生物标志物 生物标志物
Batxelli-Molina Isabelle1, Vidal Elisa1, Lima-Guerin Aline1
1Eurofins ADME Bioanalyses, VERGEZE, Occitanie, France.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
概括
这项研究开发了一种质量控制 (QC) 样本的协议,以确保临床试验中精确的神经生物标志物测量. 经过验证的QC样本在EDTA血中显示稳定性,支持可靠的生物标志物测试.
科学领域:
- 生物化学 生物化学
- 临床化学 临床化学
- 生物标志物发现发现
背景情况:
- 在GLP/GCP环境中提供高质量的生物标记服务需要了解影响测试准确性的变量.
- 临床前和临床研究需要强大的神经生物标志物测量.
- 这项研究解决了用于神经生物标志物分析的可靠质量控制 (QC) 样本的需求.
研究的目的:
- 详细介绍一个实验协议,用于创建用于神经生物标志物测量的QC样本.
- 为了评估这些QC样本在生物矩阵中的稳定性.
- 确保临床研究中的生物标志物测试结果的准确性和稳定性.
主要方法:
- 从健康个体收集全血,在一小时内加工成EDTA血.
- 使用Lumipulse和Mesoscale发现平台测量了Aß1-40,Aß1-42,pTau217和NF-L的基线度.
- 通过加校准剂准备低度和高度QC样品,然后评估短期 (结/解,长板) 和长期 (-80°C) 稳定性,包括血液溶解和高脂血的影响.
主要成果:
- 在EDTA血中确定每个神经生物标志物的度范围.
- 已确定的可接受的试验内和试验间的变化率在±20%以内.
- 在稳定性测试后,聚合的EDTA-血QC样本显示出与名义度的±20%的偏差.
结论:
- 合格的内部程序用于准备QC样本进行神经生物标志物测试.
- 评估EDTA-血QC样品的短期和长期稳定性.
- 验证了这些QC样本在临床试验中用于生物标志物测试的使用.
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