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在标准化时代的外部质量保证
Elvar Theodorsson1, Piet Meijer2, Tony Badrick3
1Department of Biomedical and Clinical Sciences, Division of Clinical Chemistry and Pharmacology, Linköping University, Linköping, Sweden.
概括
外部质量评估 (EQA) 和计量可追溯性对于确保准确的临床化学测量至关重要. 本研讨会摘要强调了它们在验证体外诊断测量设备和实现可靠的患者结果方面的相互关联作用.
科学领域:
- 临床化学 临床化学
- 计量学 计量学 计量学
- 实验室医学 实验室医学
背景情况:
- 临床化学中的计量学确保了在体外诊断测量设备 (IVD MD) 中测量结果的等价性.
- 对更高阶参考的计量可追溯性对于结果等价性至关重要.
- 参考材料和外部质量评估 (EQA) 材料的可交换性对于最终用户的监测至关重要.
研究的目的:
- 总结实验室医学中可追溯性联合社区 (JCTLM) 关于实验室医学计量学的研讨会的发现.
- 探索EQA/技能测试与计量可追溯性之间的关系.
- 讨论EQA在维护IVDMD测量结果等价性方面的作用.
主要方法:
- 在2023年12月4日至5日举行的JCTLM研讨会的讨论和意见摘要.
- 探索EQA和计量可追溯性之间的相互作用.
- 对临床适用性的分析性能规范 (APS) 的讨论.
主要成果:
- EQA监测终端用户IVDMD的测量结果的等价性.
- 讨论了EQA在改善和保持测量结果等价性方面的挑战和作用.
- 通过APS阐明了通过实验室结果确定临床适用性的当前发展.
结论:
- 计量可追溯性和EQA的整合对于可靠的临床化学测量至关重要.
- 有效的EQA策略是必要的,以确保IVDMDs的持续等价性.
- 建立分析性能规范是确保实验室结果临床实用性的关键.
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