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尿液高风险人类乳头瘤病毒检测作为例行宫查的替代方案:使用随机研究设计试验对两个尿液采集设备进行比较诊断准确性研究

Jennifer C Davies^1,2, Alexandra Sargent³, Elisabeth Pinggera¹

¹Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

BJOG : an international journal of obstetrics and gynaecology

|April 25, 2024

概括

使用专用设备收集的初空性尿液 (FVU) 的人类乳头瘤病毒 (HPV) 检测显示,在检测高度子宫癌前期癌症 (CIN2+) 方面,比标准尿液收集更高的灵敏度. 这种FVU尿液HPV测试是宫查的有希望的替代方案.

科学领域:

妇科瘤学妇科瘤学
分子诊断学分子诊断学
公共卫生查公共卫生查

背景情况:

宫癌查严重依赖于HPV检测.
目前的方法涉及侵入性宫取样.
基于尿的非侵入性HPV测试提供了一个潜在的替代方案.

研究的目的:

为了比较HPV测试在通过两种不同的设备检测2+级 (CIN2+) 宫内皮质瘤的尿液中收集的敏感度.
评估HPV检测自收集尿液的可接受性.

主要方法:

一项随机对照试验,涉及480名科尔波斯科比参与者,宫查结果异常.
参与者自行收集尿液,使用第一空尿 (FVU) 收集装置或标准.
为了进行比较,获得了临床医生采集的匹配的宫样本.
在所有样本上进行了HPV检测,使用罗氏cobas® 8800系统.

主要成果:

在FVU设备收集尿液的HPV测试显示,CIN2+检测的敏感性 (90.3%) 与标准收集 (73.4%) 相比显著更高.
在FVU设备收集的尿液HPV测试的相对灵敏度接近临床医生收集的宫样本的相对灵敏度.
发现尿液自取样对参与者来说是可以接受的.

结论:

使用专用设备收集第一空的尿液可以提高HPV测试的灵敏度,用于检测高度子宫癌前期.
用FVU设备收集的尿液HPV检测显示出临床前景,作为传统宫查的非侵入性替代方案.
需要在一般人群中进行进一步的研究,以确定其临床性能和可接受性.

关键词:

科利·皮® (Colli‐pee®) 是一种可爱的美食.罗奇科巴斯® 8800 的产品宫部查宫部查宫部查临床验证临床验证诊断测试的准确性诊断测试的准确性第一个空白尿液.人类乳头瘤病毒人类乳头瘤病毒人类乳头瘤病毒检测测试自己采样自取样.

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