Research Topic

Contemporary Challenges in Immunologic Testing in Clinical and Research Laboratories

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Along the last several decades, it has been progressively appreciated that immunology plays an overwhelming role in the physiology and pathophysiology of most organs, tissues, and biological systems in multicellular organisms. Accordingly, several immunological parameters are used in research and clinical ...

Along the last several decades, it has been progressively appreciated that immunology plays an overwhelming role in the physiology and pathophysiology of most organs, tissues, and biological systems in multicellular organisms. Accordingly, several immunological parameters are used in research and clinical laboratories with the purpose of investigating, diagnosing, and monitoring a variety of pathological conditions.

The rapidly evolving field of laboratory testing in immunology poses several challenges to professionals working in research and clinical laboratories, medical practice, educational activities, in vitro diagnostic industry, and regulatory agencies.

Regular analytes, such as albumin, glucose, and insulin, are homogeneous among individuals of the same species. This property represents an advantage when it comes to optimize the determination methods as well as to establish standardization and quality assessment strategies. In contrast, several immunologic analytes present tremendous variability across individuals in the same species. In fact, some are unique at the individual level. For example, the repertoire of immunoglobulins specific for a given pathogen (e.g., rubella) is specific for each individual in terms of the balance of targeted antigens and epitopes, immunoglobulin isotypes, antibody avidity, Fc glycosylation rate, and so on. As a corollary, the panel of anti-rubella antibodies is necessarily different from one to other individual. This also applies to autoantibodies and to IgE to allergens. Polymorphism is prevalent for other immunologic parameters, such as Complement components, cell receptors (cluster differentiation molecules - CD) and downstream signal transduction mediators.

The extreme heterogeneity in some analytes to be determined poses a major challenge for the development of immunoassays, which will necessarily perform differently in different individuals. It also poses challenges in designing strategies for standardization and quality assessment of the immunoassays. The current Covid-19 pandemic remarkably emphasizes these difficulties. Under pressure to develop and commercialize diagnostic kits for determination of anti-SARS-CoV-2 antibodies, the industry worldwide has contributed dozens of different kits using several methodological platforms to determine IgG, IgM or IgA antibodies against strategic peptides of the new coronavirus. Clinical laboratories have rushed in testing and validating kits for the selection of those performing acceptably. Immediately, it became evident that the several kits provided results that were frequently discordant, generating controversy and difficulty in decision making.

In this Research Topic, we welcome the submission of Original Research, Methods, Technology and Code, Review, Mini Review, Systematic Review, Hypothesis and Theory, Classification, and Perspective articles that address the several challenges in standardization and quality assessment of immunologic assays comprehending diverse areas, such as infectious diseases, allergy, autoimmune conditions, cancer and inborn errors of immunity.


We acknowledge the initiation and support of this Research Topic by the International Union of Immunological Societies (IUIS).

Prof. Luis Eduardo Coelho Andrade is chair of the IUIS Quality Assessment and Standardization Committee (QAS), chair of the International Consensus on ANA Patterns (ICAP) and consultant in immunology at Fleury Laboratory.
Prof. Edward Chan is chair of the IUIS Autoantibody Standardization Committee in Rheumatic and Related Disorders and chair of the International Consensus on ANA Patterns (ICAP).
Prof. Pablo Engel is the chair of the IUIS CD Nomenclature Sub-Committee and chair of Quality Assessment and Standardization (QAS) committee on Leukocytes.
Prof. Michael Kirschfink is chair of the IUIS Committee for the Standardization and Quality Assessment of Complement measurements.
Prof. Stefan Vieths is chair of the IUIS Allergen Standardization Sub-Committee.


Keywords: Immunologic Testing, Standardization, Immunoassays, Diagnostic Kits, Immunity


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