Technology Digest: defining specificity within the ELISpot assay
The enzyme-linked immune absorbent spot (ELISpot) assay provides important information on the abundance of low frequency immune cells, with an emphasis on the detection of antigen-specific T-cells or B-cells present within a patient. The assay can provide critical information regarding vaccination efficacy, autoimmunity and/or rejection and cytotoxicity.
As we enter an era in which even more therapies emerge for which there are limited specificity controls, it will be important to understand how each specificity assessment can guide our understanding of the assay results. In this Technology Digest, we review assay, donor and antigen specificity within the ELISpot assay.
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This eBook includes:
- TECHNOLOGY DIGEST: Defining specificity within the ELISpot assay
- WHITE PAPER: Recommendations on ELISpot assay validation by the GCC
- CASE STUDY: Immunogenicity assay development, validation & transfer in a vaccine candidate clinical trial
- WHITE PAPER: 2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
- WHITE PAPER: 2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
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