title: Long-Term Follow-up of HPV Infection Using Urine and Cervical Quantitative HPV DNA Testing.
abstract: The link between infection with high-risk human papillomavirus (hrHPV) and cervical cancer has been clearly demonstrated. Virological end-points showing the absence of persistent HPV infection are now accepted as a way of monitoring the impact of prophylactic vaccination programs and therapeutic vaccine trials. This study investigated the use of urine samples, which can be collected by self-sampling at home, instead of cervical samples for follow-up of an HPV intervention trial. Eighteen initially HPV DNA-positive women participating in an HPV therapeutic vaccine trial were monitored during a three-year follow-up period. A total of 172 urine samples and 85 cervical samples were collected. We obtained a paired urine sample for each of the 85 cervical samples by recovering urine samples from six monthly gynaecological examinations. We performed a small pilot study in which the participating women used a urine collection device at home and returned their urine sample to the laboratory by mail. All samples were analyzed using quantitative real-time HPV DNA PCR. A good association (κ value of 0.65) was found between the presence of HPV DNA in urine and a subsequent cervical sample. Comparisons of the number of HPV DNA copies in urine and paired cervical samples revealed a significant Spearman rho of 0.676. This correlation was superior in women with severe lesions. The HPV DNA results of the small pilot study based on self-collected urine samples at home are consistent with previous and subsequent urine and/or cervical results. We demonstrated that urine sampling may be a valid alternative to cervical samples for the follow-up of HPV intervention trials or programs. The potential clinical value of urine viral load monitoring should be further investigated.
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine &amp; Infectious Disease Institute, University of Antwerp, 2610 Wilrijk, Belgium. alex.vorsters@uantwerpen.be.
authors.forename: Alex
authors.initials: A
authors.lastname: Vorsters
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine &amp; Infectious Disease Institute, University of Antwerp, 2610 Wilrijk, Belgium. severien.vankeer@uantwerpen.be.
authors.forename: Severien
authors.initials: S
authors.lastname: Van Keer
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine &amp; Infectious Disease Institute, University of Antwerp, 2610 Wilrijk, Belgium. samantha.biesmans@uantwerpen.be.
authors.forename: Samantha
authors.initials: S
authors.lastname: Biesmans
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine &amp; Infectious Disease Institute, University of Antwerp, 2610 Wilrijk, Belgium. annick.hens@uantwerpen.be.
authors.forename: Annick
authors.initials: A
authors.lastname: Hens
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine &amp; Infectious Disease Institute, University of Antwerp, 2610 Wilrijk, Belgium. ilse.decoster@uantwerpen.be.
authors.forename: Ilse
authors.initials: I
authors.lastname: De Coster
authors.affiliation: Laboratory of Medical Microbiology, Vaccine &amp; Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Wilrijk, Belgium. herman.goossens@uantwerpen.be.|Clinical Microbiology, Antwerp University Hospital, 2650 Edegem, Belgium. herman.goossens@uantwerpen.be.
authors.forename: Herman
authors.initials: H
authors.lastname: Goossens
authors.affiliation: Laboratory of Medical Microbiology, Vaccine &amp; Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, 2610 Wilrijk, Belgium. greet.ieven@uza.be.|Clinical Microbiology, Antwerp University Hospital, 2650 Edegem, Belgium. greet.ieven@uza.be.
authors.forename: Margareta
authors.initials: M
authors.lastname: Ieven
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine &amp; Infectious Disease Institute, University of Antwerp, 2610 Wilrijk, Belgium. pierre.vandamme@uantwerpen.be.
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
mesh_terms: D002584:Cervix Uteri / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis / Q000652:urine; D005260:Female; D005500:Follow-Up Studies; D061809:Human Papillomavirus DNA Tests / Q000379:methods*; D006801:Humans; D008137:Longitudinal Studies; D027383:Papillomaviridae / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis*; D010865:Pilot Projects; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D012680:Sensitivity and Specificity; D014556:Urine / Q000821:virology*; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D019562:Viral Load
chemical_list: D004279:DNA, Viral
keywords: HPV DNA; HPV testing; self-sampling; urine; vaccination