液体染色学串联质谱学 (LC-MS/MS) 是尿白蛋白的候选参考测量方法
Seiei Shiba1, Zoi E Sychev2, Michael D Evans3
1Advanced Research and Diagnostic Laboratory, Department of Laboratory Medicine and Pathology, 5635 University of Minnesota , Minneapolis, MN, USA.
标准化尿蛋白测量对于准确的慢性病诊断至关重要. 一种新的液体染色学双重质谱法提供了高精度和准确性,解决了关键的临床需求.
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:
- 尿中的白蛋白是诊断和监测慢性病 (CKD) 的重要生物标志物.
- 目前用于尿液白蛋白测量的实验室方法缺乏标准化,导致结果显著差异 (高达40%).
- 这种变化可能导致患者的错误分类,影响临床决策和疾病管理.
研究的目的:
- 开发和验证一个标准化参考测量程序 (RMP) 尿白蛋白.
- 为解决临床实验室中精确和可重现的尿蛋白量化的关键需求.
主要方法:
- 一种液态染色体双重质谱 (LC-MS/MS) RMP 是使用素蛋白解并准六种特定的人类血清白的方法开发的.
- 校准器使用NIST 2925参考材料进行了值分配.
- 来自98名患者的尿液样本被四倍地分析,以提高精度和准确性.
主要成果:
- LC-MS/MS RMP实现了极好的不精确度,20天变化系数 (CV) <3.0%.
- 与罗氏科巴斯和西门子维度Vista测试相比,RMP的偏差分别为-9.9%和20.1%.
- 总的不确定性被仔细计算,考虑从样本处理到LC-MS/MS不精确度的所有步骤.
结论:
- 开发的RMP实现了2.8%的整体CV,满足了标准化尿蛋白测量的性能规范 (CV ≤6.2%).
- 这种标准化方法为准确的尿蛋白量化提供了可靠的工具,对于有效的CKD管理至关重要.
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