在可追溯时代建立,评估和监测分析质量
Mauro Panteghini1, Magdalena Krintus1
1Department of Laboratory Medicine, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Bydgoszcz, Torun, Poland.
Critical reviews in clinical laboratory sciences
|January 1, 2025
概括
实现协调的实验室结果需要建立计量可追溯性和估计测量不确定性. 这确保了医学测试的准确解释和患者的安全,这是所有利益相关者的关键目标.
科学领域:
- 实验室医学 实验室医学
- 分析化学 分析化学
- 计量学 计量学 计量学
背景情况:
- 实验室测试中的分析质量差导致了医学诊断和患者护理方面的重大挑战.
- 使用各种体外诊断 (IVD) 设备的不同实验室的结果的变化可能会导致误解和伤害.
- 实验室测量的协调对于可靠的患者管理至关重要.
研究的目的:
- 审查建立,评估和监测实验室医学分析质量的策略.
- 讨论影响分析标准化的因素,并提供实际解决方案.
- 强调利益相关者之间合作的必要性,以获得协调的结果.
主要方法:
- 基于丰富的经验,对分析质量管理策略的审查.
- 关于计量可追溯性和测量不确定性 (MU) 估计的讨论.
- 与国际推模型相比,MU预算的验证.
主要成果:
- 协调要求对更高层次的参考和MU估计进行计量追溯.
- 一个全面的MU预算,根据适合用途的限制进行验证,至关重要.
- 实际解决方案和利益相关者教育是实现标准化的关键.
结论:
- 建立计量可追溯性和估计测量不确定性对于协调实验室结果至关重要.
- 参考提供商,IVD制造商,实验室和EQA之间的合作是必要的.
- 加强各方之间的知识和协议对于实施推方法至关重要.
更多相关视频
08:56Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry
Published on: November 22, 2024
556
11:00Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry UPLC-HRMS
Published on: May 20, 2013
22.4K
相关概念视频
Quality Control
150
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
150
Quality Assurance
115
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
115
Data Validation
141
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:
141
Development of Analytical Methods
373
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
373
Quantitative Analysis
244
Quantitative analysis is a technique for measuring the amount of specific constituents in a sample. When the sample's composition is unknown, qualitative analysis is performed first to identify its components, which ensures that the correct substances are measured during the quantitative phase.
In quantitative analysis, two key measurements are made: the sample quantity and a property proportional to the amount of the analyte (the substance being analyzed). This forms the basis of the...
In quantitative analysis, two key measurements are made: the sample quantity and a property proportional to the amount of the analyte (the substance being analyzed). This forms the basis of the...
244
Qualitative Analysis
215
Qualitative analysis is the process of identifying elements, ions, or compounds in an unknown sample. It is the first and most fundamental type of analysis based on the hierarchy of analytical goals. This hierarchy is significant as it provides a structured approach to scientific research, with qualitative analysis serving as the initial step, providing essential information before moving on to quantitative or other forms of analysis.
There are two main approaches to qualitative analysis:...
There are two main approaches to qualitative analysis:...
215
