Qualification of a whole blood intracellular cytokine staining assay to measure mycobacteria-specific CD4 and CD8 T cell immunity by flow cytometry

BM Kagina, N Mansoor, EP Kpamegan… - Journal of …, 2015 - Elsevier
Background Qualified or validated assays are essential in clinical trials. Short-term
stimulation of whole blood and intracellular cytokine staining assay is commonly used to
measure immunogenicity in tuberculosis vaccine clinical trials. Previously, the short-term
stimulation process of whole blood with BCG was optimized. We aimed to qualify the
intracellular cytokine staining process and assess the effects of long-term cryopreservation.
Our hypotheses were that the assay is robust in the measurement of the mycobacteria …