应用EP9-A文件对三台生化分析仪的比对分析

Compare of three different automatic biochemistry analytical systems based on the EP9-A document

目的探讨不同生化分析仪检测结果的可比性和临床可接受性。方法以罗氏试剂、罗氏cfas校准液、罗氏7600全自动生化分析仪为标准检测系统,标佳试剂及自带校准液、雅培AEROSET全自动生化分析仪为待检测系统(以下简称雅培A),德赛试剂及自带校准液、另一台雅培AEROSET全自动生化分析仪为另一待检测系统(以下简称雅培M)。用罗氏7600、雅培A和雅培M检测系统同时测定40份新鲜人血清的总蛋白(TP)、肌酐(Crea)、钙(Ca)和镁(Mg)四项生化指标,并将所得结果根据NCCLS提供的标准化文件EP9-A中的对比方法进行线性回归分析。结果同一新鲜混合血清在三台仪器上检测CV均<2.5%,精密度良好,结果稳定。四个项目的相关系数R2均>0.95,说明各检测系统有良好的线性和相关性。雅培A系统Crea、Ca和Mg在医学决定水平L值处的相对系统误差(SE%)>1/2CLIA'88允许误差(Ea%),其余值均<1/2CLIA′88 Ea%;雅培M系统Crea和Ca的H值及Mg的M、H值的SE%<1/2CLIA′88 Ea%,其余值均>1/2CLIA'88 Ea%。结论雅培A系统偏倚可接受,基本能得到具有一致临床意义的检测结果;雅培M系统大部分系统误差不可接受,应根据回归方程系数进行相应调整。实验室对比试验能对检测能力进行有效的质量监控,实验室其他项目对比工作需要不断完善。

Objective To compare different automatic biochemistry analytical systems. Methods Regard Roche 7600 automatic biochemical analyzer using Roche reagents and Roche Cfas calibration solution as the standard analyzer system, Abbott AEROSET automatic biochemical analyzer system using Biaojia reagents coming with calibration solutions as detected system （Abbott A） and another Abbott AEROSET automatic biochemical analyzer using Desai reagents coming with calibration solutions as another detected system （Abbott M） were compared. Using the Roche 7600, the Abbott A and the Abbott M were used to detect the total protein （TP）, creatinine （Crea）, Calcium （Ca） and Magnesium （Mg） of 40 fresh human serum samples, and analyzed the linear regression of the results according the EP9-A of NCCLS. Results The same fresh mixed serum sample was analyzed by three different systems and the CVs of the results were all 〈2.5%, meaning that the precision was good and the resuhs were stable. The relative systematic error （SE%） evaluation： The results of Crea, Ca and Mg detected by A system in the L of medical decision level was 〉1/2 CLIA＇88 permissible error （Ea%）, and the other SE% were all 〈 1/2 CLIA＇88 Ea%. For the Abbott M system, the results of Crea and Ca in the H of medical decision level and the results of Mg in the M,H of the medical decision level＇s SE% were 〈I/2 CLIA＇88 Ea%, and for the other systems the SE% were all 〉 1/2 CLIA＇88 Ea%. Conclusions The bias of Abbott A was acceptable, basically having the same detection result of clinical significance. Most of the system errors of Abbott M were unacceptable. The coefficients should be adjusted according to the regression equation. Comparative study of the analytical systems can assure the detection quality. Other systems of diagnostic laboratories should also be compared to improve their quality of detection.