The enzyme-linked immunosorbent spot (ELISpot) assay is widely recognized as a powerful tool to monitor the immune system in response to therapeutic agents. Specifically, B-cell ELISpot provides information on antigen-specific antibody-secreting cells, including memory B cells. In addition, antigen-specific T-cell responses, most commonly measured by interferon-gamma (IFN-γ), yield valuable insight during clinical studies.
View this webinar to learn how immune monitoring assays, such as ELISpot and intracellular cytokine staining (ICS), provide unique challenges in a regulated environment as no reference material or gold standard is utilized. The FDA Bioanalytical Method Validation (BMV) guidance is not always applicable and may need to be adapted to the unique properties of ELISpot to achieve a fit-for-purpose validation.