Institute of Molecular and Translational Medicine, Palacky University Olomouc, Olomouc, Czech Republic; Cancer Research Czech Republic, Olomouc, Czech Republic.
Fertimed Ltd., Olomouc, Czech Republic; Department of Biology, Faculty of Medicine and Dentistry, Palacky University Olomouc, Olomouc, Czech Republic.
J Mol Diagn. 2018 Nov;20(6):849-858. doi: 10.1016/j.jmoldx.2018.07.004. Epub 2018 Aug 28.
High-risk human papillomavirus (hrHPV) infection is a cause of cervical cancer development. The addition of hrHPV testing to cervical cancer screening and monitoring of cervical intraepithelial neoplasia treatment improves the efficacy of screening and treatment, respectively. Self-sampling for hrHPV testing seems a promising tool for increasing patient participation in cervical cancer screening. In this project, 1198 cervical swabs obtained by physicians and 176 cervicovaginal swabs obtained by self-sampling (not collected in parallel) were analyzed for the presence of 14 hrHPV genotypes using three commercially available assays in comparison. HPV DNA was detected in 21.2% of all samples (21% of cervical swabs and 22.7% of cervicovaginal swabs). The cobas 4800 HPV Test was the most sensitive (0.983) and specific (0.992) for hrHPV detection overall. The PapilloCheck HPV-Screening and LMNX Genotyping Kit HPV GP had comparable specificity with that of the cobas (0.989 and 0.955, respectively), but lesser sensitivity (0.897 and 0.909, respectively). In physician-obtained cervical swabs, the cobas showed the highest sensitivity and specificity (0.980 and 0.994, respectively) for hrHPV detection, whereas in cervicovaginal swabs, the cobas had the highest sensitivity (1.00), but the PapilloCheck had the highest specificity (0.993). In conclusion, all of the detection methods evaluated were highly sensitive and specific for hrHPV detection from both clinician-collected cervical swabs and self-sampled cervicovaginal swabs.
高危型人乳头瘤病毒（hrHPV）感染是宫颈癌发展的原因之一。在宫颈癌筛查中增加 hrHPV 检测，并监测宫颈上皮内瘤变的治疗，分别提高了筛查和治疗的效果。hrHPV 检测的自我采样似乎是增加患者参与宫颈癌筛查的有前途的工具。在本项目中，分析了 1198 例由医生采集的宫颈拭子和 176 例由自我采样（未并行采集）获得的宫颈阴道拭子，使用三种市售检测方法比较了 14 种 hrHPV 基因型的存在情况。在所有样本中（宫颈拭子的 21%和宫颈阴道拭子的 22.7%）均检测到 HPV DNA。总体而言， cobas 4800 HPV Test 对 hrHPV 检测的敏感性（0.983）和特异性（0.992）最高。PapilloCheck HPV-Screening 和 LMNX Genotyping Kit HPV GP 的特异性与 cobas 相当（分别为 0.989 和 0.955），但敏感性较低（分别为 0.897 和 0.909）。在医生采集的宫颈拭子中， cobas 对 hrHPV 检测的敏感性和特异性最高（分别为 0.980 和 0.994），而在宫颈阴道拭子中， cobas 的敏感性最高（1.00），但 PapilloCheck 的特异性最高（0.993）。总之，所有评估的检测方法对来自临床医生采集的宫颈拭子和自我采样的宫颈阴道拭子的 hrHPV 检测均具有高度敏感性和特异性。
