中文摘要：

目的调查临床实验室淋巴细胞亚群的检测现状,结合全国室间质量评价数据进行分析,为质量改进提供依据。方法以参加全国淋巴细胞亚群检测室间质量评价的200家为调查对象,通过问卷调查,收集相关检测信息,并将2011～2013年的全国室间质评数据与同期美国Wadsworth Center质评数据进行比较,分析检测现状。结果调查问卷回报率为87.5%;三级医院的实验室占88.6%;使用光路流路校准品、PMT电压校准品和荧光补偿样品的实验室各占97.7%、88.6%和88.6%;实验室均采用包括CD3抗体在内的至少2种抗体进行T细胞亚群和NK细胞检测;26.3%的实验室曾使用全血质控物开展室内质控;38.5%的实验室使用CD45/SSC设门;30.3%的实验室报告绝对计数值,其中采用单平台方法的占62.3%。2011～2013年全国淋巴细胞亚群检测质评CD3＋、CD3＋CD4＋、CD3＋CD8＋、CD3-（CD16＋56）＋和CD3-CD19＋五类细胞的相对计数的变异系数分布范围为（3.0～9.8）%,绝对计数的变异系数分布范围为（15.8～30.4）%,而美国质评相对计数和绝对计数的变异系数分布范围分别为（2.0～10.0）%和（7.0～13.0）%。结论参加淋巴细胞亚群检测质评的实验室主要来自各地的三级医院,其检测能力代表了我国淋巴细胞亚群检测的较高水平;流式细胞仪检测状态的质量监控已在开展,但样本检测过程的质量控制（如全血质控品应用、设门方案等）未有效开展;我国质评计划结果中相对计数的变异系数略高于美国,而绝对计数的变异系数差距更明显。应进一步制订相关标准并实施标准化。

英文摘要：

Objective To investigate the current status of lymphocyte subsets detections in clinical laboratories in China and to analyze the external quality assessment data in order to provide information of quality improvement.Methods The survey was conducted by means of questionnaires in 200 laboratories that participated in national external quality assessment for lymphocyte subsets assays.The class of medical facility,model of instrument,quality control of the instrument,reagents,quality control of sample processing,gating policy,reporting mode were collected and analyzed.The coefficient of variation was compared between China EQA and America Wadsworth Center EQA from 2011 to 2013in order to evaluate the laboratory assay proficiency.Results One hundred and seventy-five questionnaires were received and the reply rate was 87.1%.88.6% of questionnaires came from first-class hospitals.The usage rates of fluidic and optic calibrator,PMT calibrator and fluorescence compensation sample were 97.7%,88.6% and 88.6%.T subsets and NK cells were measured by at least 2kinds of antibodies including CD3 in all laboratories.Only 26.3% participants used the whole blood control material to perform quality control of sample processing.38.5% participants applied CD45/SSC gating.30.3% participants reported absolute counting,among them 62.3% participants used single platform absolute counting.The median of coefficient variation（CV）of percentage and absolute counting for CD3＋,CD3＋CD4＋,CD3＋CD8＋,CD3-（CD16＋56）＋,and CD3-CD19＋ cells were（3.0～9.8）% and（15.8～30.4）%,while the median of CV of percentage and absolute count of American Wadsworth Center were（2.0～10.0）% and（7.0～13.0）%.Conclusions The detection proficiency in the majority of participants from the first-class hospitals represents the better measurement level in China.The quality control of flow cytometer is widely used while the quality control of sample processing（such as application of control materials,gating policy,etc.）has not been pe