Mehmet Akif Bozdayi, İsmet Gamze Bozdayı, Gökhan Çakırca
{"title":"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。","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":"{\"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}","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}
Evaluation of measurement uncertainty results calculated by two different methods and total analytical error for ethanol testing.
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.
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.