Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First‐Void Urine Collector

Urine-based self-sampling approaches can simplify cervical screening programs whilst increasing response. This study reports on the performance of Abbott Alinity m HR HPV on urine, self-collected at home using a new generation first-void urination device that is suitable for postal delivery (Novosanis Colli-Pee Small Volumes). First-void urine and paired cervical samples from 297 females attending colposcopy (age 25-65, NCT04530201) were analysed for the presence of Human Papillomavirus (HPV) DNA. Cervical disease was confirmed by colposcopy and/or histology. HPV testing on first-void urine was less sensitive for high-grade cervical intraepithelial neoplasia (CIN2 +; ratio 0.91; 95% CI: 0.83-0.99), though equally specific (< CIN2; ratio 1.04; 95% CI: 0.92-1.19) compared to cervical samples at the manufacturer established cut-off for cervical samples. Adjusting the cut-off for first-void urine improved sensitivity for CIN2+ (ratio 0.96; 95% CI: 0.90-1.03), whilst maintaining equal specificity compared to cervical samples (ratio 1.00; 95% CI: 0.88-1.14). Cohen's kappa agreements of HPV outcomes between sample pairs were good to excellent at both cut-offs (range: 0.64-0.85). Using the HPV test's adjusted cutoff for first-void urine, no difference in clinical sensitivity or specificity was observed between first-void urine and cervical samples. These data highlight the importance of evaluating self-sample-specific cut-offs for HPV assays, previously validated on cervical samples.