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Obstetrics and gynaecology
Research
Cross-sectional study of HPV testing in self-sampled urine and comparison with matched vaginal and cervical samples in women attending colposcopy for the management of abnormal cervical screening
  1. Alex Sargent1,
  2. Samantha Fletcher2,
  3. Katarina Bray2,
  4. Henry C Kitchener2,
  5. Emma J Crosbie2,3
  1. 1 Clinical Virology Department, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK
  2. 2 Gynaecological Oncology Research Group, Division of Cancer Sciences, University of Manchester, Faculty of Biology, Medicine and Health, Manchester, UK
  3. 3 Department of Obstetrics and Gynaecology, St Mary’s Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
  1. Correspondence to Dr Emma J Crosbie; emma.crosbie{at}manchester.ac.uk

Abstract

Objectives Human papillomavirus (HPV) testing in cervical screening offers the potential for self-sampling to improve uptake among non-attenders. High-risk (HR) HPV detection in urine shows promise, but few studies have examined its sensitivity for cervical intraepithelial neoplasia (CIN2+) detection compared with standard cervical samples. The aims of this cross-sectional study were to optimise conditions for urine testing for HPV detection; to determine concordance for HR-HPV detection in matched urine, vaginal and cervical samples; to compare the sensitivity of HR-HPV testing for the detection of CIN2+ in matched samples; and to determine the acceptability of urine testing for cervical screening.

Design Cross-sectional study.

Setting Secondary care colposcopy clinic in North West England.

Participants Women aged 25 years of age or older, attending colposcopy clinic for management of abnormal cervical screening results or a suspicious-looking cervix. In total, 104 women took part in the study. Triple matched samples were available for 79 and 66 women using Abbott RealTime (ART) and Roche Cobas 4800 (RC), respectively.

Intervention Self-collected urine and vaginal samples and practitioner-obtained cervical samples were tested for HR-HPV by ART and RC assays, including comparison of neat and preservative-fixed urine. Colposcopic opinion was recorded and directed cervical biopsies taken if clinically indicated. The acceptability of self-testing was evaluated by questionnaire.

Primary outcome measure The sensitivity of urine to detect underlying CIN2+.

Secondary outcome measures The comparative sensitivity of vaginal and cervical samples to detect CIN2+; the acceptability of urine sampling.

Results Preservative-fixed, but not neat urine, showed good concordance with vaginal samples for the detection of HR-HPV. The sensitivity for detecting CIN2+ was 15/18 (83%) for urine and 16/18 (89%) for cervical and vaginal samples by ART, and 15/17 (88%) for all samples by RC. Urine-based testing was broadly acceptable to women.

Conclusions Urinary HR-HPV detection offers an alternative strategy of cervical screening. Larger studies to determine its clinical utility are warranted.

  • Urinary human papillomavirus (HPV) detection
  • cervical intraepithelial neoplasia (CIN)
  • cervical cancer screening
  • acceptability

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-025388

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    Footnotes

    • Twitter @DrEmmaCrosbie

    • Contributors AS performed the laboratory analyses, data interpretation and wrote the first draft of the manuscript. SF and KB recruited and sampled the study participants and contributed to data interpretation. HCK and EJC designed the study and contributed to data interpretation and manuscript preparation. All authors reviewed the final version of the manuscript.

    • Funding EJC is a National Institute for Health Research (NIHR) Clinician Scientist (NIHR-CS-012-009) and is supported by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007). This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests HCK is Chair of the Advisory Committee for Cervical Screening (PHE), but the views expressed in this manuscript are those of the author and not Public Health England.

    • Ethics approval The study was approved by the North West Research Ethics Committee (15/NW/0218) and all women gave written, informed consent to take part.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Data are available and will be shared upon reasonable request.

    • Patient consent for publication Not required.