腺苷脱氨酶自建检测系统及评价

目的比较北京利德曼生化股份有限公司生产的腺苷脱氨酶（ADA）检测试剂盒在Roche ModolarDPP全自动生化分析仪上建立的检测系统与Roche Modolar DPP可溯源的参考系统血清ADA检测结果之间的可比性和临床上可接受性。方法依据临床和实验室标准化协会（CLSI）标准中EP9-A文件对自建检测系统与可溯源参考系统检测门诊患者的40份新鲜血清ADA含量进行线性回归分析。结果自建系统和参考系统血清ADA检测结果具有很好的可比性。回归方程为Y=0.998 7 X＋0.090 2,其相关系数r2=0.998 4。结论自建系统血清ADA检测结果与Roche Modolar DPP可溯源的标准参考检测系统具有很好的可比性,可以代替参考系统检测临床标本,能够被临床所接受。

Comparison and evaluation of the self-established assay system for adenosine deaminase

Objective To evaluate the comparability and clinical acceptability of the results of serum adenosine deaminase（ADA） measured by self-established assay system with Beijing Leadman ADA kits in Roche Modular DPP clinical chemistry analyzers compared with traceable Roche Modular P reference assay system.Methods The concentrations of ADA in 40 fresh outpatient serum samples were analyzed in duplicate with two self-established systems and traceable Roche Modular reference system.The linear regression analysis was calculated according to National Committee for Clinical Laboratory Standards CLSI document EP9-A files.Results The comparability of serum ADA measurement results by self-established systems compared with Roche Modular reference system was acceptable.The regression equation was Y=0.998 7X＋0.090 2,and the correlation coefficient（r2） was 0.998 4.Conclusion The results of serum ADA measured by our self-established systems have good comparability compared with Roche Modular P reference system,and it can replace the reference system to detect clinical specimens,which could be acceptable by clinical application.