Urine HPV testing for cervical screening in a UK general screening population: a diagnostic test accuracy study

Cervical screening uptake is decreasing in the UK. 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. To determine the clinical performance and acceptability of HPV-tested urine for cervical screening in a UK general screening population. Prospective, cross-sectional diagnostic test accuracy study in North-West England. Urine was self-collected using a first void urine collection device (Novosanis Colli-peeTM 10ml with urine conservation medium) prior to 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, were managed under standard NHS protocols and clinical outcomes were collected. 1517 participants provided matched urine and cervical samples. 207/1517 (13.6%) cervical and 245/1517 (16.2%) urine samples were HPV positive with a 1.6% incidence of cervical intraepithelial neoplasia-(CIN)2+ following colposcopic assessment (n=80). The specificity of urine was non-inferior (p<0.0001) to the specificity of cervical samples at 85.2% (95%CI=83.3-87.0) versus 87.8% (95%CI=86.0-89.4), giving a relative specificity of 0.97 (95%CI=0.95-0.99). Urine detected 24/25 (96%) participants with CIN2+. In the future, 41.6% of participants would prefer routine cervical screening, compared to 30.0% with no preference and 28.4% preferring self-sampling. 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 policy makers.