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Comparison of the clinical accuracy of Xpert HPV assay on vaginal self-samples and cervical clinician-taken samples within the VALHUDES framework

Ardashel Latsuzbaia, Davy Vanden Broeck (UGent) , Severien Van Keer, Steven Weyers (UGent) , Gilbert Donders, Jean Doyen, Wiebren Tjalma, Philippe De Sutter, Alex Vorsters and Marc Arbyn (UGent)
(2023) JOURNAL OF MOLECULAR DIAGNOSTICS. 25(9). p.702-708
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Abstract
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. (J Mol Diagn 2023, 25: 702-708; https://doi.org/10.1016/j.jmoldx.2023.06.004)
Keywords
HUMAN-PAPILLOMAVIRUS ASSAYS, VALIDATION, PERFORMANCE, WOMEN, GUIDELINES, PROTOCOL, VALGENT, DNA

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MLA
Latsuzbaia, Ardashel, et al. “Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework.” JOURNAL OF MOLECULAR DIAGNOSTICS, vol. 25, no. 9, 2023, pp. 702–08, doi:10.1016/j.jmoldx.2023.06.004.
APA
Latsuzbaia, A., Vanden Broeck, D., Van Keer, S., Weyers, S., Donders, G., Doyen, J., … Arbyn, M. (2023). Comparison of the clinical accuracy of Xpert HPV assay on vaginal self-samples and cervical clinician-taken samples within the VALHUDES framework. JOURNAL OF MOLECULAR DIAGNOSTICS, 25(9), 702–708. https://doi.org/10.1016/j.jmoldx.2023.06.004
Chicago author-date
Latsuzbaia, Ardashel, Davy Vanden Broeck, Severien Van Keer, Steven Weyers, Gilbert Donders, Jean Doyen, Wiebren Tjalma, Philippe De Sutter, Alex Vorsters, and Marc Arbyn. 2023. “Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework.” JOURNAL OF MOLECULAR DIAGNOSTICS 25 (9): 702–8. https://doi.org/10.1016/j.jmoldx.2023.06.004.
Chicago author-date (all authors)
Latsuzbaia, Ardashel, Davy Vanden Broeck, Severien Van Keer, Steven Weyers, Gilbert Donders, Jean Doyen, Wiebren Tjalma, Philippe De Sutter, Alex Vorsters, and Marc Arbyn. 2023. “Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework.” JOURNAL OF MOLECULAR DIAGNOSTICS 25 (9): 702–708. doi:10.1016/j.jmoldx.2023.06.004.
Vancouver
1.
Latsuzbaia A, Vanden Broeck D, Van Keer S, Weyers S, Donders G, Doyen J, et al. Comparison of the clinical accuracy of Xpert HPV assay on vaginal self-samples and cervical clinician-taken samples within the VALHUDES framework. JOURNAL OF MOLECULAR DIAGNOSTICS. 2023;25(9):702–8.
IEEE
[1]
A. Latsuzbaia et al., “Comparison of the clinical accuracy of Xpert HPV assay on vaginal self-samples and cervical clinician-taken samples within the VALHUDES framework,” JOURNAL OF MOLECULAR DIAGNOSTICS, vol. 25, no. 9, pp. 702–708, 2023.
@article{01J151RE0JS4CR61ZY21MX2MFE,
  abstract     = {{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. (J Mol Diagn 2023, 25: 702-708; https://doi.org/10.1016/j.jmoldx.2023.06.004)}},
  author       = {{Latsuzbaia, Ardashel and Vanden Broeck, Davy and  Van Keer, Severien and Weyers, Steven and  Donders, Gilbert and  Doyen, Jean and  Tjalma, Wiebren and  De Sutter, Philippe and  Vorsters, Alex and Arbyn, Marc}},
  issn         = {{1525-1578}},
  journal      = {{JOURNAL OF MOLECULAR DIAGNOSTICS}},
  keywords     = {{HUMAN-PAPILLOMAVIRUS ASSAYS,VALIDATION,PERFORMANCE,WOMEN,GUIDELINES,PROTOCOL,VALGENT,DNA}},
  language     = {{eng}},
  number       = {{9}},
  pages        = {{702--708}},
  title        = {{Comparison of the clinical accuracy of Xpert HPV assay on vaginal self-samples and cervical clinician-taken samples within the VALHUDES framework}},
  url          = {{http://doi.org/10.1016/j.jmoldx.2023.06.004}},
  volume       = {{25}},
  year         = {{2023}},
}
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