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

作者：Yang Hannah P^*; Walmer David K; Merisier Delson; Gage Julia C; Bell Laura; Rangwala Sameera; Shrestha Niwashin; Kobayashi Lori; Eder Paul S; Castle Philip E

来源：Journal of Virological Methods, 2011, 176(1-2): 112-114.

DOI：10.1016/j.jviromet.2011.05.024

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

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. Published by Elsevier B.V.

• 出版日期2011-9