DEVELOPMENTS IN IMMUNOLOGICAL STANDARDIZATION

In the century since Paul Erlich's innovative immunological standardiz ation work with diphtheria anti-toxin, the field of immunological stan dardization has expanded dramatically. Biological standards for a dive rse range of immunological substances have been produced e.g. immunogl obulins, complement components, autoantibodies and blood group reagent s. The concept of calibration of such materials in biological units of potency is now widely accepted for many such substances. Most recentl y much effort has been devoted to producing biological standards for c ytokines which can be used to calibrate and validate biological assays for these analytes. Immunoassays have been found to be particularly p roblematical from the standardization view point although provision of a single international standard for distribution world-wide is clearl y advantageous and helps reduce assay variability. It is hoped that th e considerable progress with immunological standardization achieved du ring the past century will continue and expand to ensure the validity of existing and new immunological assays which will be required in the future. (C) 1998 Elsevier Science B.V. All rights reserved.