title: HPV testing in first-void urine provides sensitivity for CIN2+ detection comparable with a smear taken by a clinician or a brush-based self-sample: cross-sectional data from a triage population.
abstract: OBJECTIVE
  To compare the sensitivity of high-risk human papillomavirus (hrHPV) and genotype detection in self-collected urine samples in the morning (U1), and later on (U2), brush-based self-samples (SS), and clinician-taken smears (CTS) for detecting cervical intraepithelial neoplasia grade 2+ (CIN2+) in a colposcopic referral population.
  
  
  METHODS
  Cross-sectional single-centre study.
  
  
  METHODS
  A colposcopy clinic in Spain.
  
  
  METHODS
  A cohort of 113 women referred for colposcopy after an abnormal Pap smear.
  
  
  METHODS
  Women undergoing colposcopy with biopsy for abnormal Pap smears were sent a device (Colli-Pee™, Novosanis, Wijnegem, Belgium) to collect U1 on the morning of colposcopy. U2, CTS, and SS (Evalyn brush™, Rovers Medical Devices B.V., Oss, the Netherlands) were also analysed. All samples were tested for HPV DNA using the analytically sensitive SPF10-DEIA-LiPA25 assay and the clinically validated GP5+/6+-EIA-LMNX.
  
  
  METHODS
  Histologically confirmed CIN2+ and hrHPV positivity for 14 high-risk HPV types.
  
  
  RESULTS
  Samples from 91 patients were analysed. All CIN3 cases (n = 6) tested positive for hrHPV in CTS, SS, U1, and U2 with both HPV assays. Sensitivity for CIN2+ with the SPF10 system was 100, 100, 95, and 100%, respectively. With the GP5+/6+ assay, sensitivity was 95% in all sample types. The sensitivities and specificities for both tests on each of the sample types did not significantly differ. There was 10-14% discordance on hrHPV genotype.
  
  
  CONCLUSIONS
  CIN2+ detection using HPV testing of U1 shows a sensitivity similar to that of CTS or brush-based SS, and is convenient. There was substantial to almost excellent agreement between all samples on genotype with both hrHPV assays. There was no advantage in testing U1 compared with U2 samples.
  
  
  CONCLUSIONS
  Similar CIN2+ sensitivity for HPV testing in first-void urine, physician-taken smear and brush-based self-sample.
authors.affiliation: DDL Diagnostic Laboratory, ER Rijswijk, the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Leeman
authors.affiliation: Faculty of Medicine-University 9 of Barcelona, Institute of Gynaecology, Obstetrics and Neonatology, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi I 8 Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Del Pino
authors.affiliation: DDL Diagnostic Laboratory, ER Rijswijk, the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Molijn
authors.affiliation: Faculty of Medicine-University 9 of Barcelona, Institute of Gynaecology, Obstetrics and Neonatology, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi I 8 Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Rodriguez
authors.affiliation: Faculty of Medicine-University 9 of Barcelona, Institute of Gynaecology, Obstetrics and Neonatology, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi I 8 Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Torné
authors.affiliation: DDL Diagnostic Laboratory, ER Rijswijk, the Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: de Koning
authors.affiliation: Department of Pathology, ISGLobal 11 (Institut de Salit Global de Barcelona)-Hospital Clínic, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Ordi
authors.affiliation: Department of Pathology, Erasmus Medical Centre, CA Rotterdam, the Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: van Kemenade
authors.affiliation: DDL Diagnostic Laboratory, ER Rijswijk, the Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Jenkins
authors.affiliation: DDL Diagnostic Laboratory, ER Rijswijk, the Netherlands.
authors.forename: W
authors.initials: W
authors.lastname: Quint
mesh_terms: D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000652:urine; D003127:Colposcopy; D003430:Cross-Sectional Studies; D004279:DNA, Viral / Q000652:urine*; D059026:Diagnostic Self Evaluation; D005260:Female; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000235:genetics / Q000652:urine; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000652:urine / Q000821:virology; D014626:Vaginal Smears / Q000379:methods*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology / Q000652:urine / Q000821:virology
chemical_list: D015415:Biomarkers; D004279:DNA, Viral
keywords: Cervical intraepithelial neoplasia; human papillomavirus; self-sampling; urine