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基于同位素稀释液体色谱 (ID-LC-MS/MS) 的候选参考测量程序的开发和验证,用于人类血清中总3,3',5-triiodothyronine的测量

Wenya Li¹, Bingling Gao¹, Tao Yang¹

¹Maccura Biotechnology Co., Ltd, Chengdu, 611731, China.

Analytical and bioanalytical chemistry

|March 22, 2025

概括

开发了一种新的,简化的测量血清中三甲氨酸 (T3) 总量的方法,使用同位素稀释液色谱与并列质谱 (ID-LC-MS/MS). 这种SI可追溯的方法增强了甲状腺疾病诊断和测试标准化.

科学领域:

临床化学临床化学
分析化学分析化学
质谱测量质量谱测量

背景情况:

3,3',5-Triiodothyronine (T3) 对于诊断甲状腺疾病至关重要.
现有的T3的参考测量程序 (RMP) 已经使用了20年.
提高T3测量的精度和效率对于临床实验室至关重要.

研究的目的:

开发和验证一种简化,SI可追溯的血清总T3 (TT3) 候选RMP.
通过整合精简的样本准备流程来改进当前的RMP.
确保新方法可靠,适合常规测试标准化.

主要方法:

使用同位素稀释液体色谱与并联质谱学 (ID-LC-MS/MS) 的方法.
一个简化的血清清洁涉及蛋白质沉和干燥.
方法验证遵循ISO指南,包括测量不确定性评估.

主要成果:

该方法表现出高线性 (0.016到13.086nmol/L) 和低不精确性 (内测0.11.9%,间测0.51.2%).
偏差是最小的 (SRM971的0.34至-1.65%),与现有RMP的一致性是很好的 (平均偏差在6%内).
测量不确定性被确定为0.022nmol/L和0.120nmol/L对于不同的参考材料.

结论:

开发的候选RMP可追溯,可靠,易于使用.
这种方法显示出标准化血清T3试验的巨大潜力.
它促进了用于甲状腺激素分析的新血清参考材料的开发.

关键词:

在ID-LC-MS/MS中使用.参考测量程序参考测量程序可以追溯的SI-可追溯血清 3,3′,5 三胺氨酸.甲状腺是什么?甲状腺是什么?

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