Table 1.

Definitions and requirements for standardisation and harmonisation

	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