临床实验室允许总错误的概述
Michelle R Campbell1, Kornelia Galior2
1Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States.
The journal of applied laboratory medicine
|November 11, 2025
概括
允许的总误差 (ATE) 定义了临床实验室试验的可接受分析性能. 在确定ATE接受标准之前,了解各种资源及其局限性至关重要.
科学领域:
- 临床实验室科学 临床实验室科学
- 分析化学 分析化学
- 医疗保健中的质量管理
背景情况:
- 允许总误差 (ATE) 是临床实验室试验的关键质量指标,确保可接受的分析性能.
- 根据具体的测定,测试环境和临床应用,ATE的限值会有所不同.
- ATE在临床实验室中经常用于方法评估,质量控制故障排除和仪器比较.
研究的目的:
- 审查和描述各种资源,以确定临床实验室测试中的允许总误差 (ATE) 极限.
- 讨论与设定ATE的不同方法相关的优点和弱点.
- 为了让用户了解不同的定义方法导致的ATE大小的变化.
主要方法:
- 对设定可允许总误差 (ATE) 的资源的文献综述.
- 分析方法包括临床结果,生物变异,最新技术,专业指南和监管要求.
- 讨论每个资源的优势和局限性.
主要成果:
- 没有普遍标准来定义最大允许误差.
- 可以使用多种资源 (临床结果,生物变异,最先进的技术,专业组织,监管机构) 来设定ATE.
- 每个资源在相同的测试中产生不同的ATE大小.
结论:
- 用户必须了解用于设置ATE的各种可用的资源.
- 了解每个资源的局限性在建立实验室测定验收标准之前至关重要.
- 根据ATE资源的知情选择,可以确保适当的分析性能标准.
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