Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
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.
J Mol Diagn. 2023 Sep;25(9):702-708. doi: 10.1016/j.jmoldx.2023.06.004. Epub 2023 Jun 22.
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.
在 VALidation of HUman papillomavirus assays and collection DEvices for Self-samples and urine samples（VALHUDES）框架内，比较了 Xpert HPV 检测在阴道自我采样与临床医生采集样本时对高危型人乳头瘤病毒检测的准确性。该研究在比利时的五个阴道镜检查诊所招募了 523 名女性，其中 483 名（中位年龄 40 岁；四分位间距 31 至 49 岁）被纳入主要分析（226 名使用 Evalyn 刷采集，257 名使用 Qvintip 采集）。宫颈样本使用 Cervex-Brush 采集。将阴道镜检查和组织学结果作为参考标准。Xpert HPV 检测在自我采集与临床医生采集样本中对宫颈上皮内瘤变≥2 的准确性相似[相对敏感度，0.96（95%CI，0.91-1.02）；相对特异性，0.96（95%CI，0.89-1.04）]。阴道采集装置略有不同，检测结果也略有不同[Evalyn 的敏感度比值为 0.98（95%CI，0.90-1.06），Qvintip 的敏感度比值为 0.94（95%CI，0.87-1.02）；Evalyn 的特异性比值为 1.06（95%CI，0.95-1.19），Qvintip 的特异性比值为 0.88（95%CI，0.80-0.98）]。阴道和宫颈样本的循环阈值值无差异。结论：Xpert HPV 检测在阴道自我采样中对宫颈上皮内瘤变≥2 的敏感性与宫颈标本相似。当使用 Qvintip 进行自我采样时，其临床特异性低于临床医生采集的样本。
