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White paper: Validating ELISpot for clinical trials

Published: May 7, 2025

1 minute read

Authored by: Tyler Sandberg

ELISpot and FluoroSpot are popular immunoassays for assessing vaccines, cell and gene therapies, and immunotherapies in clinical trials.

These assays are widely used for their sensitivity, robustness, quantitative readouts, and ease of use for individual as well as large-scale testing. Additionally, they are utilized to measure wanted or unwanted immunogenicity from novel therapies and vaccines.

Our white paper explores the applications of both assays and highlights remarkable studies that used these methods. We also cover important validation guidelines and considerations when implementing the assays into your next clinical trial. 

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Precision, LOD, LLOQ, ULOQ, Specificity, Robustness, Linearity Reagent stability, Stability validation steps

The eight main validation parameters to consider for ELISpot and FluoroSpot.


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