流式细胞术作为一项多参数、高通量的细胞分析和分选技术，已在临床诊疗中获得广泛应用。我国众多医疗机构及第三方医学检验实验室相继建立了相关检测平台。然而，实验室建设的标准化进程明显滞后于技术发展速度，目前尚缺乏国家层面的系统性指导文件，导致实验室在布局规划、仪器与试剂选择、检测项目设置及人员培训等方面存在不规范现象，制约了该技术优势的充分发挥。为系统规范临床流式细胞实验室的建设与管理，中华医学会检验医学分会分子诊断学组、中华医学会检验医学分会临床免疫学组、中国民族卫生协会流式细胞技术临床应用推广组联合国内相关领域专家，在整合ISO 15189《医学实验室 质量和能力认可准则》、美国临床和实验室标准协会（CLSI）相关指南、国际流式细胞协会（ISAC）实践经验的基础上，结合我国实际国情，制定了本共识。共识内容涵盖通用要求、人员要求、实验室设计与建设要求、分析仪器与辅助设备配置、试剂与耗材管理等多个关键环节，旨在为各级医疗机构和第三方检测机构提供全面、可操作的指导。通过推行本共识，期望能够提升我国流式细胞检测结果的准确性、可比性与可靠性，更好地服务于临床诊疗的需求。

Flow cytometry, a multi-parameter, high-throughput cell analysis and sorting technology, is now widely used in clinical practice. While many medical institutions and third-party laboratories in China have established testing platforms, the standardization of laboratory construction lags significantly behind the technology's rapid development. The absence of systematic, national-level guidance has resulted inconsistencies and non-standard practices in laboratory layout, equipment and reagent selection, assay configuration, and personnel training, limiting the full potential of this technology. To address the need for systematic standardization in clinical flow cytometry laboratories, the Molecular Diagnostics Group and the Clinical Immunology Group of the Chinese Society of Laboratory Medicine, in collaboration with the Flow Cytometry Clinical Application Promotion Group of the China National Health Association and domestic experts, have developed this consensus based on the integration of ISO 15189, relevant CLSI guidelines, and the practical experience of ISAC, adapted to the specific context of China. This consensus addresses key areas such as general requirements, personnel requirements, laboratory design and construction, configuration of analytical and auxiliary instruments, and management of reagents and consumables. Its aim is to provide comprehensive and practical guidance for medical institutions at all levels and third-party testing laboratories. The widespread adoption of this consensus is expected to enhance the accuracy, comparability, and reliability of flow cytometry testing in China, thereby better serving clinical needs.