对三种CRM进行交换性研究,评估它们适用于校准,准确性验证和测量人类血液中金属度的统计质量控制方法的适用性
Thomas P J Linsinger1, Guy Auclair2, Liesbet Deprez2
1Joint Research Centre, European Commission, Retieseweg 111, 2440, Geel, Belgium. thomas.linsinger@ec.europa.eu.
Analytical and bioanalytical chemistry
|February 4, 2025
概括
这项研究评估了血液中重金属的认证参考材料,发现目前的可交换性标准过于严格. 放松标准表明材料适用于校准器和质量控制.
科学领域:
- 分析化学 分析化学
- 环境科学 环境科学
- 临床化学 临床化学
背景情况:
- 认证参考材料 (CRM) 对于血液中准确的重金属分析至关重要.
- 可交换性确保CRM在分析过程中表现得像患者样本.
研究的目的:
- 为了评估三个血液CRM的Cd,Cr,Hg,Ni,Pb和Tl的可交换性.
- 评估非可换性偏差对测量不确定性和适合质量控制的影响.
主要方法:
- 偏差方法的差异比较消化ICP-MS与稀释ICP-MS或GFAAS.
- 最大非可交换性偏差 (MANCB) 取自能力测试提供商的容忍限度.
主要成果:
- 目前的通用性标准过于严格,需要过度测量或更大的MANCB.
- 增加的MANCB对可容忍的测量不确定性产生了小到中等的影响,表明对校准器使用的可切换性.
- 包括非可交换性不确定性在内的整体测量不确定性最小增加.
- CRM偏差通常在患者样本偏差置信限范围内,支持其在质量控制中的使用.
结论:
- 评估的CRM适用于血液重金属分析中的真实性控制,方法验证和统计质量控制.
- 调整 MANCB 标准是必要的,以便在实践中评估通用性.
- 当CRMs作为校准器使用时,它们表现出可靠的性能.
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