在临床常规实验室使用验证数据计算初步测量不确定性值的方法
Simon Michaelis1, Laura Binder1, Christopher Schneider1
1Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Vordernberger Straße 42, 8700 Leoben, Austria.
Clinica chimica acta; international journal of clinical chemistry
|September 13, 2025
概括
估计测量不确定性 (MU) 对临床实验室至关重要. 这项研究表明,验证数据为初步的MU计算提供了可行的方法,有助于ISO 15189认证.
科学领域:
- 临床化学 临床化学
- 实验室质量管理的质量管理.
- 计量学 计量学 计量学
背景情况:
- 测量不确定性 (MU) 对临床实验室质量和ISO 15189认证至关重要.
- 目前关于建立MU缺乏共识,需要对替代方法进行评估.
- 本研究探讨使用现有的验证数据进行初步的MU估计.
研究的目的:
- 评估计算初步测量不确定性 (MU) 的程序.
- 为了比较来自内部质量控制 (IQC) 数据和验证数据的MU估计.
- 评估验证数据是否适合在常规临床实验室初步确定MU.
主要方法:
- 使用Nordtest协议计算了29个测量项的扩展测量不确定性 (U).
- 使用了两个数据集:内部质量控制 (IQC) 数据和验证数据 (CLSI EP15-A3).
- 将计算的MU值 (MUIQC和MU验证) 与已建立的接受标准 (Rili-BAEK,Westgard) 进行比较.
主要成果:
- 来自IQC数据的MU值通常高于来自验证数据的MU值.
- MUIQC和MU验证之间的差异 (ΔU) 不同,一些测量值显示出显著差异.
- 所有计算的MU值,无论数据来源如何,都符合Rili-BAEK和Westgard的接受标准.
结论:
- 验证数据为在临床环境中估计初步测量不确定性提供了合适的方法.
- 这种方法可以帮助实验室满足质量标准和认证要求.
- 进一步验证可能会提高使用验证数据的MU估计的可靠性.
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