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贝克曼·科尔特心脏特罗邦尼I试验的可比性

Caroline G Stanek¹, Jose Lima¹, Liyun Cao²

¹Department of Pathology, The University of Alabama at Birmingham, Birmingham AL, USA.

Annals of clinical and laboratory science

|July 24, 2024

概括

贝克曼·科尔特心脏热素I (cTnI) 试验在同一仪器上使用时显示出可比的结果,但当代和高灵敏度试验之间存在差异,特别是在较低水平. 建议报告特定的测定和仪器,以获得准确的解释.

科学领域:

临床化学临床化学
生物标记分析生物标记分析
心血管诊断心血管诊断服务

背景情况:

心脏热素I (cTnI) 是诊断心肌损伤的关键生物标志物,在急性心肌梗塞评估中,高于上限参考值 (URL) 99 百分位的变化至关重要.
准确测量cTnI对于及时和正确的患者管理至关重要.

研究的目的:

评估贝克曼·科尔特当代cTnI AccuTnI+3试验和高灵敏度cTnI (hs-cTnI) 试验之间的分析性能和一致性.
评估hs-cTnI结果在不同贝克曼·科尔特仪器 (DXI 800和Access 2) 中的一致性.

主要方法:

在DXI 800仪器上使用AccuTnI+3和hs-cTnI测定分析了424个患者样本.
从Access 2和DXI 800仪器使用115个患者样本进行hs-cTnI结果的比较.

主要成果:

在DXI 800上进行的两种方法之间的比较显示出良好的相关性 (CC=0.9590),但在20 ng/L以下的水平上显著偏差 (-5.16%).
在Access 2和DXI 800上的hs-cTnI的方法内比较显示了整体高一致性 (CC=0.9915).
在低于200 ng/L (CC=0.9951) 的水平下,hs-cTnI结果在仪器之间更容易比较.

结论:

当代AccuTnI+3和hs-cTnI测定在DXI 800上产生了可比的结果,特别是在99百分点以上.
在Access 2和DXI 800仪器之间,hs-cTnI结果是可比的,特别是在低于200 ng/L的度下.
实验室应报告使用的特定心脏热素测定和仪器,以防止对结果的误解.

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