Immunoassays: Basic Concepts, Physical Chemistry and Validation

Abstract

Clinical biochemistry teaches that the presence, elevation, or decrease in the concentration of certain proteins or other species in living organisms has a diagnostic function. Thus, the need for rapid, early, and specific analyses of human samples has been the major driving force for the development of appropriate analytical tools. This chapter is meant to give a succinct introduction into the basic mechanisms of immunoassays followed by more detailed information on validation and regulatory aspects. Given the scope of the book, those points that may be of special relevance to emission-based assays are highlighted whenever deemed reasonable. Due to the introductory character of this chapter and limitations in space, there is a clear focus on representative aspects and key issues.