Abstract

Enzyme immunoassays are based on antigen-antibody reactions involving enzyme-labeled antigen (or antibody) with antibody (or antigen). An understanding of the fundamentals of antigen-antibody reactions is, therefore, essential for the success of a product development process based on this technology. In the diagnostic industry, antigens represent an extremely diverse spectrum of compounds ranging from simple haptens to macromolecules such as proteins, microorganisms and viruses. In this section, the fundamental aspects of the antigen-antibody reactions are covered only from a process development viewpoint. Wherever possible, references are cited that deal with detailed theoretical, mathematical, and biochemical treatment of this subject.

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