Table 1 Definitions and requirements for standardisation and harmonisation
From: The perspective on standardisation and harmonisation: the viewpoint of the EASI president
| Standardisation | Harmonisation | |
|---|---|---|
| Definition | Implementation of a standard preparation in order to maximize compatibility of test results, eventually resulting in uniformity | Adjustment of differences and/or inconsistencies among different measurements, methods and procedures to make them uniform or mutually compatible |
| Requirements | Establishment of an internationally accepted measuring unit as defined by a standard preparation | Consensus on clinical manifestations that warrant the request of the test; to be defined in guidelines |
| Application of the measuring unit in a wide variety of immuno-assays | Consensus on testing algorithms to be used for distinct autoimmune diseases; to be defined in guidelines | |
| Implementation of the standardised measuring unit reveals identical test results in individual samples, independent of the immuno-assay of choice | Consensus on reporting of autoantibody results in combination with test characteristics; to be defined in guidelines | |
| Well-defined composition of the standard preparation in order to guarantee replacement by identical standard preparation | Optimal communication between laboratory specialist and clinician for adequate interpretation of test results |