Abstract：
Clinically validated human papillomavirus (HPV) assays are crucial in cervical cancer screening. In this study, we evaluated the Allplex HPV HR Detection assay (Seegene, SouthKorea) for its clinical accuracy and reproducibility according to the international criteria, using the RealTime High Risk HPV m2000 assay (Abbott, USA) as standard comparator. The Allplex HPV HR assay exhibits significant non-inferior sensitivity to detect cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+) with a ratio of 1.00 (95% CI: 0.97-1.03, P = 0.006), insignificant non-inferior sensitivity to detect CIN3+ with a ratio of 1.00 (95% CI: 0.88-1.13, P = 0.098), and non-inferior specificity to exclude CIN2+ with a ratio of 0.99 (95% CI: 0.99-1.00, P < 0.001) compared to the standard comparator. In addition, the assay shows an excellent reproducibility within the same laboratory [96.5% (95% CI: 94.6-97.9) with a kappa value of 0.91 (95% CI: 0.87-0.95)] and between laboratories [96.7% (95% CI: 94.8-98.0) with a kappa value of 0.91 (95% CI: 0.87-0.95)] for overall high-risk HPV positivity as well as for each individual HPV type. Pooling our study data with those of another independent study supports the consistency of our findings. We conclude that both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.IMPORTANCEThe clinical validation of human papillomavirus (HPV) assays in accordance with well-established international guidelines is crucial to ensure that only validated assays are used in the context of screening (Meijer et al., Int J Cancer, 2009). The guidelines, developed by an international consortium, require that a novel HPV assay has non-inferior accuracy against a standard comparator test for the detection of cervical intraepithelial neoplasia grade (CIN) 2 or worse (CIN2+). Additionally, a new HPV assay should meet specific criteria for both intra- and inter-laboratory reproducibility to ensure the assay consistently exhibits technical precision and robust performance. Pooling our study data with those of another independent study supports the consistency of our findings. In conclusion, both the clinical accuracy to detect cervical precancer and the reproducibility of Allplex HPV HR Detection assay fulfill the international validation criteria of use in cervical cancer screening.
摘要：
临床验证的人乳头瘤病毒（HPV）检测在宫颈癌筛查中至关重要。在这项研究中,我们评估了AllplexHPVHR检测试验(Seegene，韩国)根据国际标准的临床准确性和可重复性，使用实时高风险HPVm2000检测(雅培，美国)作为标准比较器。AllplexHPVHR测定对检测宫颈上皮内瘤变分级（CIN）2级或更差（CIN2）具有显着的非劣性敏感性，比率为1.00（95％CI：0.97-1.03，P=0.006），对检测CIN3+的敏感性不显著，比率为1.00(95%CI:0.88-1.13，P=0.098)，和非劣等特异性排除CIN2+，与标准比较相比，比率为0.99（95％CI：0.99-1.00，P<0.001）。此外,该分析在同一实验室内[96.5%(95%CI:94.6~97.9),kappa值为0.91(95%CI:0.87~0.95)]和实验室间[96.7%(95%CI:94.8~98.0),kappa值为0.91(95%CI:0.87~0.95)]以及每个HPV类型的整体高危型HPV阳性具有优异的重现性.将我们的研究数据与另一项独立研究的数据进行汇总支持我们的发现的一致性。我们得出的结论是，检测宫颈癌前病变的临床准确性和AllplexHPVHR检测测定的可重复性均符合宫颈癌筛查中使用的国际验证标准。重要意义根据完善的国际指南对人乳头瘤病毒（HPV）测定进行临床验证对于确保仅在筛选的情况下使用经过验证的测定至关重要（Meijer等人。,IntJ癌症，2009).准则,由国际财团开发，对于宫颈上皮内瘤变（CIN）2级或更差（CIN2+）的检测，要求新的HPV检测与标准比较试验相比具有非低劣的准确性。此外,新的HPV检测应满足实验室内和实验室间可重复性的特定标准,以确保检测始终具有技术精确性和稳健性能.将我们的研究数据与另一项独立研究的数据进行汇总支持我们的发现的一致性。总之,宫颈癌前病变的临床准确性和AllplexHPVHR检测试验的可重复性均符合宫颈癌筛查的国际验证标准.
