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Recommendations on ELISpot Assay Validation by the GCC

2022; Future Science Ltd; Volume: 14; Issue: 4 Linguagem: Inglês

10.4155/bio-2022-0010

1757-6199

Rafiq Islam, Jennifer Vance, Martin Poirier, Jennifer Zimmer, Ardeshir Khadang, Dave Williams, Jennifer Zemo, Todd Lester, Marianne Scheel Fjording, Amanda Hays, Nicola Hughes, Fabio Garofolo, Curtis Sheldon, Rudolf Guilbaud, Christina Satterwhite, Kelly Colletti, Elizabeth Groeber, Heidi Renfrew, Mathilde Yu, Jenny Lin, Xinping Fang, Mark Wissel, Thomas C. Beadnell, John Lin, Santosh Shah, Wei Garofolo, Natasha Savoie, Richard B. Hayes, John Pirro, Cheikh Kane, Marsha Luna, Allan Xu, Stephanie Cape, Mark Odell, Robert Wheller, Hanna Ritzén, Esme Farley, Lisa Kierstead, William Mylott, Edward Tabler, Moucun Yuan, Shane Karnik, Troy Voelker, Ira DuBey, Clark Williard, Kelly Dong, Jing Shi, Jim Yamashita,

SARS-CoV-2 detection and testing

Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.