875P - Performance and diagnostic accuracy of human papillomavirus testing on urine and self-collected vaginal samples in a referral population

Background

Human papillomavirus (HPV) is well established as the main cause of cervical cancer. Non-invasive self-collected urine and vaginal sampling have the potential advantage of increasing patient compliance with cervical cancer screening.

Methods

Women referred for colposcopy at Korea University Guro Hospital, following abnormal cytology, were included this study. A total of 314 paired urine, vaginal and cervical samples were collected. Primary endpoints were sensitivity for CIN2+/CIN3+ and specificity for

Results

For clinician-collected cervical samples, Sejong Realtime HR-S HPV test sensitivity for detecting and specificity from were similar to well-established test (Anyplex™ II HPV 28) [sensitivity for CIN3+ (n=109) 93.27% (95% confidence interval (CI), 86.62–97.25); CIN2+ (n=130) 92.74% (95% CI, 86.67–96.63); specificity for

Conclusions

HPV tests using urine and vaginal samples were still inferior to clinician-collected cervical samples in terms of detecting CIN2/3. However, these results indicate that combination of cytology with reflex hrHPV test using vaginal and urine samples may offer a reliable strategy for discriminating women at greater risk of precancerous lesion, increasing compliance of patients.

Clinical trial identification

NCT03409471.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Korea Health Industry Development Institute (KHIDI) (grant number: HI17C2229).

Disclosure

All authors have declared no conflicts of interest.