The importance of standardization in immunology in clinical and research scenarios
Luis Eduardo C. Andrade, MD, PhD
Universidade Federal de São Paulo, Brazil
Chair of the IUIS Quality Assessment and Standardization Committee
Standardization is a crucial issue in any area related to quantification of natural phenomena. The standardization process involves the establishment of standards developed by consensus among interested parties. Standardization is important for promoting compatibility, repeatability, interoperability, quality and safety. The standardization activity is present in ancient civilizations, as demonstrated by archeological artifacts and historical documentation referent to standards for weight, length, time, volume, etc. With the industrial revolution and increment of international transactions, the standardization business progressively became more necessary and effective. In general, there is a direct correlation between the degree of advancement in a given field and the level of standardization in the respective parameters.
In the immunology field, standardization is not a problem for parameters expressed on usual international units for mass, volume, molar concentration, and so on. In contrast, several immunological phenomena are classified and quantified in non-orthodox ways. For example, the intensity of antibody reactivity of a serum sample against a given antigen is usually expressed as arbitrary units defined by the manufacturers of that specific assay. The same applies for some assays to determine serum complement activity and to determine IgE antibodies against specific allergens. When one considers the flourishing and heterogeneous field of diagnostic reagent companies worldwide, it becomes clear that clinical laboratories may issue non-equivalent results for the same sample depending on the commercial reagents used for the assays. The same applies to research laboratories. Therefore, standardization in immunology may affect directly clinical decisions made on the basis of laboratory test results as well as the interpretation of data from scientific communications.
The need for standardization in immunological assays has been addressed by the International Union of Immunology Societies (IUIS) by the establishment of the Quality Assessment and Standardization (QAS) Committee almost two decades ago. This Committee has been successfully chaired for 15 years by Professor Rudolf Valenta, from University of Vienna, followed by Professor Fatima Ferreira, from the University of Salzburg, in the last two years. The QAS Committee operates through six Subcommittees (Table 1), aiming to promoting and strengthening standardization and quality assessment in immunological assays, publicizing the activities of each subcommittee, and attracting sponsorship for activities related to international QAS in immunology.
Table 1 – Subcommittees for Quality Assessment and Standardization
| Subcommittee | Chair | Website |
| Subcommittee for Standardization of Autoantibodies in Rheumatic and Related Diseases (Autoantibody Standardization Committee) |
Edward K.L. Chan (USA) |
www.ANApatterns.org |
| Sub‐Committee on Leukocytes |
Pablo Engel (Spain) |
www.hcdm.org |
| Sub‐Committee on Allergen Standardization |
Stefan Vieths (Germany) |
www.allergen.org/standard.php |
| Sub-Committee for the standardization and quality assessment of complement measurements |
Michael Kirschfink (Germany) |
www.complement.org/committee |
| Subcommittee for the Standardization and Quality Assessment in Immunotherapy |
Clemens Scheinecker (Austria) |
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| Sub‐Committee on Organ-Specific Autoantibodies |
Alberto Falorni (Italy) |
