337 Urine high risk human papillomavirus testing as an alternative cervical screening strategy: the ACES studies

Introduction/Background Urine human papillomavirus (HPV) testing shows promise for cervical screening and may improve uptake. Our aim was to (1) determine the clinical performance of urine HPV for CIN2+ detection in colposcopy and general screening populations; and (2) ascertain its acceptability to regular and poor attenders of cervical screening, including people from LGBTQIA+ and ethnically diverse backgrounds. Methodology We tested matched cervical and urine samples for high-risk HPV using Roche cobas-8800 at cervical thresholds. Colposcopy clinic attendees were randomised to provide a first-void urine sample using the Colli-Pee® device (Novosanis, 10mls+preservative) or a standard pot. Primary care attendees collected their urine using the Colli-Pee device. The acceptability of urine HPV testing was assessed in trial participants and people from LGBTQIA+ and ethnically-diverse backgrounds using a co-created national survey. Results 465 colposcopy and 1059 primary care attendees provided matched samples (total n=1517). Their median age was 35.0 years (IQR 29–44) and 77.5% were White British. Urine HPV sensitivity for CIN2+ detection was higher with Colli-Pee (90.3%, 95%CI=83.7–94.9) than standard pot-collected urine (73.4%, 95%CI=64.7–80.9, p=0.0005). Urine sensitivity for CIN2+ detection was 91.2% (95%CI=85.2–95.4) vs 98.5% (95%CI=94.8–99.8, relative sensitivity 0.93) in cervical samples and specificity was 78.5% (95%CI=76.0–80.9) vs 80.5% (95%CI=78.1–82.8, relative specificity 0.98). Acceptability for urine-based cervical screening was good with 62.4% preferring urine/having no preference. Acceptability of urine sampling was further assessed in LGBTQIA+ and ethnically-diverse communities, with 47% of 211 transgender and 22% of 233 non-White individuals choosing urine as their preferred future screening method. Conclusion HPV tested Colli-Pee-collected urine shows similar test accuracy for CIN2+ detection compared to routine cervical screening. Improved test accuracy could be achieved with urine-specific thresholds for HPV positivity. Urine is broadly acceptable to attenders and some groups of non-attenders (eg LGBTQIA+) but others (eg ethnically diverse) may prefer clinician sampling, making choice important. Disclosures Roche provided this study with the testing kits to undergo the testing with the Roche Cobas 8800 hr-HPV assay. Novosanis provided the Colli-pee urine collection devices for the study. There are no other conflicts of interests.