评估用于药理动力学生物标记分析的低容量采样设备:挑战和解决方案
Xiaoyun Yang1, Evelin Logis1, Kathi Williams1
1BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Journal of pharmaceutical and biomedical analysis
|September 1, 2024
概括
低容量血液采样设备对生物标志物分析具有前景,Mitra和Tasso设备在解决测量干扰后,与可溶性粘膜地址细胞粘附分子1 (sMAdCAM-1) 测量血清一致.
科学领域:
- 生物标记分析 生物标记分析
- 临床诊断 临床诊断 临床诊断
- 药理动力学 药理动力学
背景情况:
- 低体积采样 (LVS) 技术为血液采集提供了最少侵入性的替代方案.
- 这些方法提高了患者的舒适性,扩大了人口的多样性,并支持分散的临床试验.
- 测量生物标志物,如可溶性粘膜地址细胞粘附分子1 (sMAdCAM-1),对于治疗监测至关重要.
研究的目的:
- 为了验证Gyrolab对LVS设备的干血样本中的sMAdCAM-1的测定.
- 将Mitra,Tasso-M20和Tasso-One Plus设备中的sMAdCAM-1测量结果与血清进行比较.
- 评估LVS采集方法对生物标志物测定性能的影响.
主要方法:
- 来自Mitra和Tasso-M20设备的干血斑点 (DBS) 中sMAdCAM-1的Gyrolab测定验证.
- 概念验证研究将Mitra,Tasso-M20和Tasso-One Plus与静脉穿刺血清进行比较.
- 使用 Quanterix Simoa 试验减轻干扰,以提高稀释样品的灵敏度.
主要成果:
- 最初的Gyrolab测定显示了Mitra和Tasso-M20 DBS中的提取缓冲器的干扰,导致sMAdCAM-1度更高.
- 为了减轻干扰的稀释对 Gyrolab.com 的sMAdCAM-1检测能力产生了负面影响.
- 昆特里克斯Simoa测定最小化了稀释样本的干扰,显示Mitra DBS,Tasso-M20 DBS和Tasso-One Plus液体血液与血清的良好一致性.
- 在Mitra DBS中发现了一个偏差,可能是由于不同的收集站点.
结论:
- 对于sMAdCAM-1生物标志物分析,LVS技术是可行的,特别是在使用诸如Quanterix Simoa等敏感测试时.
- 仔细考虑测试干扰和样本矩阵效应对于LVS实施至关重要.
- 在广泛整合临床研究之前,了解LVS设备的局限性至关重要.
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