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Updated: Sep 11, 2025

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新的Sysmex高灵敏度Troponin T试验的分析性能

Chin Shern Lau¹, Napthathorn Asavapuriyothin², Chee Hoe Low²

¹Department of Laboratory Medicine, Changi General Hospital, Singapore 529889, Singapore.

Diagnostics (Basel, Switzerland)

|August 14, 2025

概括

Sysmex HISCL hs-cTnT测定是一种高灵敏度的热素测定方法,其性能与罗氏测定方法相当. 随着年龄的增长和功能下降,基线热波水平会增加.

科学领域:

临床化学临床化学
心血管诊断心血管诊断服务
免疫测试技术免疫测试技术

背景情况:

高灵敏度的心脏托罗素T (hs-cTnT) 测定对于诊断急性心肌梗塞至关重要.
评估新型诊断平台,如Sysmex高度集成的单子发光免疫检测系统 (HISCL),对于临床实践至关重要.
与已建立的测试进行比较,并确定参考限值是关键绩效指标.

研究的目的:

为了评估Sysmex HISCL hs-cTnT试验的分析性能.
为了比较其性能与罗氏hs-cTnT测定.
在健康人群中确定99百分位数上限 (99%的URL),并评估年龄和估计的球过率 (eGFR) 的影响.

主要方法:

测试验证包括空白/检测,精度和功能灵敏度的极限.
使用线性回归和布兰德-阿尔特曼分析进行了Sysmex HISCL和罗氏Elecsys分析仪之间的方法比较.
99%的URL来自健康的队列 (n=1004),并分析了年龄和eGFR对hs-cTnT水平的影响.

主要成果:

在HISCL测定显示低检测极限 (1.3 ng/L) 和空白 (1.9 ng/L),具有良好的精度 (CVs<10%在99%的URL).
与罗氏试验 (r=0.95) 观察到非常好的一致性,平均差异很小.
99%的URL被确定为14.4 ng/L (总体),17.0 ng/L (男性) 和13.9 ng/L (女性),hs-cTnT水平随着年龄的增长而增加并减少eGFR.

结论:

赛斯麦克斯HISCL hs-cTnT测定方法符合高灵敏度测定方法的标准.
它表现出可靠的性能和与比较试验的良好一致性.
确定的99%的URL和观察到的年龄/eGFR效应是临床解释的重要考虑因素.

关键词:

急性冠状动脉综合征急性冠状动脉综合征免疫测试是一种免疫测试.这种药物是托罗波尼因 (troponins).

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