Method validation is a prerequisite for all methods/equipment involved in processing patient results. This is to guarantee the validity of test results in a medical laboratory. As a rule, the method/equipment developer conducts validation. However, laboratories are required to conduct independent verification of, and validate methods to confirm that the method/equipment can produce the intended results.
Measurement uncertainty on the other hand represents the doubt associated with test results due analytical and non-analytic factors that affects measurements in the laboratory. As rule, laboratory measurements provide a best estimate of a quantity of interest (such as Blood glucose test value or therapeutic drug measurements). Because these are estimates, there is always some uncertainty about how closely they represent the true value of the quantity. This forms the basis the for estimation of Measurement Uncertainty (MU). It is essential to account for measurement uncertainty to enable healthcare givers to determine the clinical significance of a test result value given the analytical factors that may have an influence on it.
Metrological traceability is used as the basis the for comparability of test results across different, methods/equipment and locations.
