Validation and Standardization of flow cytometry based immune monitoring in clinical trials
Institut für Medizinische Immunologie, Charité – Universitätsmedizin Berlin
Flow cytometry is an important tool within immunological research and immune diagnostic. The current technical developments improve the handling and precision of flow cytometers but also increase the complexity of cytometry systems with respect to the numbers of variables that need to be controlled. In addition the lack of reference material and the insufficient comparison with other methods hinders the determination of the accuracy of flow cytometry data. Therefore the data quality is directly linked to the description of the imprecision and the stability of a flow cytometry based immune monitoring. At the moment, increasing interest in the effects of therapeutics on the immune system results in an increase of flow cytometry based immune monitoring in clinical studies. Therefore, quality of data becomes more important and harmonization, standardization and validation come more to the focus of immune monitoring. On the other hand this competes with the material costs and the consumption of lab resources. In addition, even if a number of guidelines report the different technical aspects of flow cytometry and provide protocols for the phenotyping of major players of the immune system, there are only few agreements about minimal standards for the determination of the imprecision and stability of a flow cytometry based diagnostic tests or immune monitoring via flow cytometry. Here we describe the necessary procedures for the validation and standardization based on the experiences within clinical diagnostic and the validation of multi-center clinical trials.