支持更高层次的参考提供商的优先级工作,使用来自实验室医学可追溯性联合委员会数据库的证据
Mauro Panteghini1, Robert Wielgosz2
1Department of Laboratory Medicine, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Torun, Poland.
Clinical chemistry and laboratory medicine
|April 10, 2025
概括
实验室医学可追溯性联合委员会 (JCTLM) 数据库帮助IVD制造商和实验室专业人员. 供应商必须紧急提供关键分析物的更高层次参考资料 (CRM/RMP),以满足质量标准.
科学领域:
- 实验室医学 实验室医学
- 计量学 计量学 计量学
- 分析化学 分析化学
背景情况:
- 实验室医学中可追溯性联合委员会 (JCTLM) 数据库对于实验室医学中的计量可追溯性至关重要.
- 主要用户包括IVD制造商,实验室专业人员和CRM/RMP提供商.
- 本报告侧重于JCTLM数据库信息对CRM和RMP提供商的有用性.
研究的目的:
- 评估 JCTLM 数据库信息对更高级认证参考材料 (CRM) 和参考测量程序 (RMP) 提供商的有用性.
- 找出关于CRM和RMP的当前JCTLM数据库产品中的差距.
- 为改善更高层次参考资料的可用性和质量提供建议.
主要方法:
- 分析与CRM和RMP提供商相关的JCTLM数据库内容.
- 评估使用列出的CRM作为校准器的使用情况.
- 评估CRM值和RMP可重复性的测量不确定性 (MU),以及它们对临床样本MU相对于最大允许MU (MAU) 的影响.
主要成果:
- 该 JCTLM 数据库为IVD制造商和实验室专业人员提供了有价值的信息.
- 对于几个关键分析品,需要更多更高层次的参考资料 (CRM和/或RMP).
- 当前的参考文献往往缺乏足够的交换性评估,对MAU履行的贡献,或证明的等价性.
结论:
- CRM和RMP供应商必须紧急解决缺乏关键分析物的更高层次参考.
- 对于现有和新的引用,需要改进可换性评估,对MAU的贡献和证明的等价性.
- 将JCTLM数据库增强为有关更高级参考的全面信息,将改善实验室医学中的计量可追溯性.
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