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在3个候选质谱参考测量程序中,尿蛋白结果的等价程度

W Greg Miller¹, Lorin M Bachmann¹, Jeffrey Budd²

¹Department of Pathology, Virginia Commonwealth University, Richmond, VA, United States.

Clinical chemistry

|August 29, 2024

概括

标准化尿蛋白 (UA) 测量对于诊断慢性病至关重要. 使用质谱的新参考测量程序 (RMP) 显示出良好的一致性和低不确定性,使得诊断设备的可追溯性更为准确.

科学领域:

临床化学临床化学
生物标记分析生物标记分析
质谱测量质量谱测量

背景情况:

尿中的白蛋白 (UA) 是慢性病 (CKD) 的关键生物标志物.
目前用于UA的体外诊断医疗器械 (IVD-MDs) 缺乏标准化,导致显著的结果变化 (约. 45%的中位数差异).
计量可追溯性需要更高层次的参考测量程序 (RMP) 进行准确的UA解释.

研究的目的:

评估三位候选液体染色学-并联质谱学 (LC-MS/MS) RMPs用于尿蛋白测量.
评估这些RMP的测量可追溯性的一致性和不确定性.

主要方法:

通过使用三个候选LC-MS/MS RMP,分析了8个一次性捐赠的人类尿样.
统计分析包括t测试和差异组件分析,以比较结果并评估可变性.

主要成果:

在每个RMP实验室的平均结果和整体平均值之间没有发现统计学上显著的差异.
在三个RMP实验室中,总变化系数 (CV) 的中位数为6.23%.
所有候选RMP都满足了理想和最佳的标准不确定性规范 (分别为≤4.3%和≤3.3%).

结论:

开发的LC-MS/MS RMP显示了在标准化UA测量中使用的合适协议和低不确定性.
这些RMP可以为最终用户的IVD-MD提供计量可追溯性,提高CKD的诊断准确性.

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