We evaluated the sample stability for a cellular kinetics and a pharmacodynamic flow cytometry methods. First, the blood collection tubes were compared for the enumeration of chimeric antigen receptor-T cells in human whole blood. Blood samples with chimeric antigen receptor-T cells were stable up to 3 days at room temperature in both conventional EDTA and Cyto-Chex® blood collection tubes (Streck Laboratories, NE, USA), but with better consistency in Cyto-Chex-BCT than conventional EDTA tubes. Second, sample storage temperatures were compared for the basophil activation test in human whole blood samples. The samples were stable up to 3 days for basophil activation test when stored at refrigerator temperature, but not stable when stored at room temperature. It is crucial during the development of method to evaluate all the variables which might impact sample integrity.
Keywords: CAR-T cell; basophil activation; cellular kinetics; flow cytometry; sample stability.