title: Performance and Diagnostic Accuracy of a Urine-Based Human Papillomavirus Assay in a Referral Population.
abstract: Background:Human papillomavirus (HPV) testing from clinician-collected cervical and self-collected cervico-vaginal samples is more sensitive for detecting CIN2+/CIN3+than cytology-based screening, stimulating interest in HPV testing from urine. The objective was to determine the performance of the Trovagene HPV test for the detection of CIN2+from urine and PreservCyt cervical samples.Methods:Women referred for colposcopy at St Mary's Hospital (London, United Kingdom), following abnormal cytology, were recruited to this diagnostic accuracy study by convenience sampling (September 2011 to April 2013). A total of 501 paired urine and cervical samples were collected. Primary outcomes were sensitivity for CIN2+/CIN3+and specificity for <CIN2; secondary outcomes were comparisons with other HPV tests and agreement/kappa values between urine and cervical samples.Results:Trovagene HPV test sensitivity and specificity from PreservCyt were similar to well-established tests [sensitivity for CIN3+(n= 145) 96.3% (95% confidence interval (CI), 89.6-99.2); CIN2+(n= 81) 94.5% (95% CI, 89.4-97.6); specificity for <CIN2 25.3% (95% CI, 20.8-30.1)]. Sensitivity from urine was slightly, but not significantly, lower [CIN3+91.4% (95% CI, 83.0-96.5),P= 0.3; CIN2+88.3% (95% CI, 81.9-93.0),P= 0.06]. Specificity for <CIN2 was similar: 24.7% (95% CI, 20.3-29.5),P= 0.9. A total of 403 Trovagene cervical and 396 urine HPV tests were positive. Overall agreement between paired samples was 82.6% (95% CI, 79.3-86.0).Conclusions:Trovagene HPV test's performance on PreservCyt cervical samples was comparable with established HPV tests. Sensitivity in urine, although slightly lower, may nevertheless be adequate for self-sampling. This referral population's higher HPV positivity rate affects specificity, warranting further studies in a screening population.Impact:This may prove useful for women not attending for cervical screening.Cancer Epidemiol Biomarkers Prev; 26(7); 1053-9. ©2017 AACR.
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom. j.cuzick@qmul.ac.uk.
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: Louise
authors.initials: L
authors.lastname: Cadman
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: Amar S
authors.initials: AS
authors.lastname: Ahmad
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: Linda
authors.initials: L
authors.lastname: Ho
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: George
authors.initials: G
authors.lastname: Terry
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: Michelle
authors.initials: M
authors.lastname: Kleeman
authors.affiliation: Imperial College Healthcare NHS Trust, St Mary's Hospital, London, United Kingdom.
authors.forename: Deirdre
authors.initials: D
authors.lastname: Lyons
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: Janet
authors.initials: J
authors.lastname: Austin
authors.affiliation: Department of Pathology, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.affiliation: Trovagene Inc., San Diego, California.
authors.forename: Cecile Rose T
authors.initials: CRT
authors.lastname: Vibat
authors.affiliation: Trovagene Inc., San Diego, California.
authors.forename: Janel
authors.initials: J
authors.lastname: Dockter
authors.affiliation: Trovagene Inc., San Diego, California.|Genomind Inc. King of Prussia, Pennsylvania.
authors.forename: David
authors.initials: D
authors.lastname: Robbins
authors.affiliation: Trovagene Inc., San Diego, California.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Billings
authors.affiliation: Trovagene Inc., San Diego, California.
authors.forename: Mark G
authors.initials: MG
authors.lastname: Erlander
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000473:pathology; D003127:Colposcopy; D004279:DNA, Viral / Q000302:isolation & purification; D055088:Early Detection of Cancer / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000473:pathology / Q000652:urine* / Q000821:virology; D011446:Prospective Studies; D012367:RNA, Viral / Q000302:isolation & purification; D012017:Referral and Consultation; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D006113:United Kingdom; D016482:Urinalysis / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000652:urine* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000652:urine* / Q000821:virology
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral