在组装多个实验室和测量系统的医疗保健系统中评估分析性能规范的问题
1Department of Biomedical and Clinical Sciences, Division of Clinical Chemistry and Pharmacology, Linkoping University, Linkoping, Sweden.
Clinical chemistry and laboratory medicine
|February 8, 2024
概括
医疗保健系统可以通过评估多种体外诊断医疗器械 (IVD) 的可重复性来最大限度地降低测量不确定性. 差异组件分析有助于识别导致不确定性的关键因素,改善患者护理.
科学领域:
- 临床化学 临床化学
- 医疗设备的性能 医疗设备的性能
- 医疗保健系统分析 医疗保健系统分析
背景情况:
- 分析性能规范 (APS) 通常与单个体外诊断医疗器械 (IVD MD) 的中间可重现性不确定性进行比较.
- 医疗保健系统经常在各种实验室中使用多个IVDMD,导致患者样本由不同的设备进行分析,有时来自不同的制造商.
研究的目的:
- 评估医疗保健系统内可重现性不确定性的实用性,以尽量减少偏差和整体测量不确定性.
- 探索在多实验室医疗保健环境中量化和最小化测量不确定性的方法.
主要方法:
- 使用根平均平方偏差 (RMSD),计算为样本标准偏差 (SD) 和相对SD,以表达不确定性,包括不准确性和偏差.
- 使用差异成分分析 (VCA) 来量化影响测量不确定性的因素的相对贡献.
- 利用可切换对照样本,分裂患者样本和大数据技术的数据进行偏差和不确定性监测.
主要成果:
- RMSD有效地捕捉不准确性和偏见,使其适合表达医疗保健系统内的不确定性.
- VCA提供了一种方法来识别和量化对测量不确定性的最重要的贡献者.
- 来自对照和患者样本的数据对于监测偏差和测量不确定性至关重要.
结论:
- 在医疗保健系统中评估可重现性不确定性对于开发策略来最大限度地减少偏差和整体测量不确定性是有价值的.
- 差异组件分析为减少测量不确定性提供了关键的见解,最终有利于医疗保健系统内的患者护理.
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