基于人乳头瘤病毒（HPV）的宫颈筛查在各国持续快速推进。证据表明，检测高危型人乳头瘤病毒（hrHPV）脱氧核糖核酸（DNA）的检测法比以细胞学为基础的筛查更有效。新的hrHPV DNA检测法的验证需要在宫颈癌前病变筛查中与标准比较法具有非劣效的临床准确性，并且具有良好的再现性。本研究基于之前对RIATOL HPV基因分型荧光定量聚合酶链反应（qPCR）检测法的诊断准确性评估，并旨在评估国际再现性验证标准。利用比利时国家HPV参考中心的细胞学档案中550个剩余宫颈细胞样本，评估了RIATOL-qPCR检测法的内、间再现性。这些样本是在宫颈癌筛查背景下收集的，并在两个不同的实验室进行测试。国际再现性标准包括了关于hrHPV DNA检测的内、间实验室一致性的95%置信区间的下限超过87%，kappa值≥0.50。RIATOL-qPCR检测法显示出优秀的内实验室再现性，总一致性达到98.2%（95% CI 96.6-99.1%），kappa值为0.96。间实验室测试显示总一致性为98.5%（95% CI 97.1-99.4%），kappa值为0.97。RIATOL-qPCR检测法满足在宫颈癌筛查中使用的HPV检测再现性需求的第三个标准。© 2023 作者。由Wiley Periodicals LLC出版的《医学病毒学杂志》发布。

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.© 2023 The Authors. Journal of Medical Virology published by Wiley Periodicals LLC.