Bioanalytical Parameters in Immunoassays and Their Determination

Immunoassays (IAs) play a prominent role in in vitro diagnostics (IVD) of single or multiple analytes in patient samples, a prerequisite for the monitoring and management of health. Stringent bioanalytical testing in parallel with robust statistical analysis stems from the growing concerns for public health and safety. In addition, the prominent role of statistical analysis should adhere to the recent guidelines provided by the regulatory authorities. The guidelines are regularly updated as reflected by continuously evolving technologies and recent trends in IVD and point-of-care testing (POCT). The IA must provide precision, accuracy, high sensitivity, specificity, reproducibility, and robustness. This chapter provides an overview of the critical bioanalytical parameters and their determination, as desired by the regulatory guidelines.