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Clinical accuracy of alinity m HR HPV assay on self-versus clinician-taken samples using the VALHUDES protocol

Ardashel Latsuzbaia, Severien Van Keer, Davy Vanden Broeck (UGent) , Steven Weyers (UGent) , Gilbert Donders, Philippe De Sutter, Wiebren Tjalma, Jean Doyen, Alex Vorsters and Marc Arbyn (UGent)
(2023) JOURNAL OF MOLECULAR DIAGNOSTICS. 25(12). p.957-966
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Abstract
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 col-poscopy (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.
Keywords
HUMAN-PAPILLOMAVIRUS ASSAYS, CERVICAL-CANCER, URINE, DEVICES, VALIDATION, COLLECTION, MORTALITY

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MLA
Latsuzbaia, Ardashel, et al. “Clinical Accuracy of Alinity m HR HPV Assay on Self-versus Clinician-Taken Samples Using the VALHUDES Protocol.” JOURNAL OF MOLECULAR DIAGNOSTICS, vol. 25, no. 12, 2023, pp. 957–66, doi:10.1016/j.jmoldx.2023.09.008.
APA
Latsuzbaia, A., Van Keer, S., Vanden Broeck, D., Weyers, S., Donders, G., De Sutter, P., … Arbyn, M. (2023). Clinical accuracy of alinity m HR HPV assay on self-versus clinician-taken samples using the VALHUDES protocol. JOURNAL OF MOLECULAR DIAGNOSTICS, 25(12), 957–966. https://doi.org/10.1016/j.jmoldx.2023.09.008
Chicago author-date
Latsuzbaia, Ardashel, Severien Van Keer, Davy Vanden Broeck, Steven Weyers, Gilbert Donders, Philippe De Sutter, Wiebren Tjalma, Jean Doyen, Alex Vorsters, and Marc Arbyn. 2023. “Clinical Accuracy of Alinity m HR HPV Assay on Self-versus Clinician-Taken Samples Using the VALHUDES Protocol.” JOURNAL OF MOLECULAR DIAGNOSTICS 25 (12): 957–66. https://doi.org/10.1016/j.jmoldx.2023.09.008.
Chicago author-date (all authors)
Latsuzbaia, Ardashel, Severien Van Keer, Davy Vanden Broeck, Steven Weyers, Gilbert Donders, Philippe De Sutter, Wiebren Tjalma, Jean Doyen, Alex Vorsters, and Marc Arbyn. 2023. “Clinical Accuracy of Alinity m HR HPV Assay on Self-versus Clinician-Taken Samples Using the VALHUDES Protocol.” JOURNAL OF MOLECULAR DIAGNOSTICS 25 (12): 957–966. doi:10.1016/j.jmoldx.2023.09.008.
Vancouver
1.
Latsuzbaia A, Van Keer S, Vanden Broeck D, Weyers S, Donders G, De Sutter P, et al. Clinical accuracy of alinity m HR HPV assay on self-versus clinician-taken samples using the VALHUDES protocol. JOURNAL OF MOLECULAR DIAGNOSTICS. 2023;25(12):957–66.
IEEE
[1]
A. Latsuzbaia et al., “Clinical accuracy of alinity m HR HPV assay on self-versus clinician-taken samples using the VALHUDES protocol,” JOURNAL OF MOLECULAR DIAGNOSTICS, vol. 25, no. 12, pp. 957–966, 2023.
@article{01J151NFJ5QZ0RBF1GNW4JAJQD,
  abstract     = {{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 col-poscopy (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.}},
  author       = {{Latsuzbaia, Ardashel and  Van Keer, Severien and Vanden Broeck, Davy and Weyers, Steven and  Donders, Gilbert and  De Sutter, Philippe and  Tjalma, Wiebren and  Doyen, Jean and  Vorsters, Alex and Arbyn, Marc}},
  issn         = {{1525-1578}},
  journal      = {{JOURNAL OF MOLECULAR DIAGNOSTICS}},
  keywords     = {{HUMAN-PAPILLOMAVIRUS ASSAYS,CERVICAL-CANCER,URINE,DEVICES,VALIDATION,COLLECTION,MORTALITY}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{957--966}},
  title        = {{Clinical accuracy of alinity m HR HPV assay on self-versus clinician-taken samples using the VALHUDES protocol}},
  url          = {{http://doi.org/10.1016/j.jmoldx.2023.09.008}},
  volume       = {{25}},
  year         = {{2023}},
}
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