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用两种版本的帕皮洛普莱克斯高风险HPV测试进行HPV测试的可重复性

Pui Yan Jenny Chung¹, Alice Baraquin², Killian Jacquot²

¹Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.

Journal of medical virology

|November 1, 2025

概括

帕皮洛普莱克斯HR-HPV测定版本1在宫癌查中显示出高风险HPV检测的出色可重复性. 这完成了它的验证,满足了可靠使用的国际标准.

科学领域:

分子诊断学分子诊断学
妇科瘤学妇科瘤学
公共卫生公共卫生

背景情况:

宫癌查依赖于经过验证的临床准确性和可重复性的HPV测试.
帕皮洛普莱克斯HR-HPV测定 (版本1) 需要进行可复制性评估才能完全验证.
国际指南规定了HPV测试验证的具体性能值.

研究的目的:

为了评估Papilloplex HR-HPV测定版本1.1的实验室内和实验室间可重复性.
为了确定测试是否符合高风险HPV (hrHPV) 检测的确定的验证标准.
为了比较Papilloplex HR-HPV测定版本1与版本6以及不同的PCR分析方法的一致性.

主要方法:

使用了一个由550个冷保存的宫细胞样本组成的小组.
评估了Papilloplex HR-HPV版本1的实验室内和实验室间可重复性.
分析了测试版本 (v1和v6) 和PCR解释方法之间的一致性.

主要成果:

帕皮洛普莱克斯HR-HPV版本1显示出优异的实验室内可复制性 (97.5%, κ=0.94) 和实验室间可复制性 (93.5%, κ=0.85).
该试验符合可重复性的国际验证标准.
在Papilloplex HR-HPV版本1和6之间以及在三个PCR分析方法之间观察到极好的一致性.

结论:

帕皮洛普勒克斯HR-HPV测定版本1表现出极好的可重复性,满足宫癌查的国际验证要求.
测试的第6版本与第1版本高度一致,但需要临床验证.
该试验的性能支持其用于用于宫癌查计划的hrHPV检测.

关键词:

在HPV基因型鉴定中.宫癌:子宫癌是一种癌症.人类乳头瘤病毒人类乳头瘤病毒这种情况是因为papilloplex.可复制性的可复制性查检查查检查查检查查检查验证验证的时间

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