Urine human papillomavirus testing for cervical screening in a UK general screening population: a diagnostic test accuracy study.

BACKGROUND: Cervical screening uptake is decreasing in the UK, with only 67.5% of those eligible under 50 years old attending in 2022. Barriers include restricted access to screening appointments and poor acceptability of the speculum examination. Urine self-sampling is an alternative cervical screening method that has the potential to improve uptake.

AIM: To determine the clinical performance and acceptability of human papillomavirus (HPV)-tested urine for cervical screening in a UK general screening population.

DESIGN AND SETTING: Prospective, cross-sectional diagnostic test accuracy study in North-West England.

METHOD: Urine was self-collected using a first-void urine (FVU) collection device (DNA Genotek Colli-Pee® 10 ml with urine conservation medium) before obtaining matched routine cervical screening samples. HPV testing used Roche Cobas® 8800 at cervical sample thresholds. A questionnaire evaluated urine self-sampling acceptability. HPV-positive cervical samples underwent reflex cytology, managed under standard NHS protocols, and clinical outcomes were collected.

RESULTS: In total, 1517 participants provided matched urine and cervical samples. There were 207 of 1517 (13.6%) cervical and 245 of 1517 (16.2%) urine samples that were HPV positive with a 1.6% (n = 25/1517) incidence of cervical intraepithelial neoplasia (CIN)2+ following colposcopic assessment (n = 80). The specificity of urine was non-inferior (P = 0.0004) to the specificity of cervical samples at 85.19% (95% confidence interval [CI] = 83.28 to 86.95) versus 87.80% (95% CI = 86.03 to 89.42), giving a relative specificity of 0.97 (95% CI = 0.95 to 0.99). Urine detected 24 of 25 (96.0%) participants with CIN2+. In the future, 41.6% (n = 575/1382) of participants would prefer current cervical screening, compared with 30.0% (n = 414/1382) with no preference and 28.4% (n = 393/1382) preferring urine self-sampling.

CONCLUSION: HPV-tested urine showed non-inferior specificity to cervical samples in a general screening population. Urine self-sampling was acceptable to current attenders but some prefer traditional screening, making choice an important consideration for policymakers.