{"title":"临床化学测量的不确定性:ISO 20914 与 nordtest 或中间精度与偏差。","authors":"Nilhan Nurlu, Abdulkadir Cat, Kamil Taha Ucar","doi":"10.1080/00365513.2024.2338738","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>Measuring uncertainty (MU) is crucial to ensure the accuracy and precision of laboratory results. This study compares the ISO 20914 and Nordtest guidelines to analyze the MU values for 20 clinical chemistry analytes over six months.</p><p><strong>Methods: </strong>The researchers calculated MU components, including within-laboratory reproducibility (Rw), laboratory analytical performance bias (<i>u</i>(bias)), and combined standard uncertainty (<i>u</i><sub>c</sub>), based on internal quality control and external quality assessment data. The final expanded uncertainty (<i>U</i>) values were determined by multiplying the combined uncertainty with a coverage factor (<i>k</i> = 2 for 95% Confidence Interval), following each guideline's respective procedures. Clinical chemistry analytes were analyzed on Roche Cobas 6000 c501 auto analyzer (Roche Diagnostics, Mannheim, Germany) and manufacturer's kits were used analysis.</p><p><strong>Results: </strong>The results show that 11 out of 20 clinical chemistry analytes met the targeted maximum allowable measurement uncertainty (MAU) values when calculated according to ISO 20914 guideline. Also, 11 out of 20 clinical chemistry analytes' MU values met the MAU values with the Nordtest guideline's recommended calculations. However, some tests met the MAU in the ISO 20914 approach but not in the Nordtest guideline, and vice versa.</p><p><strong>Conclusions: </strong>The study found that intermediate precision (<i>u</i><sub>Rw</sub>) in the ISO 20914 approach and performance bias (<i>u</i>(bias)) in the Nordtest approach significantly impacted MU values. The research highlights the importance of standardization in MU calculation approaches across clinical laboratories. These findings have implications for patient care and clinical decision-making, emphasizing the importance of selecting appropriate laboratory guidelines for routine use.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Measurement uncertainty in clinical chemistry: ISO 20914 versus nordtest or intermediate precision versus bias.\",\"authors\":\"Nilhan Nurlu, Abdulkadir Cat, Kamil Taha Ucar\",\"doi\":\"10.1080/00365513.2024.2338738\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>Measuring uncertainty (MU) is crucial to ensure the accuracy and precision of laboratory results. This study compares the ISO 20914 and Nordtest guidelines to analyze the MU values for 20 clinical chemistry analytes over six months.</p><p><strong>Methods: </strong>The researchers calculated MU components, including within-laboratory reproducibility (Rw), laboratory analytical performance bias (<i>u</i>(bias)), and combined standard uncertainty (<i>u</i><sub>c</sub>), based on internal quality control and external quality assessment data. The final expanded uncertainty (<i>U</i>) values were determined by multiplying the combined uncertainty with a coverage factor (<i>k</i> = 2 for 95% Confidence Interval), following each guideline's respective procedures. Clinical chemistry analytes were analyzed on Roche Cobas 6000 c501 auto analyzer (Roche Diagnostics, Mannheim, Germany) and manufacturer's kits were used analysis.</p><p><strong>Results: </strong>The results show that 11 out of 20 clinical chemistry analytes met the targeted maximum allowable measurement uncertainty (MAU) values when calculated according to ISO 20914 guideline. Also, 11 out of 20 clinical chemistry analytes' MU values met the MAU values with the Nordtest guideline's recommended calculations. However, some tests met the MAU in the ISO 20914 approach but not in the Nordtest guideline, and vice versa.</p><p><strong>Conclusions: </strong>The study found that intermediate precision (<i>u</i><sub>Rw</sub>) in the ISO 20914 approach and performance bias (<i>u</i>(bias)) in the Nordtest approach significantly impacted MU values. The research highlights the importance of standardization in MU calculation approaches across clinical laboratories. 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引用次数: 0
摘要
目的:测量不确定性(MU)对于确保实验室结果的准确性和精确性至关重要。本研究比较了 ISO 20914 和 Nordtest 准则,分析了 20 种临床化学分析物在六个月内的不确定度值:研究人员根据内部质量控制和外部质量评估数据计算了MU的组成部分,包括实验室内重现性(Rw)、实验室分析性能偏差(u(bias))和综合标准不确定度(uc)。最终的扩展不确定度 (U) 值是按照每份指南各自的程序,将综合不确定度乘以覆盖因子(k = 2,95% 置信区间)确定的。使用罗氏 Cobas 6000 c501 自动分析仪(罗氏诊断公司,德国曼海姆)分析临床化学分析物,并使用制造商提供的试剂盒进行分析:结果表明,根据 ISO 20914 准则计算,20 种临床化学分析物中有 11 种达到了最大允许测量不确定度 (MAU) 的目标值。此外,在 20 个临床化学分析项目中,有 11 个项目的 MU 值符合 Nordtest 指南推荐的 MAU 值。然而,有些检测项目在 ISO 20914 方法中符合 MAU 值,但在 Nordtest 指南中却不符合,反之亦然:研究发现,ISO 20914 方法中的中间精度(uRw)和 Nordtest 方法中的性能偏差(u(bias))对 MAU 值有很大影响。这项研究强调了临床实验室MU计算方法标准化的重要性。这些发现对患者护理和临床决策具有重要意义,强调了选择合适的实验室指南作为常规使用的重要性。
Measurement uncertainty in clinical chemistry: ISO 20914 versus nordtest or intermediate precision versus bias.
Aim: Measuring uncertainty (MU) is crucial to ensure the accuracy and precision of laboratory results. This study compares the ISO 20914 and Nordtest guidelines to analyze the MU values for 20 clinical chemistry analytes over six months.
Methods: The researchers calculated MU components, including within-laboratory reproducibility (Rw), laboratory analytical performance bias (u(bias)), and combined standard uncertainty (uc), based on internal quality control and external quality assessment data. The final expanded uncertainty (U) values were determined by multiplying the combined uncertainty with a coverage factor (k = 2 for 95% Confidence Interval), following each guideline's respective procedures. Clinical chemistry analytes were analyzed on Roche Cobas 6000 c501 auto analyzer (Roche Diagnostics, Mannheim, Germany) and manufacturer's kits were used analysis.
Results: The results show that 11 out of 20 clinical chemistry analytes met the targeted maximum allowable measurement uncertainty (MAU) values when calculated according to ISO 20914 guideline. Also, 11 out of 20 clinical chemistry analytes' MU values met the MAU values with the Nordtest guideline's recommended calculations. However, some tests met the MAU in the ISO 20914 approach but not in the Nordtest guideline, and vice versa.
Conclusions: The study found that intermediate precision (uRw) in the ISO 20914 approach and performance bias (u(bias)) in the Nordtest approach significantly impacted MU values. The research highlights the importance of standardization in MU calculation approaches across clinical laboratories. These findings have implications for patient care and clinical decision-making, emphasizing the importance of selecting appropriate laboratory guidelines for routine use.
期刊介绍:
The Scandinavian Journal of Clinical and Laboratory Investigation is an international scientific journal covering clinically oriented biochemical and physiological research. Since the launch of the journal in 1949, it has been a forum for international laboratory medicine, closely related to, and edited by, The Scandinavian Society for Clinical Chemistry.
The journal contains peer-reviewed articles, editorials, invited reviews, and short technical notes, as well as several supplements each year. Supplements consist of monographs, and symposium and congress reports covering subjects within clinical chemistry and clinical physiology.