Female; Humans; Human Papillomavirus Viruses; Papillomaviridae/genetics; Specimen Handling/methods; Early Detection of Cancer/methods; Sensitivity and Specificity; Uterine Cervical Neoplasms/diagnosis; Papillomavirus Infections/diagnosis; Uterine Cervical Dysplasia; Early Detection of Cancer; Papillomaviridae; Papillomavirus Infections; Specimen Handling; Uterine Cervical Neoplasms; Pathology and Forensic Medicine; Molecular Medicine
Abstract :
[en] The VALHUDES protocol was established to evaluate clinical accuracy of human papillomavirus (HPV) assays to detect cervical precancer on first-void urine (FVU) and vaginal self-samples versus matched clinician-collected cervical samples (CCSs). Here we evaluated clinical performance of Alinity m HR HPV assay in a colposcopy referral population. Home-collected FVU (Colli-Pee FV 5020) 1 day before colposcopy (n = 492), at-clinic collected dry vaginal self-samples [multi-Collect Swab (mC; n = 493), followed by Evalyn Brush (EB; n = 233) or Qvintip (QT; n = 260)] and matched CCSs, were available for the study. Sensitivity to detect cervical intraepithelial neoplasia grade 2 or higher (CIN2+) of Alinity testing on FVU (ratio, 0.94; 95% CI, 0.85-1.03), mC (ratio, 1.00; 95% CI, 0.94-1.06), and EB/QT (ratio, 0.92; 95% CI, 0.85-1.00) was not different to CCSs. Specificity on FVU was similar to CCS (ratio, 1.02; 95% CI, 0.95-1.10), whereas specificity on mC was lower (ratio, 0.83; 95% CI, 0.76-0.90), but on EB/QT was higher (ratio, 1.08; 95% CI, 1.01-1.15) than on CCS. Accuracy on EB (sensitivity ratio, 0.96; 95% CI, 0.87-1.05; specificity ratio, 1.18; 95% CI, 1.06-1.31) was slightly better than on QT (sensitivity ratio, 0.88; 95% CI, 0.75-1.03; specificity ratio, 1.00; 95% CI, 0.92-1.09). In conclusion, clinical sensitivity of Alinity assay on all self-sample types was similar to cervical specimens. Adjustment of signal thresholds improved assay's accuracy to detect CIN2+ in all self-sample types.
Disciplines :
Reproductive medicine (gynecology, andrology, obstetrics)
Author, co-author :
Latsuzbaia, Ardashel; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, 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 (Antwerp), Belgium
Vanden Broeck, Davy ; AMBIOR, Laboratory for Cell Biology and Histology, University of Antwerp, Edegem (Antwerp), Belgium, Laboratory of Molecular Pathology, University Hospital Liège, Liège, Belgium Sonic Healthcare, Antwerp, Belgium, National Reference Centre for HPV, Brussels, Belgium, International Centre for Reproductive Health, Ghent University, Ghent, Belgium
Weyers, Steven ; Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium
Donders, Gilbert; Department of Obstetrics and Gynaecology, General Regional Hospital Heilig Hart, Tienen, Belgium, Femicare vzw, Clinical Research for Women, Tienen, Belgium, Department of Obstetrics and Gynaecology, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital, Edegem, Belgium
De Sutter, Philippe ; Department Gynaecology-Oncology, UZ Brussel-VUB, Brussels, Belgium
Tjalma, Wiebren; Molecular Imaging, Pathology, Radiotherapy, Oncology, Faculty of Medicine and Health Sciences, University of Antwerp, Edegem, Belgium, Multidisciplinary Breast Clinic, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital, Edegem, Belgium
Doyen, Jean ; Université de Liège - ULiège > Département des sciences de la santé publique
Vorsters, Alex; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Edegem (Antwerp), 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 :
Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol.
Publication date :
2023
Journal title :
Journal of Molecular Diagnostics
ISSN :
1525-1578
eISSN :
1943-7811
Publisher :
Elsevier, United States
Volume :
25
Issue :
12
Pages :
957 - 966
Peer reviewed :
Peer Reviewed verified by ORBi
Funding text :
The VALHUDES project is a researcher-induced study, designed by Sciensano (principal investigator; Brussels, Belgium), Center for the Evaluation of Vaccination (University of Antwerp, Antwerp, Belgium), and Algemeen Medisch Laboratorium (Antwerp, Belgium). Manufacturers of human papillomavirus assays and devices can participate in the VALHUDES framework contributing equipment for laboratory testing and financial support for statistical analysis under the condition of accepting independent publication of results. This research was supported by a grant from Abbott Laboratories (Abbott Molecular Diagnostics, Des Plaines, IL), 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). A.V. is cofounder and former board member of Novosanis (Belgium), a spin-off company of the University of Antwerp, and was minority shareholder until January 2019. D.V.B. is employed by Algemeen Medisch Laboratorium (Antwerp, Belgium), part of the National Reference Center HPV, a private laboratory performing routine cervical cytology and human papillomavirus testing.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 Research Foundation\u2013Flanders junior postdoctoral fellowship 1240220N (S.V.K.).
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