淋巴细胞亚群流式细胞术检测质量管理临床实践专家共识  

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

作　　者：中国中西医结合学会检验医学专业委员会 杨再林 武坤[3] 杨曦明[4] 刘耀 王卉 吴丽娟 陈双 程沈菊 龚容[3] 蒋亭亭 李轶勋[3] 林灿 彭余 唐鑫怡 赵明宇 Laboratory Medicine Committee of Chinese Association of Integrative Medicine;Yang Zailin;Wu Kun;Yang Ximing(不详;Department of Hematology-Oncology,Chongqing University Cancer Hospital,Chongqing 400030,China;Department of Clinical Laboratory,First Affiliated Hospital of Kunming Medical University,Kunming 650032,China;Department of Pathology,Dongzhimen Hospital Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]不详 [2]重庆大学附属肿瘤医院血液肿瘤中心,重庆400030 [3]昆明医科大学第一附属医院医学检验科,昆明650032 [4]北京中医药大学东直门医院检验病理科,北京100700 [5]河北燕达陆道培医院检验科 [6]西部战区总医院实验室医学中心

出　　处：《中华预防医学杂志》2024年第11期1641-1650,共10页Chinese Journal of Preventive Medicine

摘　　要：流式细胞术检测外周血淋巴细胞亚群,用于评价机体细胞免疫水平,是临床广泛开展的流式细胞术检测项目之一。迄今为止,国内外诸多机构及学术组织发表了多篇相关的指南与共识,涵盖了流式细胞实验室建设、淋巴细胞亚群检测的标准化操作流程、在不同领域的临床应用等方面内容,其各有侧重点。然而在临床实践过程中,实验室依然面临着如何建立规范的质量管理体系、如何开展质量管理活动、不同情况下如何制订符合要求的检测方案及设门策略、检测过程中的常见问题原因分析及如何处理等方面的问题,目前缺乏统一的认识。为了规范淋巴细胞亚群流式细胞术检测质量管理体系的建立与质量管理活动的开展,进一步提升实验室对该项目的质量管理水平,保证其检测结果的准确性和可靠性,由中国中西医结合学会检验医学专业委员会组织专家制订了本专家共识。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.

关 键 词：淋巴细胞亚群 流式细胞术 质量管理 

分 类 号：R446[医药卫生—诊断学]