不同检测系统7种血清酶活性测定结果比对及分析

Comparison and analysis of 7 serum enzymes detected by different detecting systems

目的:探讨相同实验室不同检测系统间血清酶活性测定结果的差异及提高其可比性的途径。方法:以贝克曼LX20pro全自动生化分析仪及原装试剂、质控品组成的检测系统为比较方法(X),检测系统2～5为实验方法(Y),参考美国临床实验室标准化委员会(NCCLS)EP9-A2文件,测定病人新鲜血清中ALT、AST、ALP、GGT、LDH、CK、CKMB 7种酶活性,对Y和X两法的酶活性结果进行比较并计算其相对偏差(%SE),同时计算系统2、4、5校准后结果间的相对偏差,以美国临床实验室修正法规(CLIA′88)规定的室间质量评价允许误差范围的1/2为标准,分析不同系统测定结果的可比性。结果:除系统2、5的GGT项目,系统2的CK项目无显著性差异外,其它测定结果均有显著性差异(P<0.05;P<0.01);校准后,实验检测系统2、4、5的系统误差除GGT和LDH外,其它项目均有明显减小。结论:酶校准品的应用可减少某些项目的系统误差,但不能完全提高上述6种酶(ALT、AST、ALP、GGT、LDH、CK)测定结果的可比性。实验室应根据本室的实际情况,对不同的检测系统进行比对试验并作出偏差评估后,选择合适的解决方法来提高酶活性测定结果的可比性。

Objective：To study the differences of results of serum enzyme detected by different biochemical detecting systems in the same laboratory and the ways to improve their comparability.Methods：Detecting systems 2~6 were chosen as laboratory methods（X） and BECKMEN COULTER LX20pro biochemical analyzing system including its reagent of original installation,and control of original installation was chose as comparison method（Y）.According to NCCLS document EP9-A2,7 serum enzyme items including ALT,AST,ALP,GGT,LDH,CK and CKMB were tested by laboratory methods and comparison method.The results obtained by the X and Y were compared and the system bias were counted.The bias of system 2,4,5 which had been calibrated were counted.According to clinical laboratory correcting code（CLIA′88）,the comparability of different detecting systems were analyzed according to the standard of half of the range of error allowed of quality evaluating within different Labs.Results：Except for system2,system 5（GGT） and system 2（CK）,there were remarkable differences between X and Y（P〈0.05;P〈0.01）.After calibrating except for GGT and LDH of system2,4,5,the differences decreased obviously compared to system1.Conclusion：Enzyme calibrators could decrease system errors of some testing items,but they could not completely improve the comparability of the results of the 6 enzymes（ALT,AST,ALP,GGT,LDH,CK） above.According to actual situation of laboratory,it is necessary for every laboratory to do method comparison and bias estimation and choose suitable method to improve the comparability of the results of serum enzyme detection.