参考范围 (ReferenceRangeR):一个新的工具,旨在促进参考区间的估计和验证
Gunnar Brandhorst1, Maike Voß1, Werner Wosniok2
1Institute for Clinical Chemistry and Laboratory Medicine, University Medicine Oldenburg, Oldenburg, Germany.
Clinical chemistry and laboratory medicine
|October 22, 2025
概括
一个新的基于网络的应用程序,ReferenceRangeR,简化了使用真实数据估计和验证实验室参考间隔 (RI). 该工具使实验室专业人员能够满足监管标准,而不需要专门的统计或技术专业知识.
科学领域:
- 临床化学 临床化学
- 实验室医学 实验室医学
- 生物信息学是一种生物信息学.
背景情况:
- 参考间隔 (RIs) 对于准确的实验室测试解释至关重要.
- 建立和审查实验室特定的RI是监管要求.
- 直接的RI确定方法通常是不切实际的,而间接的方法需要专门的专业知识.
研究的目的:
- 开发一个用户友好的Web应用程序,用于估计和验证参考间隔.
- 为缺乏统计或技术专业知识的实验室提供一个可访问的工具.
- 为了促进对参考区间建立的现行监管标准的遵守.
主要方法:
- 使用R Studio和Shiny框架开发一个Web应用程序.
- 整合了五种间接方法来估计参考区间 (refineR,TMC,TML,cosmic,reflimR).
- 实施Docker容器以确保本地部署的安全性,以及用于基于年龄的分层分析的漂移检测算法.
主要成果:
- 该应用程序可以通过复制粘贴接收多达20万个实验室测试结果.
- 它为基于性别的分层提供了基于数据的建议,并分析了基于年龄的分层的必要性.
- 结果可视化,并且可以根据计算的间隔验证现有的RI.
结论:
- 参考范围 (ReferenceRangeR) 是一个可访问,用户友好的工具,用于估计和验证RI.
- 它消除了对专门的统计或技术专业知识的需求.
- 该工具支持实验室专业人员遵守RI的监管要求.
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