Severien Van Keer1, Eliana Peeters2, Davy Vanden Broeck3, Philippe De Sutter4, Gilbert Donders5, Jean Doyen6, Wiebren A A Tjalma7, Steven Weyers8, Alex Vorsters9, Marc Arbyn10. 1. Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium. Electronic address: severien.vankeer@uantwerpen.be. 2. Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. 3. Laboratory of Molecular Pathology, AML Sonic Healthcare, Emiel Vloorsstraat 9, 2020 Antwerp, Belgium; National Reference Centre for HPV, Juliette Wytsmanstraat 14, 1050 Brussels, Belgium; AMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium; International Centre for Reproductive Health, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium. 4. Department Gynaecology-Oncology, UZ Brussel - VUB, Laarbeeklaan 101, 1090 Jette, Brussels, Belgium. 5. Department of Obstetrics and Gynaecology, General Regional Hospital Heilig Hart, Kliniekstraat 45, 3300 Tienen, Belgium; Femicare vzw, Clinical Research for Women, Gasthuismolenstraat 33, 3300 Tienen, Belgium; Department of Obstetrics and Gynaecology, Antwerp University Hospital (UZA), Drie Eikenstraat 655, 2650 Edegem, Belgium. 6. Department Gynaecology-Obstetrics, University Hospital Liège, Avenue de L'Hôpital 1, 4000 Liège, Belgium. 7. Multidisciplinary Breast Clinic, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital (UZA), Drie Eikenstraat 655, 2650 Edegem, Belgium; Molecular Imaging, Pathology, Radiotherapy, Oncology (MIPRO), Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium. 8. Department of Obstetrics and Gynecology, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium. 9. Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium. 10. Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Corneel Heymanslaan 10, 9000 Ghent, Belgium.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Caroline Lefeuvre; Hélène De Pauw; Anne-Sophie Le Duc Banaszuk; Adeline Pivert; Alexandra Ducancelle; Franck Rexand-Galais; Marc Arbyn Journal: Int J Public Health Date: 2022-02-24 Impact factor: 3.380