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不同的D-二聚体测定与年龄调整的截止值,以排除肺栓塞:ADJUST-PE研究的二次分析

Helia Robert-Ebadi¹, Christophe Combescure², Oana Bulla³

¹Division of Angiology and Hemostasis, Department of Medicine; Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.

Journal of thrombosis and haemostasis : JTH

|April 19, 2025

概括

根据年龄调整的D-二次数 (AADD) 切断值是安全的排除肺栓塞 (PE) 使用Innovance和LumiraDx测定. 然而,STA Liatest和Tinaquant测试显示PE诊断的虚假阴性率更高.

科学领域:

临床诊断临床诊断临床诊断
生物医学工程生物医学工程
医学实验室科学医学实验室科学

背景情况:

多中心前性ADJUST-PE研究确定了使用年龄调整的D-二分体 (AADD) 切断值排除肺栓塞 (PE) 的安全性.
以前的研究证实了AADD方法的有效性,证明了其在特定患者群体中安全排除PE的有效性.

研究的目的:

在日内瓦ADJUST-PE研究中的患者中使用AADD切线时评估各种D-二聚合物 (DD) 测定的安全性和性能.
使用AADD策略,将Innovance DD,STA Liatest,Tina-quant DD和LumiraDx点诊所测试的诊断准确性与VIDAS DD排除测试®进行比较.

主要方法:

在日内瓦,预先计划的ADJUST-PE队列的二次分析.
在解样本上重新测试VIDAS DD排除测试®,以确保可重现性.
分析包括Innovance DD,STA Liatest,Tina-quant DD和LumiraDx测试,评估静脉血栓栓塞 (VTE) 风险和AADD分类协议.

主要成果:

在597名分析患者中,14%的人在基线确认了PE;所有测试的DD试验都显示失败率低于2%.
在使用AADD时,Innovance DD和LumiraDx测试显示了与重复的VIDAS测试相似的分类结果.
在STA Liatest和Tina-quant DD测试中,负的AADD分类比例更高,分别有3名和5名患者尽管结果是负的,但仍患有PE.

结论:

通过使用AADD截止值,Innovance DD和LumiraDx测定被认为是PE排除的安全,与VIDAS测定相似.
STA Liatest和Tina-quant DD测定显示出更高的错误分类率,导致在负AADD结果的患者中潜在的PE诊断不足.

关键词:

根据年龄调整的截止时间.D-二聚子 D-二聚子诊断诊断诊断诊断诊断肺栓塞肺栓塞是一种肺栓塞.

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