检验医学 ›› 2022, Vol. 37 ›› Issue (3): 270-273.DOI: 10.3969/j.issn.1673-8640.2022.03.016

• 技术评价·论著 • 上一篇    下一篇

2种6色流式细胞术试剂检测淋巴细胞亚群的性能比较

鞠颖慧, 莫惠芳, 吴蕙, 陈朴, 郭玮, 王蓓丽()   

  1. 复旦大学附属中山医院检验科,上海 200032
  • 收稿日期:2020-12-10 修回日期:2021-09-24 出版日期:2022-03-30 发布日期:2022-05-10
  • 通讯作者: 王蓓丽
  • 作者简介:王蓓丽,E-mail: wang.beili1@zs-hospital.sh.cn
    鞠颖慧,女,1990年生,学士,主管技师,主要从事临床检验工作;
    莫惠芳,女,1969年生,学士,主管技师,主要从事临床生化检验工作。第一联系人:鞠颖慧和莫惠芳对本研究具有同等贡献,并列为第一作者。
  • 基金资助:
    国家自然科学基金面上项目(81772263);国家自然科学基金面上项目(81972000);国家自然科学基金青年基金(81902139);2019厦门市医疗卫生重点项目(YDZX20193502000002);2017年上海市“上海青年临床医技人才(临床检验专业)培养资助计划;上海市临床重点专科建设项目(shslczdzko3302);复旦大学附属中山医院院内临床研究项目(2018ZSLC05)

Performance comparison of lymphocyte subset determination by 6-color flow cytometry with 2 different reagents

JU Yinghui, MO Huifang, WU Hui, CHEN Pu, GUO Wei, WANG Beili()   

  1. Department of Clinical Laboratory,Zhongshan Hospital,Fudan University,Shanghai 200032,China
  • Received:2020-12-10 Revised:2021-09-24 Online:2022-03-30 Published:2022-05-10
  • Contact: WANG Beili

摘要:

目的 比较国产6色流式细胞术试剂(简称国产流式试剂)与进口6色流式细胞术试剂(简称进口流式试剂)检测淋巴细胞亚群的性能。方法 选取不同地区的3家实验室检测淋巴细胞亚群的患者200例,分别使用国产流式试剂和进口流式试剂检测淋巴细胞亚群(CD3+细胞、CD4+细胞、CD8+细胞、CD19+细胞、CD3-CD16+CD56+细胞)的百分比和绝对数,同时计算染色指数(SI)和偏差。结果 国产流式试剂与进口流式试剂比较,CD3+细胞、CD8+细胞、CD19+细胞百分比及CD3+细胞、CD19+细胞绝对数检测结果差异均有统计学意义(P<0.05)。2种流式试剂检测CD3+细胞、CD4+细胞、CD8+细胞、CD19+细胞和CD3-CD16+CD56+细胞百分比和绝对数的平均偏移均<5%,一致性较好[组内相关系数(ICC)均>0.95,P<0.001]。Spearman相关分析结果显示,国产流式试剂与进口流式试剂的淋巴细胞亚群检测结果的相关性良好(r>0.9,P=0.000)。结论 国产流式试剂与进口流式试剂检测淋巴细胞亚群的结果虽有一定的差异,但相关性和一致性均较好。各临床实验室可根据自己的需求来选择合适的抗体试剂。

关键词: 淋巴细胞亚群, 流式细胞术, 相关性, 一致性

Abstract:

Objective To compare the performance of peripheral blood lymphocyte subset determination by flow cytometry with domestic 6-color flow cytometry reagents(referred to as domestic reagents) and imported 6-color flow cytometry reagents(referred to as imported reagents). Methods The whole blood samples from 200 patients from 3 clinical laboratories in different areas were determined by domestic reagents and imported reagents on the same flow cytometer to analyze the percentages and the absolute values of lymphocyte subsets(CD3+,CD4+,CD8+,CD19+,CD3-CD16+CD56+ cell). The staining indexes(SI) of lymphocyte subsets were calculated,and the deviation of the 2 reagents was evaluated. Results Compared with imported reagents,the percentages of CD3+ cells,CD8+ cells,CD19+ cells and the absolute values of CD3+ cells,CD19+ cells in domestic reagents had statistical significance(P<0.05). The average deviations of the percentages and the absolute values of CD3+ cells,CD4+ cells,CD8+ cells,CD19+ cells and CD3-CD16+CD56+ cells determined by the 2 reagents were <5%. The intraclass correlation coefficient(ICC) of the consistency was >0.95 for all the items(P<0.001). The results of Spearman correlation analysis showed that the determination results of lymphocyte subsets of domestic reagents and imported reagents had a good correlation(r>0.9,P=0.000). Conclusions Although the results of lymphocyte subsets with domestic reagents and imported reagents are somewhat different,the correlation and consistency are good. Each clinical laboratory can choose the appropriate antibody reagent according to its own needs.

Key words: Lymphocyte subset, Flow cytometry, Correlation, Consistency

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