Abstract：
The implementation of cervical screening based on human papillomavirus (HPV) continues to progress rapidly across countries. Evidence has shown that assays detecting high-risk human papillomavirus (hrHPV) deoxyribonucleic acid (DNA) are more effective than cytology-based screening. Validation of new hrHPV DNA assays requires both noninferior clinical accuracy compared to a standard comparator for cervical precancer and good reproducibility. This study builds upon previous diagnostic accuracy assessments of the RIATOL HPV genotyping qPCR assay and aims to evaluate the international validation criteria for reproducibility. The intra- and interreproducibility of the RIATOL-qPCR assay were assessed using 550 remnant cervical cell material from the cytology archive of the National Reference Center for HPV in Belgium. Specimens were collected in the context of cervical cancer screening and tested in two different laboratories. The international reproducibility criteria include the lower bound of 95% confidence interval of the intra- and interlaboratory agreement regarding the detection of hrHPV DNA exceeding 87% with kappa ≥0.50. The RIATOL-qPCR assay demonstrated excellent intralaboratory reproducibility, achieving an overall agreement of 98.2 (95% CI 96.6-99.1%) and a kappa of 0.96. Interlaboratory testing showed an overall agreement of 98.5 (95% CI 97.1-99.4%) with a kappa of 0.97. The RIATOL-qPCR assay fulfills the third criterion for HPV test reproducibility requirement for use in cervical cancer screening.
摘要：
基于人乳头瘤病毒（HPV）的宫颈筛查的实施在各国继续迅速发展。证据表明，检测高风险人乳头瘤病毒（hrHPV）脱氧核糖核酸（DNA）的检测比基于细胞学的筛查更有效。与宫颈癌前病变的标准比较物相比，新的hrHPVDNA检测方法的验证需要临床准确性和良好的可重复性。本研究建立在先前对RIATOLHPV基因分型qPCR测定的诊断准确性评估的基础上，旨在评估可重复性的国际验证标准。使用来自比利时国家HPV参考中心细胞学档案的550个残余宫颈细胞材料评估了RIATOL-qPCR测定的内部和相互再现性。在宫颈癌筛查的背景下收集样本，并在两个不同的实验室进行测试。国际再现性标准包括关于kappa≥0.50的hrHPVDNA检测超过87％的实验室内和实验室间协议的95％置信区间的下限。RIATOL-qPCR分析显示出优异的实验室内可重复性，总体一致性为98.2（95%CI96.6-99.1%），κ为0.96。实验室间检测显示总体一致性为98.5（95％CI97.1-99.4％），κ为0.97。RIATOL-qPCR测定满足用于宫颈癌筛查的HPV测试再现性要求的第三个标准。
