16 Mart 2023
“Efficient Quality Assurance for the Flow Cytometry Laboratory”
Presented by Dr. Francesco Buccisano
Nowadays, a well-designed quality assurance system is a mandatory requisite of any modern flow-cytometry facility. Furthermore, the wide diffusion of highly performing instruments, the increased number of reagents and the urge of “reproducibility” raised by several stakeholders (clinicians, regulatory entities, patients) has exacerbated the need of official guidance in this field. Both regulators and scientific societies have produced a large number of documents that, at different levels, have detailed not only the technical preparation of samples but also the analytical phase, the reporting and the skill matrix of the personnel involved in each step of the process. The ultimate goal is “standardization” (e.g. the complete uniformization of each methodical steps) or “harmonization” (e.g. agreement on the key steps of the method) of the analytical process. The choice depends on the specificity of the disease and the purpose of the test. This approach may have huge impact in several fields, from monitoring of immunotherapies, measurable residual disease assessment and drug development. The aim of this presentation is to briefly examine what are the principal tools that need to be regulated and how the quality of different types of analysis may be improved by the quality assurance systems.