Sansure®人乳头瘤病毒DNA诊断试剂盒为检测高风险HPV提供了出色的可重复性性能
The Sansure® Human Papillomavirus DNA Diagnostic Kit offers excellent reproducibility performance for the detection of high-risk HPV
影响因子:4.60000
分区:医学3区 / 病毒学3区
发表日期:2024 Oct
作者:
Jean-Luc Prétet, Alice Baraquin, Pui Yan Jenny Chung, Line Puget, Sharonjit K Dhillon, Yuliya Tkachenka, Killian Jacquot, Quentin Lepiller, Davy Vanden Broeck, Marc Arbyn
摘要
宫颈癌筛查是消除宫颈癌的基石。建议检测高危人乳头瘤病毒（HRHPV），前提是筛查的第一步，只要使用了充分的测定法。 Sansure®人乳头瘤病毒DNA诊断试剂盒是一种新的测定法，旨在检测HPV16，HPV18和13个其他HPV的HPV。该研究旨在根据国际准则评估测定法的内部和间室内可重复性。从比利时HPV国家参考中心的生物库中选择了来自参加宫颈癌筛查的女性的五十五十个宫颈残留细胞样本，并在本研究中使用。 DNA提取后，使用Sansure®人乳头瘤病毒DNA诊断试剂盒对HPV进行了测试。该测定法的一般可重复性周围的较低95％置信度限制应大于或等于87％，κ≥0.50。五百三十三个样本具有有效的结果。 Sansure®人乳头瘤病毒DNA诊断试剂盒表现出极好的实验室可重现性为93.8％（95％置信区间[CI]：91.4-95.7，κ= 0.85）。实验室间的可重复性为93.4（95％CI：91.0-95.4，κ= 0.84）。在基因型水平上，实验室内和实验室的可重复性也非常出色。从分析中不包括HPV53单一感染样品也导致了极好的一致性。这些数据表明，Sansure®人乳头瘤病毒DNA诊断试剂盒高度可重现。
Abstract
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.