从参考实验室使用改进的Alinity i分析仪的CMIA和LC-MS/MS方法的塔克罗利斯度之间的良好相关性,但从不同的参考实验室使用另一种LC-MS/MS方法的意想不到的负偏差
Kelsey Woodard1, Tracey Kisler1, Amitava Dasgupta2
1Clinical Laboratories, University of Kansas Hospital, Kansas City, KS, US.
American journal of clinical pathology
|February 12, 2024
概括
塔克罗利斯的Alinity i化学发光微粒子免疫试验 (CMIA) 显示出极好的精度. 它与来自一个实验室的LC-MS/MS有很好的相关性,支持其在治疗药物监测中的使用.
科学领域:
- 临床化学 临床化学
- 分析化学 分析化学
- 药理学 药理学是指药理学的学科.
背景情况:
- 塔克罗利斯是一种重要的免疫抑制药物.
- 准确的治疗药物监测 (TDM) 对于塔克罗利斯的有效性和安全性至关重要.
- 较新的测定需要根据已确定的方法进行验证.
研究的目的:
- 为了比较来自Alinity i CMIA测定中的塔克罗利斯度与液态染色学/并联质谱学 (LC-MS/MS) 参考方法.
- 为了评估Alinity i CMIA和Elecsys tacrolimus测定之间的相关性.
主要方法:
- 在全血中测量了塔克罗利斯度,使用Alinity和CMIA测定.
- 样品被两个独立的参考实验室分析,使用LC-MS/MS与阿斯科米辛作为内部标准.
主要成果:
- 艾利尼蒂和CMIA测定显示出极好的总精度.
- 当将CMIA结果与参考实验室A的LC-MS/MS进行比较时,观察到强烈的相关性 (r=0.95) 和没有显著的偏差.
- 当将CMIA结果与参考实验室B的LC-MS/MS进行比较时,发现了显著的负偏差 (r=0.93).
- 来自CMIA和Elecsys免疫试验的塔克罗利斯度是可比的.
结论:
- 艾利尼蒂和CMIA测定显示了与主要参考实验室的LC-MS/MS的良好相关性.
- 性和CMIA测定适用于对塔克罗利斯的治疗药物监测.
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