A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test

Hannah P. Yang, David K. Walmer, Delson Merisier, Julia C. Gage, Laura Bell, Sameera Rangwala, Niwashin Shrestha, Lori Kobayashi, Paul S. Eder, Philip E. Castle

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

The analytic performance of a low-cost, research-stage DNA test for the most carcinogenic human papillomavirus (HPV) genotypes (HPV16, HPV18, and HPV45) in aggregate was evaluated among carcinogenic HPV-positive women, which might be used to decide who needs immediate colposcopy in low-resource settings (" triage test"). We found that HPV16/18/45 test agreed well with two DNA tests, a GP5+/6+ genotyping assay (Kappa = 0.77) and a quantitative PCR assay (at a cutpoint of 5000 viral copies) (Kappa = 0.87). DNA sequencing on a subset of 16 HPV16/18/45 positive and 16 HPV16/18/45 negative verified the analytic specificity of the research test. It is concluded that the HPV16/18/45 assay is a promising triage test with a minimum detection of approximately 5000 viral copies, the clinically relevant threshold.

Original languageEnglish (US)
Pages (from-to)112-114
Number of pages3
JournalJournal of Virological Methods
Volume176
Issue number1-2
DOIs
StatePublished - Sep 2011

Keywords

  • Cervical cancer
  • HPV genotypes
  • HPV test
  • Human papillomavirus (HPV)

ASJC Scopus subject areas

  • Virology

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