在临床实验室中定义允许的总误差极限
Jill Palmer1, Kornelia Galior2
1University of Wisconsin Hospital and Clinics, Madison, WI, United States; Unity Point Health-Meriter, Madison, WI, United States.
Advances in clinical chemistry
|January 27, 2024
概括
允许的总误差 (ATE) 定义了实验室分析物的可接受测定极限. 本审查审查了各种ATE资源,并将ATE与观察到的总分析误差 (TAE) 区分开来.
科学领域:
- 临床化学和实验室医学
- 分析毒理学分析毒理学
- 诊断试验开发 诊断试验开发
背景情况:
- 允许的总误差 (ATE) 代表了实验室分析物的关键性能规范限制.
- ATE对于测定验证,患者/仪器数据评估和质量控制策略设计至关重要.
研究的目的:
- 审查和比较各种资源来选择允许的总错误 (ATE).
- 讨论允许总误差 (ATE) 和观察到的总分析误差 (TAE) 之间的区别.
主要方法:
- 审查现有的文献和ATE确定指导方针.
- 对不同的ATE资源进行比较分析,包括法律要求,能力测试,专家组和生物变异.
- 在ATE和观察到的总分析误差 (TAE) 之间的概念差异化.
主要成果:
- 为了选择ATE,存在多种资源,包括法律标准,能力测试 (PT) 和外部质量评估计划 (EQAS),专家共识和生物变异.
- 关于ATE选择的首选来源正在进行讨论.
- 摘要强调了区分预定义的ATE极限和测试的实际观察到的总分析误差 (TAE) 的重要性.
结论:
- 了解和选择适当的ATE对于可靠的实验室测试至关重要.
- 选择ATE资源可以影响测试验收和质量控制.
- 澄清ATE和TAE之间的区别对于准确解释测试性能至关重要.
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