Consensus of experts on clinical quality management for flow cytometry-based detection of lymphocyte subsets

Abstract

Flow cytometry (FCM) is used to detect lymphocyte subsets and evaluate the level of cellular immunity in the body, which is one of the commonly used FCM detection projects in clinical practice. To date, numerous institutions and academic organizations, both domestically and internationally, have published guidelines and consensus documents covering various aspects, including the establishment of cytometry laboratories, standardized procedures for detecting lymphocyte subsets, and their clinical applications across different fields, each with a distinct focus. However, in clinical practice, laboratories continue to face challenges in establishing standardized quality management systems, implementing quality assurance activities, developing appropriate detection protocols and gating strategies for various scenarios, and identifying and resolving common issues encountered during detecting. Currently, there is no unified consensus on these issues. To standardize the development of quality management systems for lymphocyte subsets detecion via FCM, enhance laboratory quality management practices, and ensure the accuracy and reliability of results, the Laboratory Medicine Committee of Chinese Association of Integrative Medicine (LMC-CAIM) convened experts to formulate this expert consensus.