T淋巴细胞亚群分析全血质控物的评价及应用调查  

Evaluation and Application Investigation of the Whole Blood Quality Control Material for T Lymphocyte Subset Analysis

作　　者：王力[1] 彭明婷[1] 李臣宾[2] 朱晓雪[1] 

机构地区：[1]北京协和医学院,中国医学科学院,卫生部北京医院,卫生部临床检验中心,100730 [2]卫生部北京医院,卫生部临床检验中心

出　　处：《临床输血与检验》2009年第2期98-103,共6页Journal of Clinical Transfusion and Laboratory Medicine

基　　金：国家高技术研究发展计划(863计划)(No.2006AA020909)资助

摘　　要：目的对自制T淋巴细胞亚群分析全血质控物的均匀性和稳定性进行评价;发放质控物进行室间质量评价。方法依据ISOGuide35《标准物质/标准样品的定值—通用原则和统计原理》的要求,对自制质控物CD3+、CD3+CD4+、CD3+CD8+淋巴细胞百分比3个指标的均匀性、稳定性进行评价,同时以进口质控物作为对照。在组织淋巴细胞免疫表型分析项目室间质量评价活动中,向178家实验室同时发放进口质控物和自制质控物,并对调查结果进行分析和比较。结果自制20081027、20081111批号质控物及进口质控物的3个指标均匀性的不确定度范围分别为0.189%～0.318%、0.184%～0.280%、0.209%～0.284%。稳定性评价结果显示,自制质控物的3个指标随着保存时间变化的线性趋势无统计学意义(P>0.05),自制20081027、20081111批号质控物及进口质控物的3个指标长期稳定性的不确定度范围分别为0.554%～1.515%、0.189%～1.006%、0.328%～1.786%。室间质量评价调查结果显示,BD公司仪器组自制质控物与进口质控物的各指标变异系数(CV)范围分别为:2.94%～8.17%、2.84%～6.89%;Beckman Coulter公司仪器组自制质控物与进口质控物的各指标CV范围分别为:3.07%～14.25%、1.84%～5.14%。结论自制质控物的均匀性、稳定性符合要求,可用于流式细胞仪T淋巴细胞亚群分析的质量控制。Objective To evaluate the homogeneity and stability of the whole blood quality control material for T lymphocyte subset analysis which was prepared by National Center for Clinical Laboratories,and to investigate the spplication of the prepared quality control material in external quality assessment. Methods According to ISO Guide 35：Reference material-General and statistical principles for certification, the homogeneity and stability of the prepared quality control material in counting CD3^＋ cells,CD3^＋CD4^＋ cells, and CD3^＋CD8^＋ cells were evaluated;and the related imported quality control material were simultaneously evaluated for comparison. The prepared quality control material and imported quality control materials were tested in 178 laboratories which participated in the national external quality assessment scheme for lymphocyte immunophenotyping. Results The uncertainty of homogeneity for 20081027 and 20081111 lots of prepared quality control materials and imported quality control material were 0. 189%-0. 318% ,0. 184%-0. 280%, 0. 209%-0. 284% respectively. Stability test indicated there was no linear trend between the assayed values and time for the prepared control materials （P〉0.05）. The uncertainty of long-term stability for 20081027 and 20081111 lots of prepared quality control materials and imported quality control material were 0. 554-1. 515%, 0. 189%-1. 006%, 0. 328% -1. 786% respectively. The results of external quality assessment showed that the variability for prepared quality control materials and imported quality control materials in instruments of BD company group were 2.94 % - 8. 17 % , 2.84%- 6. 89% respectively; in instruments of Beckman Coulter company group they were 3.07%-14.25%,1.84%-5.14% respectively. Conclusion The prepared quality control materials meet the requirement of the homogeneity and stability for quality control material, and can be used for quality control in T lymphocyte subset analysis by flow cytometry.

关 键 词：淋巴细胞 免疫表型分析 质控物 均匀性 稳定性 室间质量评价 

分 类 号：R331.144[医药卫生—人体生理学] R392.12[医药卫生—基础医学]