk HPV
  • HPV
  • HPV testing
  • Human papillomavirus
  • Limited resource settings
  • PCR-based assay
  • Prevention
  • Screening
  • Validation

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Domgue, J. F., Schiffman, M., Wentzensen, N. H., Gage, J. C., Castle, P. E., Raine-Bennett, T. R., Fetterman, B., Lorey, T., Poitras, N. E., Befano, B., Xie, Y., Miachon, L. S., & Dean, M. (2017). Assessment of a new lower-cost real-time PCR assay for detection of high-risk human papillomavirus: Useful for cervical screening in limited-resource settings? Journal of Clinical Microbiology, 55(8), 2348-2355. https://doi.org/10.1128/JCM.00492-17