Bioanalytical requirements and regulatory guidelines for immunoassays

Immunoassays (IAs) play a prominent role in healthcare and industrial settings to provide an early and precise detection of a single or multiple analytes/biomarker in clinical samples. Such useful and vital information enables healthcare and bioanalytical professionals to take appropriate decisions in a timely manner. Under growing concerns for public health and safety, the regulatory has imposed very stringent bioanalytical requirements for IAs. Although industries and in vitro diagnostic (IVD) manufacturers have obeyed most regulatory requirements, the bioanalytical deficiency of several approved IAs has been increasingly noted. Consequently, the bioanalytical method guidelines must be revised toward the development of IAs with minimal bioanalytical shortcomings. The current trend focuses on the development of medical value IAs using the clinical inputs and the end-user evaluation for each development step. This chapter provides an overview of the bioanalytical requirements for IAs, including the critical advances, technical challenges, and trends in this field.