Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol

• Published in: Gynecologic oncology 2021-09, Vol.162 (3), p.575-583
• Main Authors: Van Keer, Severien, Peeters, Eliana, Vanden Broeck, Davy, De Sutter, Philippe, Donders, Gilbert, Doyen, Jean, Tjalma, Wiebren A.A., Weyers, Steven, Vorsters, Alex, Arbyn, Marc
• Format: Article
• Language: English
• Subjects: Abbott RealTime high risk HPV assay; Adult; Aged; Cervical cancer screening; Cervical Intraepithelial Neoplasia - diagnosis; Cervical Intraepithelial Neoplasia - urine; Cervical Intraepithelial Neoplasia - virology; Cervix Uteri - pathology; Cervix Uteri - virology; Clinical validation; Colli-pee; Diagnostic test accuracy; Early Detection of Cancer - methods; Female; First-void urine; HPV; HPV testing; Humans; Middle Aged; Papillomaviridae - isolation & purification; Papillomavirus Infections - diagnosis; Papillomavirus Infections - urine; Papillomavirus Infections - virology; Self-sampling; Urine - virology; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - urine; Uterine Cervical Neoplasms - virology; VALHUDES; Young Adult
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2021.06.010

Urine self-sampling has gained increasing interest for cervical cancer screening. In contrast to analytical performance, little information is available regarding the clinical accuracy for high-risk Human Papillomavirus (hrHPV) testing on urine. VALHUDES is a diagnostic test accuracy study comparing clinical accuracy to detect high-grade cervical precancer (CIN2+) of HPV testing on self-collected compared to clinician-collected samples (NCT03064087). Disease outcome was assessed by colposcopy and histology. The Abbott RealTime High Risk HPV assay performance was evaluated on Colli-Pee collected first-void urine with cervical outcomes as comparator. As no assay cut-off for urine has been clinically validated, we used the predefined cut-off for cervical samples (CN ≤ 32). Using this cut-off, hrHPV testing was similarly sensitive (relative sensitivity 0.95; 95% CI: 0.88–1.01) and specific (relative specificity 1.03; 95% CI: 0.95–1.13) for detection of CIN2+ compared to testing cervical samples. In the subgroup of women of 30 years and older, similar relative sensitivity (0.97; 95% CI: 0.89–1.05) and specificity (1.02; 95% CI: 0.93–1.12) was found. Additionally, an exploratory cut-off (CN ≤ 33.86) was defined which further improved sensitivity and analytical test performance. HrHPV-DNA based PCR testing on home-collected first-void urine has similar accuracy for detecting CIN2+ compared to cervical samples taken by a clinician. •First study to prove that HPV testing in home-collected first-void urine is a valid alternative to cervical samples.•A HPV DNA-based PCR platform, already used in routine cancer screening, assessed clinical accuracy of urinary HPV testing.•Compared to cervical samples, HPV testing in first-void urine showed equal clinical accuracy for CIN2+.•Outcome is pivotal to widen sampling strategies and reach un(der)-screened women by offering urine self-collection at home.