A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test
Copyright policy )A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test
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.
- American Society for Clinical Pathology United States
- National Cancer Institute United States
- Durham University United Kingdom
- Division of Cancer Epidemiology and Genetics United States
- Duke University United States
Human papillomavirus 16, Human papillomavirus 18, Papillomavirus Infections, Uterine Cervical Neoplasms, Pilot Projects, Cervix Uteri, Uterine Cervical Dysplasia, Polymerase Chain Reaction, Colposcopy, DNA, Viral, Humans, Female
Human papillomavirus 16, Human papillomavirus 18, Papillomavirus Infections, Uterine Cervical Neoplasms, Pilot Projects, Cervix Uteri, Uterine Cervical Dysplasia, Polymerase Chain Reaction, Colposcopy, DNA, Viral, Humans, Female
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