New Guides for Uncertainty of Qualitative Results

The Journal of Applied Laboratory Medicine 8(1):217-218

https://doi.org/10.1093/jalm/jfac087

• Project: 
• Accreditamento laboratori medici

The Eurachem/Cooperation on International Traceability in Analytical Chemistry (CITAC) guide “Evaluating Performance and Uncertainty in Qualitative Chemical Analysis” has recently been published (1).

a number of criticisms of the guide have recently been reported, including the lack of the repeatability and reproducibility components for the accuracy of the methods (2).

 the International Organization for Standardization (ISO) has published ISO/TR 27877, which is devoted properly to statistical analysis for evaluating the precision of binary measurement methods and their results (3).

The approach for medical laboratories should be simple, low burden, as designed by ISO 20914, but inclusive of qualitative tests (tests with nominal results), and tests with ordinal results alongside numerical results of the internal response signal(s).