Female; Humans; Adult; Papillomaviridae/genetics; Vagina; Specimen Handling; Sensitivity and Specificity; Early Detection of Cancer; Uterine Cervical Neoplasms; Papillomavirus Infections/diagnosis; Uterine Cervical Dysplasia; Papillomaviridae; Papillomavirus Infections; Pathology and Forensic Medicine; Molecular Medicine
Abstract :
[en] The accuracy of high-risk human papillomavirus testing with the Xpert HPV assay on vaginal self-samples was compared with clinician-taken samples within the VALidation of HUman papillomavirus assays and collection DEvices for Self-samples and urine samples (VALHUDES) framework. Five-hundred and twenty-three women were recruited in five Belgian colposcopy clinics, of whom 483 (median age, 40 years; interquartile range, 31 to 49 years) were included in the main analysis (226 collected with Evalyn Brush and 257 collected with Qvintip). Cervical samples were collected with Cervex-Brush. Colposcopy and histology outcomes were considered as the reference standard. The Xpert HPV assay had similar accuracy for cervical intraepithelial neoplasia ≥2 on self-collected versus clinician-collected samples [relative sensitivity, 0.96 (95% CI, 0.91-1.02); and relative specificity, 0.96 (95% CI, 0.89-1.04)]. The relative accuracy slightly differed by vaginal collection device [sensitivity ratios of 0.98 (95% CI, 0.90-1.06) and 0.94 (95% CI, 0.87-1.02) for Evalyn and Qvintip, respectively; specificity ratios of 1.06 (95% CI, 0.95-1.19) and 0.88 (95% CI, 0.80-0.98) for Evalyn and Qvintip, respectively]. No difference in cycle threshold values was observed between vaginal and cervical samples. In conclusion, the sensitivity of Xpert HPV assay for cervical intraepithelial neoplasia ≥2 on vaginal self-samples was similar to that of cervical specimens. The clinical specificity was lower than on clinician-collected samples when self-samples were taken with Qvintip.
Disciplines :
Reproductive medicine (gynecology, andrology, obstetrics)
Author, co-author :
Latsuzbaia, Ardashel; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium
Vanden Broeck, Davy; Laboratory of Molecular Pathology, Algemeen Medisch Laboratorium Sonic Healthcare, Antwerp, Belgium, National Reference Centre for HPV, Brussels, Belgium, AMBIOR, Laboratory for Cell Biology and Histology, University of Antwerp, Antwerp, Belgium, International Centre for Reproductive Health, Ghent University, Ghent, Belgium
Van Keer, Severien; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Edegem, Belgium
Weyers, Steven; Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium
Donders, Gilbert ; Department of Obstetrics and Gynaecology of the General Regional Hospital Heilig Hart, Tienen, Belgium, Femicare vzw, Clinical Research for Women, Tienen, Belgium, Department of Obstetrics and Gynaecology, University Hospital Antwerp, Antwerp, Belgium
Doyen, Jean ; Université de Liège - ULiège > Département des sciences de la santé publique
Tjalma, Wiebren; Multidisciplinary Breast Clinic, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital, Edegem, Belgium, Molecular Imaging, Pathology, Radiotherapy, Oncology, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium
De Sutter, Philippe ; Department Gynaecology-Oncology, University Hospital Brussels, Brussels, Belgium
Vorsters, Alex ; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Edegem, Belgium
Arbyn, Marc ; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium, Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium. Electronic address: marc.arbyn@sciensano.be
Language :
English
Title :
Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework.
Publication date :
2023
Journal title :
Journal of Molecular Diagnostics
ISSN :
1525-1578
eISSN :
1943-7811
Publisher :
Elsevier, United States
Volume :
25
Issue :
9
Pages :
702 - 708
Peer reviewed :
Peer Reviewed verified by ORBi
Funding text :
Supported by the Risk-based Screening for Cervical Cancer (RISCC) Network grant 8478459, funded by the Horizon 2020 Program for Research and Innovation of the European Commission (Brussels, Belgium; M.A. and A.L.); and a junior postdoctoral fellowship of the Research Foundation Flanders 1240220N (S.V.K.).Disclosures: The VALHUDES project is a researcher-driven study, designed by Sciensano (Brussels, Belgium; principal investigator), Centre for the Evaluation of Vaccination (University of Antwerp, Edegem, Belgium), and Algemeen Medisch Laboratorium (Antwerp, Belgium). Manufacturers of human papillomavirus assays and devices can participate in the VALHUDES framework, contributing financial support and equipment for laboratory testing and statistical analysis under the condition of accepting independent publication of results. This research was supported by Cepheid (Sunnyvale, CA), Novosanis NV (Wijnegem, Belgium), and University of Antwerp. The study group received sample collection devices from Rovers Medical Devices B.V. (Oss, the Netherlands) and Aprovix AB (Uppsala, Sweden).
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