基于结果的分析性能规范:当前状态和未来的挑战
Andrea Rita Horvath1,2,3, Katy J L Bell4, Ferruccio Ceriotti5
1Department of Chemical Pathology, 441551 New South Wales Health Pathology, Prince of Wales Hospital , Sydney, Australia.
Clinical chemistry and laboratory medicine
|June 5, 2024
概括
定义分析性能规范 (APS) 首先需要了解临床需求. 本研究探讨基于结果的APS方法,重点关注临床性能要求和实验室测试可接受的错误分类率.
科学领域:
- * * 临床化学 临床化学
- * 实验室医学 实验室医学
- * 医学诊断 医学诊断 医学诊断
背景情况:
- *分析性能规范 (APS) 对于确保实验室测试通过超过潜在危害对患者有益至关重要.
- *在没有首先建立与患者管理相关的临床性能要求的情况下,定义分析性能是具有挑战性的.
- * 实验室检测,临床决定和患者健康结果之间的联系需要基于结果的APS.
研究的目的:
- *讨论基于结果的分析性能规范 (APS) 的关键定义,概念和考虑因素,特别是模型1b.
- * 审查现有的推导模型1b APS的方法,评估它们的优势,局限性和可转移性.
- * 为系统地定义临床性能要求和解决基于结果的APS未来挑战提供指导.
主要方法:
- * 基于临床结果推导模型1b APS的已发表方法的审查.
- *讨论用于评估分析性能对临床结果的影响的基于模拟的研究.
- *对模型1b APS在不同环境中的可转移性标准的分析.
主要成果:
- *对临床上可接受的错误分类率的定义是推导模型1b APS的核心.
- *模拟研究经常用于将分析性能与临床结果概率联系起来.
- * 模型1b APS的可转让性取决于具体的标准和设置考虑因素.
结论:
- * 建立临床性能要求是定义适当的基于结果的APS的先决条件.
- * 需要一个系统的方法来定义实验室试验的临床性能要求.
- *需要进行进一步的研究,以应对为实验室测试提供基于结果的APS的挑战.
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