title: Evaluation of clinical performance of a novel urine-based HPV detection assay among women attending a colposcopy clinic.
abstract: BACKGROUND
  Human papillomavirus (HPV) testing in urine offers a convenient approach for cervical cancer screening but has previously suffered from limited clinical sensitivity.
  
  
  OBJECTIVE
  We evaluated clinical performance of the prototype Trovagene HPV test, a novel polymerase chain reaction assay that targets the E1 region of the HPV genome and detects and amplifies short fragments of cell-free HPV DNA in urine.
  
  
  METHODS
  We conducted a pilot study among 72 women referred to colposcopy following abnormal screening. Participants provided a urine sample prior to clinician-collected cervical sampling and colposcopically-directed punch biopsy. Trovagene HPV test results on urine samples were compared with cervical and urine testing by Linear Array HPV Genotyping Test (LA-HPV) for detection of histologically-confirmed cervical precancerous lesions.
  
  
  RESULTS
  There was high concordance between urine samples tested by the Trovagene HPV test and corresponding cervical (87.5%) and urine (81.9%) samples tested by LA-HPV. The Trovagene HPV test had high sensitivity (92.3% for detecting CIN2/3, and 100% for CIN3), comparable to LA-HPV testing on cervical samples (96.0% and 100%, respectively), and higher than LA-HPV testing on urine samples (80.8% and 90.0%, respectively). In this referral population, the specificity of the Trovagene urine HPV test was non-significantly lower (29% for CIN2/3 and 25% for CIN3) than corresponding estimates of LA-HPV testing on cervical (36% and 28%, respectively) and urine (42% and 38%, respectively) samples.
  
  
  CONCLUSIONS
  This pilot study suggests that the Trovagene HPV test has high sensitivity for urine-based detection of cervical precancer and merits evaluation in larger studies.
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States; Vanderbilt University, Nashville, TN, United States. Electronic address: vikrant.sahasrabuddhe@nih.gov.
authors.forename: Vikrant V
authors.initials: VV
authors.lastname: Sahasrabuddhe
authors.affiliation: Johns Hopkins School of Public Health, Baltimore, MD, United States. Electronic address: pgravitt@jhsph.edu.
authors.forename: Patti E
authors.initials: PE
authors.lastname: Gravitt
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: terry-dunn@ouhsc.edu.
authors.forename: S Terence
authors.initials: ST
authors.lastname: Dunn
authors.affiliation: UTC Labs, New Orleans, LA, United States. Electronic address: drobbins@renrx.com.
authors.forename: David
authors.initials: D
authors.lastname: Robbins
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: david-brown@ouhsc.edu.
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: richard-allen@ouhsc.edu.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Allen
authors.affiliation: Johns Hopkins School of Public Health, Baltimore, MD, United States. Electronic address: yeby@jhsph.edu.
authors.forename: Yolanda J
authors.initials: YJ
authors.lastname: Eby
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: katie-smith@ouhsc.edu.
authors.forename: Katie M
authors.initials: KM
authors.lastname: Smith
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: rosemary-zuna@ouhsc.edu.
authors.forename: Rosemary E
authors.initials: RE
authors.lastname: Zuna
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: roy-zhang@ouhsc.edu.
authors.forename: Roy R
authors.initials: RR
authors.lastname: Zhang
authors.affiliation: Tulsa Cancer Institute and the University of Oklahoma School of Community Medicine, Tulsa, OK, United States. Electronic address: michael.gold@tciok.org.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Gold
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States. Electronic address: schiffmm@exchange.nih.gov.
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: joan-walker@ouhsc.edu.
authors.forename: Joan L
authors.initials: JL
authors.lastname: Walker
authors.affiliation: Global Cancer Initiative, Chestertown, MD, United States. Electronic address: castle.philip@gmail.com.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Castle
authors.affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States. Electronic address: wentzenn@mail.nih.gov.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wentzensen
mesh_terms: D000328:Adult; D003127:Colposcopy; D004265:DNA Helicases / Q000032:analysis; D004279:DNA, Viral / Q000652:urine*; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D006801:Humans; D008403:Mass Screening; D009856:Oncogene Proteins, Viral / Q000032:analysis; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000652:urine*; D010865:Pilot Projects; D011230:Precancerous Conditions / Q000175:diagnosis* / Q000652:urine; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000517:prevention & control / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral; C093478:E1 protein, Human papillomavirus 16; D009856:Oncogene Proteins, Viral; D004265:DNA Helicases
keywords: Cervical cancer; Human papillomavirus; Screening; Urine