Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol.

Autor:	Latsuzbaia A; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium., Van Keer S; 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 D; 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 S; Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium., Donders G; 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 P; Department Gynaecology-Oncology, UZ Brussel-VUB, Brussels, Belgium., Tjalma W; 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 J; Department Gynaecology-Obstetrics, University Hospital Liège, Liège, Belgium., Vorsters A; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Edegem (Antwerp), Belgium., Arbyn M; 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.
Jazyk:	angličtina
Zdroj:	The Journal of molecular diagnostics : JMD [J Mol Diagn] 2023 Dec; Vol. 25 (12), pp. 957-966. Date of Electronic Publication: 2023 Oct 20.
DOI:	10.1016/j.jmoldx.2023.09.008
Abstrakt:	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. (Copyright © 2023 Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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