Table 1 Definitions and requirements for standardisation and 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