一种新的方法,用于例行评估实验室Sigma指标,用于广泛的自动化测试
Johanna J Miller1, Alistair J Gammie2
1Automation and Portfolio Solutions, QuidelOrtho Corporation, Rochester, NY, United States.
The journal of applied laboratory medicine
|February 23, 2024
概括
临床实验室Sigma指标评估测试性能,较高的水平表明更好的质量. 这项研究发现,大多数测试都达到高西格玛水平,即使有现实世界的变化,也证明了质量评估的强有力的方法.
科学领域:
- 临床化学 临床化学
- 实验室质量管理的质量管理.
- 测试绩效评价 测试绩效评价
背景情况:
- 西格玛指标在临床实验室中用于评估基于准确性,精度和允许总误差的测试性能.
- 更高的Sigma指标值意味着更高的工艺性能.
- 之前的研究经常在有限的,高度控制的系统上评估西格玛指标.
研究的目的:
- 开发和验证一种方法,在多个临床实验室系统中为众多分析物推导单一的Sigma指标.
- 用Sigma指标评估实验室临床试验在现实环境中的性能.
主要方法:
- 创建了一个算法,从QuidelOrtho E-Connectivity®数据库中提取115个分析物的质量控制 (QC) 数据.
- 用提取的QC数据计算了每个分析物的Sigma指标.
- 对于每个测试,确定了SIGMA指标的中位数,以代表整体性能.
主要成果:
- 在115个分析试验中,79个 (68.7%) 获得了6或更高的Sigma指标.
- 在115个分析试验中,共有98个 (85.2%) 达到5或更高的Sigma指标.
- 尽管实验室和仪器具有固有的变异性,但仍观察到这些高的Sigma水平.
结论:
- 建立了一种新的方法,将数百个分析仪的Sigma指标整合到一个单一的测试质量指标中.
- 这种方法为了解在各种实验室条件下测试性能提供了基线.
- 该研究强调,大多数试验都显示出高西格玛性能,即使考虑到实验室环境,仪器仪表,材料和试剂的变化.
相关概念视频
01:15Data Validation
162
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
Key parameters for method validation include:
162
01:11Statistical Analysis: Overview
6.6K
When we take repeated measurements on the same or replicated samples, we will observe inconsistencies in the magnitude. These inconsistencies are called errors. To categorize and characterize these results and their errors, the researcher can use statistical analysis to determine the quality of the measurements and/or suitability of the methods.
One of the most commonly used statistical quantifiers is the mean, which is the ratio between the sum of the numerical values of all results and the...
One of the most commonly used statistical quantifiers is the mean, which is the ratio between the sum of the numerical values of all results and the...
6.6K