Researchers led by YanShan Dai in Nonclinical Disposition and Bioanalysis at Bristol Myers Squibb, Princeton, NJ, explored Reverse Transcription-droplet digital PCR (RT-ddPCR) for monitoring T-cell-mediated immunity by measuring IFN-g mRNA expression. Their study compares the effectiveness of RT-ddPCR to the widely used ELISpot assay for detecting antigen-specific T-cell responses, particularly in the context of SARS-CoV-2 vaccination. The authors demonstrate that RT-ddPCR offers comparable sensitivity to ELISpot, requires smaller blood volumes, and strongly correlates with ELISpot results. They conclude that RT-ddPCR is a reliable and efficient alternative for assessing cellular immune responses, especially when limited blood samples are available. The method could be valuable in vaccine trials, gene therapies, and oncology studies for evaluating drug product immunogenicity. The study also addresses the limitations of the technique and future applications.
Dai Y, Adusumilli A, Adeel F, Kozhich A, Jawa V. Monitoring antigen-specific cellular immune response using an RT-ddPCR-based assay for IFN-γ gene expression. J Pharm Sci. 2025 Feb;114(2):1017-1023. doi: 10.1016/j.xphs.2024.11.009. Epub 2024 Nov 26. PMID: 39603415. https://jpharmsci.org/article/S0022-3549(24)00514-8/fulltext
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