Evaluation of measurement uncertainty results calculated by two different methods and total analytical error for ethanol testing.

IF 1.5 4区 医学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY
Mehmet Akif Bozdayi, İsmet Gamze Bozdayı, Gökhan Çakırca
{"title":"Evaluation of measurement uncertainty results calculated by two different methods and total analytical error for ethanol testing.","authors":"Mehmet Akif Bozdayi, İsmet Gamze Bozdayı, Gökhan Çakırca","doi":"10.5937/jomb0-55093","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The analytical performance metrics of ethanol testing are critically important due to their legal implications when presenting and interpreting results. Measurement uncertainty (MU) and total analytical error (TAE) are essential approaches for evaluating and improving the quality of measurement procedures. This study aimed to calculate MU and TAE values, which assess the reliability of ethanol test results from different perspectives, and to evaluate the impact of MU values, calculated using two different methods, on the legal threshold.</p><p><strong>Methods: </strong>MU values were calculated following the guidelines of Nordtest and ISO/TS 20914. TAE was determined using the formula TAE%=1.65×CV%+Bias%. External and internal quality data from ethanol testing conducted between July 1, 2022, and June 30, 2024, were used for calculations.</p><p><strong>Results: </strong>The expanded MU values for ethanol testing were 13.95% according to the Nordtest Guide, 10.94% for low level and 9.59% for high level according to the ISO/TS 20914 Guide. The calculated TAE values were 12.59 for low levels, 11.47 for high levels, and 12.57 overall. MU and TAE values for ethanol testing in our laboratory remained within the allowable total error (±20%) according to CLIA 2024.</p><p><strong>Conclusions: </strong>We believe each laboratory should report ethanol test results and their respective MU values, particularly when evaluating results close to legal thresholds. Furthermore, we suggest that scientific committees standardise the method for calculating MU and define a target limit.</p>","PeriodicalId":16175,"journal":{"name":"Journal of Medical Biochemistry","volume":"44 4","pages":"808-813"},"PeriodicalIF":1.5000,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12363359/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Medical Biochemistry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5937/jomb0-55093","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: The analytical performance metrics of ethanol testing are critically important due to their legal implications when presenting and interpreting results. Measurement uncertainty (MU) and total analytical error (TAE) are essential approaches for evaluating and improving the quality of measurement procedures. This study aimed to calculate MU and TAE values, which assess the reliability of ethanol test results from different perspectives, and to evaluate the impact of MU values, calculated using two different methods, on the legal threshold.

Methods: MU values were calculated following the guidelines of Nordtest and ISO/TS 20914. TAE was determined using the formula TAE%=1.65×CV%+Bias%. External and internal quality data from ethanol testing conducted between July 1, 2022, and June 30, 2024, were used for calculations.

Results: The expanded MU values for ethanol testing were 13.95% according to the Nordtest Guide, 10.94% for low level and 9.59% for high level according to the ISO/TS 20914 Guide. The calculated TAE values were 12.59 for low levels, 11.47 for high levels, and 12.57 overall. MU and TAE values for ethanol testing in our laboratory remained within the allowable total error (±20%) according to CLIA 2024.

Conclusions: We believe each laboratory should report ethanol test results and their respective MU values, particularly when evaluating results close to legal thresholds. Furthermore, we suggest that scientific committees standardise the method for calculating MU and define a target limit.

乙醇试验中两种不同方法计算的测量不确定度结果及总分析误差评定。
背景:乙醇测试的分析性能指标是至关重要的,因为它们在呈现和解释结果时具有法律意义。测量不确定度(MU)和总分析误差(TAE)是评价和提高测量过程质量的重要方法。本研究旨在计算从不同角度评估乙醇试验结果可靠性的MU和TAE值,并评估采用两种不同方法计算的MU值对法定阈值的影响。方法:按照Nordtest和ISO/TS 20914标准计算MU值。TAE的计算公式为TAE%=1.65×CV%+Bias%。在2022年7月1日至2024年6月30日期间进行的乙醇测试的外部和内部质量数据用于计算。结果:乙醇检测的扩展MU值按Nordtest指南为13.95%,按ISO/TS 20914指南为10.94%,按ISO/TS 20914指南为9.59%。计算的TAE值为低水平12.59,高水平11.47,总体12.57。本实验室乙醇检测的MU和TAE值均在CLIA 2024允许的总误差(±20%)范围内。结论:我们认为每个实验室都应该报告乙醇测试结果及其各自的MU值,特别是在评估接近法定阈值的结果时。此外,我们建议科学委员会对MU的计算方法进行标准化,并确定目标限值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Journal of Medical Biochemistry
Journal of Medical Biochemistry BIOCHEMISTRY & MOLECULAR BIOLOGY-
CiteScore
3.00
自引率
12.00%
发文量
60
审稿时长
>12 weeks
期刊介绍: The JOURNAL OF MEDICAL BIOCHEMISTRY (J MED BIOCHEM) is the official journal of the Society of Medical Biochemists of Serbia with international peer-review. Papers are independently reviewed by at least two reviewers selected by the Editors as Blind Peer Reviews. The Journal of Medical Biochemistry is published quarterly. The Journal publishes original scientific and specialized articles on all aspects of clinical and medical biochemistry, molecular medicine, clinical hematology and coagulation, clinical immunology and autoimmunity, clinical microbiology, virology, clinical genomics and molecular biology, genetic epidemiology, drug measurement, evaluation of diagnostic markers, new reagents and laboratory equipment, reference materials and methods, reference values, laboratory organization, automation, quality control, clinical metrology, all related scientific disciplines where chemistry, biochemistry, molecular biology and immunochemistry deal with the study of normal and pathologic processes in human beings.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信