2006年全国淋巴细胞免疫表型分析室间质量评价的分析

目的分析总结室间质量评价（简称质评）结果，发现和改进实验室检测过程中存在的问题，以提高实验室的检测质量和优化质控程序。方法选择、分装质评物，用单因素方差分析评价质评物中CD3^-、CD3^＋CD4^＋、CD3^＋CD8^＋和CD3^-CDl6^＋CD56^＋淋巴细胞的均匀性；设计质评回报表，将其与质评物一同寄到参加质评单位；分组统计回报表中的信息，计算及格率。结果质评物中各项目检测结果瓶问差异无统计学意义（P〉0．05）；回报表信息统计显示，应用室内质控物的参加单位仅为18％，检测中使用CD45-SSC设定淋巴细胞群方案的实验室占29％，进行绝对计数的实验室占14％。检测结果统计显示，各组间CD3^＋细胞百分比变化在1．06％-4．65％，CD^3-CDl6^＋CD56^＋细胞百分比差异较大，为0．99％-12．66％；4个项目的分组质评结果间差异无统计学意义（P〉0．05），及格率在86．0％一100．0％之间。结论本次质评活动所用质评物是均匀的，符合中国合格评定国家认可委员会要求，参评实验室组间检测结果的一致性涉及室内质量管理的完善程度、操作的规范性、质控物存放时间、标记和检测过程中的技术熟练程度等因素。做好室间质评是保证和了解实验室检测能力和水平的有效方法，需要质评检测和被检双方不懈努力才能做好。

National external quality assessment scheme for lymphocyte immunophenotyping in year 2006

Objective To analyze the results from external quality assessment（EQA） scheme, identify and remedy deficiencies in performance so as to improve the quality of laboratory practices. Methods The EQA control material was selected. The homogeneity of CD3^＋ cells, CD3^＋ CD^＋ cells, CD3^＋ CD8^＋ cells and CD3^- CD16^＋ CD56^＋ cells were evaluated by one way ANOVA; One send-around was designed to assess the performance of different laboratories and sent out with the specimens ; Submitted data were entered into a computer database to group and calculate the coeffecients of variation and pass rate. Results There were no significant difference among the aliquots of control material （P〉0.05）. According to the survey data, only 18% of participants used internal control material ; 29% of them choosed the gating method of CD45-SSC and 14% of them performed the absolute counting. CD3^＋ ceils had the lowest interlaboratory variability of 1.06% -4.65%, while CD3^- CD16^＋ CD56^＋ cells had the highest variability of 0.99%-12.66%. No significant difference was found between groups of four parameters（P〉0.05）. The pass rates of four parameters ranged from 86.0% to 100.0%. Conclusions The aliquots of control material in EQA are of homogeneity,which meet with the control requirement of China National Accreditation Service for Conformity Assessment（CNAS）. The interlaboratory variability may be attributable to the deficiencies of internal quality control, unstandardization of data acquisition method, the expired time of control and the technician＇s competence. EQA is a piece of effective measurement to investigate and guarantee the test competence. It would be made perfect only when the organizers cooperate with participants effortfully.