Part 1: Basic considerations (concepts): Introduction;
Antibody: biochemistry, structure, and function;
Antigen: antibody reactions;
Conjugation techniques;
Antibody production;
Enzymes and signal amplification systems;
Separation and solid phase systems;
Part 2: Product development: Immunoassay classification and commercial technologies;
Assay development, evaluation, and validation;
Reagent formulations and shelf life evaluation;
Data analysis;
Documentation, Registration, and Diagnostic Start-Ups.