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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Yang, HP; Walmer, DK; Merisier, D; Gage, JC; Bell, L; Rangwala, S; Shrestha, N; Kobayashi, L; Eder, PS; Castle, PE

Published Date

  • September 2011

Published In

Volume / Issue

  • 176 / 1-2

Start / End Page

  • 112 - 114

PubMed ID

  • 21640138

Pubmed Central ID

  • PMC3155880

Electronic International Standard Serial Number (EISSN)

  • 1879-0984

International Standard Serial Number (ISSN)

  • 0166-0934

Digital Object Identifier (DOI)

  • 10.1016/j.jviromet.2011.05.024


  • eng