流式细胞术淋巴细胞亚群检测室间质评结果分析

Analysis on the results of external quality assessment of lymphocyte subsets by flow cytometry

目的通过分析卫生部临床检验中心、上海市临床检验中心的淋巴细胞亚群室间质量评价（EQA）报告数据以及上海市2家实验室室内质控上报数据，探讨目前国内淋巴细胞亚群检测EQA评判规则的合理性，为进一步提高国内该检测项目的质量水平提供依据。方法对BD流式细胞仪用户组2014年卫牛部临床检验中心及2015年上海市临床检验中心第1次淋巴细胞亚群EQA报告数据进行统计，计算各浓度质评样本上报数据的标准差（S）和变异系数（CV），选取上海市2家BD流式细胞仪用户2014年9月至2015年4月期间的淋巴细胞亚群室内质控数据，计算月s和月CV值。并对卫生部临床检验中心第201403和201405号质评样本CD3^＋CD4^＋百分比（CD3^＋CD4^＋％）项目（靶值分别为42．7％、42．1％）、上海市临床检验中心第1521和1525号质评样本CD3^＋CD4^＋％项目（靶值分别为43．2％，44．13％）的回报数据以及2家上海市临床实验室CD3^＋CD4^＋％项日中值水平（月组均值为44．39％～46．80％）室内质控数据进行比较分析。结果2014卫生部临床检验中心5份EQA样本的s为1．10％～1．55％，CV为3．1％～5．5％，平均CV为3．36％；2015年上海市临床检验中心第1次EQA5份样本的s为0．67％～1．63％，CV为3．51％～8．64％，平均CV为4．83％。在样本CD3^＋CD4^＋％值相近的情况下，卫生部临床检验中心2个EQA样本组S（1．55％、1．35％）和组CV（3．6％、3．2％）、上海市临床检验中心2个EQA样本的组s（1．63％、1．55％）和组CV（3．78％、3．51％）均在上海市2家临床实验室室内质控月s（1．06％～2．44％、0．98％～2．03％）和月CV（2．18％～5．28％、2．14％～4．35％）的变化范围之内。结论由于仪器品牌和型号、溶血方法、荧光抗体的品牌和用量、设门方法、实验人员、环境条件等不同因素的影响，EQA数据统计中的s和CV低于室内质控的s和CV不合理。其原因可能是部分参与EQA的实验室在数据上报前对检测结果进行了交流、核对和更改。当前除了加强对实验室的质量教育外，EQA组织者还需要探讨建立更合适的质控规则。

Objective To evaluate the assessment rationality scheme of external quality assessment （EQA） for the analysis of lymphocyte subsets by comparing the data from the lymphocyte subset EQA in the National Center for Clinical Laboratory and Shanghai Center for Clinical Laboratory and the submitted data of internal quality control from 2 laboratories in Shanghai, in order to improve the analysis quality of lymphocyte subsets. Methods The data of BD flow cytometry group from the National Center for Clinical Laboratory EQA in 2014 and Shanghai Center for Clinical Laboratory EQA for the first time in 2015 were analyzed statistically, and the standard deviation （s） and coefficient of variation （CV） were calculated. The internal quality control data from 2 laboratories in Shanghai were collected from September 2014 to April 2015, and the s and CV were calculated. The CD3 ~ CD4 ~ percentage （ CD3 ~ CD4 ~ % ） data of Sample 201403 and Sample 201405 （ target values： 42. 7% and 42. 1% ） from the National Center for Clinical Laboratory, Sample 1521 and Sample 1525 （target values： 43.2% and 44. 13% ） from Shanghai Center for Clinical Laboratory and the submitted internal quality control data （ monthly mean 44.39% - 46.80% ） of 2 laboratories were analyzed comparatively. Results The s and CV of 5 EQA samples from the National Center for Clinical Laboratory in 2014 were 1.10% -1.55% and 3.1% -5.5% , respectively, and the average CV was 3.36%. The s and CV of 5 EQA samples for Shanghai Center for Clinical Laboratory in 2015 were 0. 67%-1. 63% and 3.51%-8.64% , respectively, and the average CVwas 4.83%. In the situation of data with approximate means, the group s （ 1.55% and 1.35% ） and group CV （3.6% and 3.2% ） from the National Center for Clinical Laboratory and the group s （ 1.63% and 1.55% ） and group CV （3.78% and 3.51% ） from Shanghai Center for Clinical Laboratory were less than those of internal quality control data from 2 laboratories （ monthly s 1.06% -2.44% and 0.98% -2.03% ; monthly CV 2.18% - 5.28% and 2.14% -4.35% ）. Conclusions It is irrational that the s and CV of EQA are less than those of internal quality control since different impacts from the factors such as instrument brands and models, lysis techniques, brands and volumes of antibodies, gating strategies, experimenters and environment conditions and so on. One of the possible reasons may be that some laboratories exchanged, checked and sometime modified the EQA data before submitting the data. Other than improving the quality education for the laboratories, the solution can be the establishment of rational marking scheme.