This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request.
NOTE See Annex B for an example of application of the MU.
Status: PublishedPublication date: 2019-07
Edition: 1Number of pages: 73
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
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