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

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.