Eurachem/CITAC Guide “Assessment of Performance and Uncertainty in Qualitative Chemical Analysis”—A Medical Laboratory Perspective

Standards Pub Date : 2022-05-17 DOI:10.3390/standards2020014
Paulo Pereira
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引用次数: 1

Abstract

Background: The performance assessment of tests that express qualitative results in the medical laboratory is of primary importance in characterization, diagnosis, follow-up, and screening. An important contribution to this type of assessment may be the publication of the Eurachem AQA 2021 guide. The text intends to principally discuss the consistency of the subclauses of this guide with ISO 15189 and CLSI EP12-A2. Methods: The study involves a literature review within the scope of qualitative tests. Results: Tables are used for crossing AQA. with ISO 15189 and CLSI EP12-A2. Conclusions: Consistency with ISO 15189 and CLSI EP12-A2 is demonstrated in the study. Introducing “uncertainty of proportion” reflects the necessity of assessing uncertainties when dealing with qualitative results.
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Eurachem/CITAC指南“定性化学分析的性能和不确定度评估”-医学实验室观点
背景:医学实验室中表达定性结果的测试的性能评估在表征、诊断、随访和筛查中至关重要。对于这类评估的一个重要贡献可能是Eurachem AQA 2021指南的出版。本文旨在主要讨论本指南的子条款与ISO 15189和CLSI EP12-A2的一致性。方法:在定性检验的范围内进行文献综述。结果:采用表法交叉AQA。符合ISO 15189和CLSI EP12-A2标准。结论:本研究符合ISO 15189和CLSI EP12-A2标准。引入“比例不确定性”反映了在处理定性结果时评估不确定性的必要性。
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