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Xirui Zhou^1,2, Yanli Lu², Xinling Cui¹

¹Division of Chemical Metrology and Analytical Science, National Institute of Metrology, Beijing 100029, China.

Analytical chemistry

|June 27, 2025

概括

开发了一种新的Tau-441溶液认证参考材料 (CRM),以标准化阿尔茨海默病 (AD) 生物标志物测量. 这种CRM提高了Tau检测的准确性和可靠性,有助于早期AD诊断和治疗.

科学领域:

生物化学生物化学
生物标志物开发生物标志物开发
分析化学分析化学

背景情况:

蛋白是阿尔茨海默病 (AD) 的关键生物标志物.
目前的Tau检测方法显示了测试间的显著变异性,阻碍了准确的诊断.
标准化和可追溯性对于可靠的tau的临床测量至关重要.

研究的目的:

开发和认证Tau-441解决方案作为认证的参考材料 (CRM).
为了建立生物流体中Tau测量的可追溯性.
帮助标准化阿尔茨海默病的临床诊断和切断值.

主要方法:

使用高纯度的Tau-441.1,开发了Tau-441解决方案CRM (NIM-RM 2901).
候选CRM的纯度和结构确认.
使用三种独立的同位素稀释质谱学策略 (氨基酸,特征,硫) 进行认证.

主要成果:

-441溶液CRM (NIM-RM 2901) 获得了认证,其值为 (74.1 ± 3.6) μg g-1.1.
CRM在-20°C (7天) 和-70°C (13个月) 显示出良好的均性和令人满意的稳定性.
开发的CRM为tau量化提供了一个可追溯的标准.

结论:

开发的Tau-441解决方案CRM (NIM-RM 2901) 是阿尔茨海默病生物标志物定量化的可靠标准.
这种CRM将促进TAU蛋白临床试验的标准化.
它通过使二次校准仪和CRM能够赋值来支持AD的早期诊断.

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