title: A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test.
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.
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, Bethesda, MD 20892-7234, USA. yanghan@mail.nih.gov
authors.forename: Hannah P
authors.initials: HP
authors.lastname: Yang
authors.forename: David K
authors.initials: DK
authors.lastname: Walmer
authors.forename: Delson
authors.initials: D
authors.lastname: Merisier
authors.forename: Julia C
authors.initials: JC
authors.lastname: Gage
authors.forename: Laura
authors.initials: L
authors.lastname: Bell
authors.forename: Sameera
authors.initials: S
authors.lastname: Rangwala
authors.forename: Niwashin
authors.initials: N
authors.lastname: Shrestha
authors.forename: Lori
authors.initials: L
authors.lastname: Kobayashi
authors.forename: Paul S
authors.initials: PS
authors.lastname: Eder
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
mesh_terms: D002584:Cervix Uteri / Q000821:virology; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D052162:Human papillomavirus 16 / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000145:classification* / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D030361:Papillomavirus Infections / Q000821:virology*; D010865:Pilot Projects; D016133:Polymerase Chain Reaction / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D002578:Uterine Cervical Dysplasia / Q000821:virology*
chemical_list: D004279:DNA, Viral