Standardization of autoimmune testing - is it feasible?

Correct measurement of autoantibodies is essential for the diagnosis of autoimmune diseases. However, due to the variability of autoantibody results and the heterogeneity of testing, wrong diagnosis is a reality. For this and more reasons, harmonization of testing is of the out-most importance. In this review we have summarized the factors contributing to this variability. The ways with which the working group on harmonization of autoantibody testing of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has been trying to tackle the issue with the production and correct use of certified reference materials (CRMs), is discussed. Finally the advantages and the limitations of the use of CRMs are presented.