流式细胞分析仪检测细胞因子方法学性能验证  

Performance verification of BD FACSCanto^(TM) Ⅱ flow cytometry analyzer

作　　者：吴晗[1] 刘晨玢 毛胤祺 陈炜 陈淑英 WU Han;LIU Chenbin;MAO Yinqi;CHEN Wei;CHEN Shuying(Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Department of Laboratory Medicine,Huashan Hospital Affiliated to Fudan University,Shanghai 200040,China)

机构地区：[1]上海交通大学医学院,上海200025 [2]复旦大学附属华山医院检验医学科,上海200040

出　　处：《检验医学与临床》2021年第10期1345-1349,共5页Laboratory Medicine and Clinic

基　　金：国家自然科学基金面上项目(81772673);上海市青年科技英才杨帆计划(19YF1405400);复旦大学附属华山医院科研启动基金项目(2019QD003)。

摘　　要：目的对多重微球流式免疫荧光发光法测定细胞因子分析性能进行验证。方法参照中华人民共和国卫生行业标准文件和相关参考资料所提供的方案,在BD FACSCantoⅡ流式细胞分析仪上对细胞因子,包括白细胞介素(IL)-2、IL-4、IL-6、IL-10、IL-12p70、IL-17、干扰素γ和肿瘤坏死因子-α的精密度、准确度、线性范围、最低检测限、参考区间和抗干扰能力进行验证,用所测得的结果与厂家提供的性能指标进行比较。结果 8项细胞因子批内变异系数(CV)≤15%、批间CV≤15%、准确度相对偏差≤±15%、线性范围2.44~10 000.00pg/mL、最低检测限≤2.44pg/mL、试剂盒提供的参考区间适合该实验室及干扰偏差≤10%。结论流式细胞分析仪检测血浆细胞因子的方法学性能良好,测定结果准确可靠且重复性好,可满足临床需求,可用于实验室相关检测。Objective To verify the performance of multi-microglobular flow immunofluorescence spectrometry for the determination of cytokines.Methods According to the health industry standard document of the People′s Republic of China and the scheme provided by relevant reference materials,the precision,accuracy,linear range,minimum detection limit,reference interval and anti-interference ability of cytokines,including interleukin(IL)-2,IL-4,IL-6,IL-10,IL-12p70,IL-17,interferon-γand tumor necrosis factor-α,were verified by BD FACScantoⅡflow cytometry.The measured results were compared with the performance indexes provided by the manufacturer.Results The within-run coefficient of variation(CV)of 8 cytokines was≤±15%,the between-run CV was≤15%,the relative deviation of accuracy was≤15%,the linear range was 2.44—10000.00 pg/mL,the minimum detection limit was≤2.44 pg/mL,the reference interval provided by the kit was suitable for this laboratory and the perturbation deviation was≤10%.Conclusion The results show that the method of flow cytometry is accurate,reliable and reproducible,which can meet the clinical needs,and can be used for laboratory detection.

关 键 词：细胞因子 流式细胞术 性能验证 

分 类 号：R446.1[医药卫生—诊断学]