Immunoassays have multiple target parameters for desirable performance and multiple input (control) variables. The relationships between input and target variables may be linear or non-linear, and input variables may interact. This chapter provides an overview of immunoassay development in industry with a focus on the use of computerized Design of Experiments techniques to optimize performance by understanding the relationships between the multiple variables.

Dr. Doug Brandt is Director of Consulting at ProChain Solutions, Inc., previously at Abbott Diagnostics for 22 years.

Steve Figard is Director of Research at Bob Jones University. He worked for Abbott Diagnostics for 26 years.

Immunoassay design, customer needs, experimental design, design of experiments, experimental error, dependent responses, independent controls, resolving power, clinical specificity, clinical sensitivity.