宫颈癌筛查是消除宫颈癌的基石。如果所使用的检测方法已得到充分验证，建议将高危人乳头瘤病毒 (hrHPV) 检测作为筛查的第一步。 Sansure® 人乳头瘤病毒 DNA 诊断试剂盒是一种新的检测方法，旨在总体检测 HPV16、HPV18 和其他 13 种 HPV。该研究旨在根据国际指南评估该测定的实验室内和实验室间重现性。从比利时 HPV 国家参考中心的生物库中选择了参加宫颈癌筛查的女性的 550 份宫颈残留细胞样本，并将其用于本研究。 DNA 提取后，使用 Sansure® 人乳头瘤病毒 DNA 诊断试剂盒检测 HPV。该测定的一般重现性的 95% 置信下限应大于或等于 87%，且 κ ≥ 0.50。五百三十三个样本有有效结果。 Sansure® 人乳头瘤病毒 DNA 诊断试剂盒表现出 93.8% 的出色实验室内重现性（95% 置信区间 [CI]：91.4-95.7，κ = 0.85）。实验室间重现性为 93.4 (95% CI: 91.0-95.4, κ = 0.84)。基因型水平的实验室内和实验室间重现性也非常出色。从分析中排除 HPV53 单一感染样本也得到了很好的一致性。这些数据表明 Sansure® 人乳头瘤病毒 DNA 诊断试剂盒具有高度可重复性。© 2024 作者。 《医学病毒学杂志》由 Wiley periodicals LLC 出版。

Cervical cancer screening is a cornerstone of cervical cancer elimination. Detection of high-risk human papillomavirus (hrHPV) is recommended as the first step in screening provided that the assay used has been adequately validated. The Sansure® Human Papillomavirus DNA Diagnostic Kit is a new assay designed to detect HPV16, HPV18 and 13 other HPV in aggregate. The study aimed to evaluate the intra- and interlaboratory reproducibility of the assay according to international guidelines. Five hundred and fifty cervical residual cell samples from women attending cervical cancer screening were selected from the biobank of the HPV National Reference Centre in Belgium and used in this study. After DNA extraction, HPV was tested using the Sansure® Human Papillomavirus DNA Diagnostic Kit. The lower 95% confidence limit around the general reproducibility of this assay should be greater than or equal to 87%, with κ ≥ 0.50. Five hundred and thirty-three samples had valid results. The Sansure® Human Papillomavirus DNA Diagnostic Kit demonstrated an excellent intra-laboratory reproducibility of 93.8% (95% confidence interval [CI]: 91.4-95.7, κ = 0.85). The interlaboratory reproducibility was 93.4 (95% CI: 91.0-95.4, κ = 0.84). Intra and interlaboratory reproducibility were also excellent at the genotype level. Excluding HPV53 single infection samples from the analyses also resulted in excellent agreement. These data show that the Sansure® Human Papillomavirus DNA Diagnostic Kit is highly reproducible.© 2024 The Author(s). Journal of Medical Virology published by Wiley Periodicals LLC.