title: Comparison of urine specimen collection times and testing fractions for the detection of high-risk human papillomavirus and high-grade cervical precancer.
abstract: BACKGROUND
  Urine testing for high-risk human papillomavirus (HR-HPV) detection could provide a non-invasive, simple method for cervical cancer screening.
  
  
  OBJECTIVE
  We examined whether HR-HPV detection is affected by urine collection time, portion of urine stream, or urine fraction tested, and assessed the performance of HR-HPV testing in urine for detection of cervical intraepithelial neoplasia grade II or worse (CIN2+).
  
  
  METHODS
  A total of 37 female colposcopy clinic attendees, ≥ 30 years, provided three urine samples: "first void" urine collected at home, and "initial stream" and "mid-stream" urine samples collected at the clinic later in the day. Self- and physician-collected brush specimens were obtained at the same clinic visit. Colposcopy was performed and directed biopsies obtained if clinically indicated. For each urine sample, HR-HPV DNA testing was conducted for unfractionated, pellet, and supernatant fractions using the Trovagene test. HR-HPV mRNA testing was performed on brush specimens using the Aptima HPV assay.
  
  
  RESULTS
  HR-HPV prevalence was similar in unfractionated and pellet fractions of all urine samples. For supernatant urine fractions, HR-HPV prevalence appeared lower in mid-stream urine (56.8%[40.8-72.7%]) than in initial stream urine (75.7%[61.9-89.5%]). Sensitivity of CIN2+ detection was identical for initial stream urine and physician-collected cervical specimen (89.9%[95%CI=62.7-99.6%]), and similar to self-collected vaginal specimen (79.1%[48.1-96.6%]).
  
  
  CONCLUSIONS
  This is among the first studies to compare methodologies for collection and processing of urine for HR-HPV detection. HR-HPV prevalence was similar in first void and initial stream urine, and was highly sensitive for CIN2+ detection. Additional research in a larger and general screening population is needed.
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC, USA.
authors.forename: V
authors.initials: V
authors.lastname: Senkomago
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC, USA.
authors.forename: A C
authors.initials: AC
authors.lastname: Des Marais
authors.affiliation: Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
authors.forename: L
authors.initials: L
authors.lastname: Rahangdale
authors.affiliation: Trovagene Inc., San Diego, CA, USA.
authors.forename: C R T
authors.initials: CR
authors.lastname: Vibat
authors.affiliation: Trovagene Inc., San Diego, CA, USA.
authors.forename: M G
authors.initials: MG
authors.lastname: Erlander
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA. Electronic address: JenniferS@unc.edu.
authors.forename: J S
authors.initials: JS
authors.lastname: Smith
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000302:isolation & purification; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D010865:Pilot Projects; D011230:Precancerous Conditions / Q000175:diagnosis* / Q000821:virology; D012333:RNA, Messenger / Q000302:isolation & purification; D012367:RNA, Viral / Q000302:isolation & purification; D012680:Sensitivity and Specificity; D014556:Urine / Q000821:virology*; D059349:Urine Specimen Collection / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral; D012333:RNA, Messenger; D012367:RNA, Viral
keywords: Cervical cancer screening; Human papillomavirus; Urine