Sansure®人乳头瘤病毒DNA检测试剂盒在高危HPV检测中的优异重现性表现

The Sansure® Human Papillomavirus DNA Diagnostic Kit offers excellent reproducibility performance for the detection of high-risk HPV

JOURNAL OF MEDICAL VIROLOGY

影响因子:4.6

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

DOI: 10.1002/jmv.29961

摘要

宫颈癌筛查是宫颈癌消除的基础。检测高危人乳头瘤病毒（hrHPV）被推荐作为筛查的第一步，前提是所用检测方法经过充分验证。Sansure®人乳头瘤病毒DNA检测试剂盒是一种新型检测HPV16、HPV18及其他13种HPV的联合检测方法。本研究旨在根据国际指南评估该试剂盒的实验室内和实验室间重现性。选取比利时HPV国家参考中心生物库中的550份宫颈残余细胞样本，用于本研究。DNA提取后，使用Sansure®试剂盒检测HPV。该试剂盒的总体重现性95%置信区间下限应≥87%，κ系数≥0.50。在533份有效样本中，试剂盒表现出极佳的实验室内重现性，达93.8%（95% 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）。在基因型水平，重现性亦表现优异。排除HPV53单一感染样本后，结果仍显示极佳的一致性。数据表明，Sansure®人乳头瘤病毒DNA检测试剂盒具有高度的重现性。

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.