This chapter describes and explains the primary parameters used to evaluate immunoassay performance. These test the fundamental immunoassay characteristics, such as sensitivity, specificity, accuracy and precision, and performance measures related to immunoassay application, such as method comparison.

This chapter is based on material in earlier editions of The Immunoassay Handbook written by Chris Davies, formerly Scientific Advisor at Ortho Clinical Diagnostics, and more recently, International Project Manager for Biotechnology at the Welsh Development Agency. He is currently the Business Development Manager for Life Sciences for the Welsh Government. Chris has achieved global recognition for his ability to explain immunoassay principles through his chapters in The Immunoassay Handbook.

Sensitivity, analytical sensitivity, functional sensitivity, specificity, cross-reactivity, interference, accuracy, bias, precision, imprecision, precision profile, edge effects, minimal distinguishable difference in concentration, relative potency, high-dose hook effect, recovery, dilution, correlation, method comparison, linear regression, Deming regression, assay drift.