Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial

Jennifer C Davies; Alexandra Sargent; Elisabeth Pinggera; Suzanne Carter; Clare Gilham; Peter Sasieni; Emma J Crosbie

doi:10.1111/1471-0528.17831

Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial

BJOG. 2024 Apr 25. doi: 10.1111/1471-0528.17831. Online ahead of print.

Authors

Jennifer C Davies^{1

2}, Alexandra Sargent³, Elisabeth Pinggera¹, Suzanne Carter¹, Clare Gilham⁴, Peter Sasieni⁵, Emma J Crosbie^{1

2}

Affiliations

¹ Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
² Department of Obstetrics and Gynaecology, Manchester Academic Health Science Centre, St Mary's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
³ Cytology Department, Clinical Sciences Centre, Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Manchester, UK.
⁴ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
⁵ Centre for Cancer Prevention, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.

PMID: 38660737
DOI: 10.1111/1471-0528.17831

Abstract

Objective: To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices.

Design: Randomised controlled trial.

Setting: St Mary's Hospital, Manchester, UK.

Population: Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively.

Methods: Urine was self-collected and mixed with preservative - randomised 1:1 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability.

Main outcome measures: The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling.

Results: Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%-94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%-80.9%, 91/124, p = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87-0.97, p_McN = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees.

Conclusions: Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.

Keywords: Colli‐pee®; Roche cobas® 8800; cervical screening; clinical validation; diagnostic test accuracy; first‐void urine; human papillomavirus; human papillomavirus testing; self‐sampling.

Abstract

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