Contemporary Challenges in Immunologic Testing in Clinical and Research Laboratories

Book excerpt: 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.