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The Applied/Developmental Research Directorate maintains a Clinical Services Program that has expertise covering a broad spectrum of immunologic testing and clinical trial support. Program support can begin at the early stages of clinical trial development to aid in developing a comprehensive strategy for sample collection, processing, and testing with a special emphasis on immunologic testing. Program laboratories collaborate with partners to develop customized assays or transfer existing assay technology with assay validation, data analysis and interpretation of results. The sample (whole blood or apheresis product) is delivered to the facility and processed under standardized protocols for optimal isolation of peripheral blood mononuclear cells, serum, and/or plasma samples, which are then cryopreserved. Downstream activities can include:
- Using multiplex assays to evaluate cytokine & chemokine levels in humans
- Routine and customized assays of lymphocyte functional activity including proliferation, ELISPOT, and NK cell- or CTL-mediated cytotoxicity assays
- Establishing customized flow cytometry panels for clinical trial monitoring
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