日立7170A、COBAS检测系统间血清酶测定结果的可比性研究

The comparative study on the results of serum enzymes between Hitachi 7170A and COBAS Integra 400 plus

目的:对同一生化实验室两台分析仪进行方法对比和偏差评估,探讨不同仪器间血清酶测定结果是否具有可比性。方法:以可溯源的日立7170A生化分析仪,罗氏原装试剂及程序,c.f.a.s校准品和质控品组成的检测系统作为目标检测系统(Y),罗氏COBAS Integra 400 Plus为待评系统(X),在20个工作日内分别测定罗氏正常、病理水平质控物各20次和新鲜血清样本40份。计算目标检测系统与待评系统之间的相对偏差(%SE),以美国临床实验室修正法规规定的室间质量评价允许误差范围的1/2为标准,判断不同检测系统之间的可比性。结果:经随机区组资料设计的方差分析,罗氏质控物和新鲜样本天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)、肌酸激酶(CK)、肌酸激酶同功酶(CK-MB)测定值二检测系统间的总体差异无显著性(P>0.05),系统间的相关系数均大于0.975。两系统所有项目测量结果的系统误差临床可接受。结论:二检测系统4种酶测定结果之间具有可比性,能满足临床的需求。

Objective ：To study the comparability on the results of serum enzymes between Hitachi 7170A and C OBAS Integra 400 plus.Methods：With the Hitachi7170A biochemical analyzers,Roche reagent and program,Roche c-fas calibration as a target system, COBAS Integra 400 plus as comment system.The AST.LDH.CK.CK-MB were analysed in 41.32.32.30 patient fresh sera respectively and 2 levels of Roche controls.It was judgement whether the results on different analysis systems were comparability according to the half of CLIA,88 with calculation the system bias between target system and comment system.Results：Analysis of variance showed the results of patient sera enzymes had no significant difference between two detection system, and also the correlation coefficient was all above 0.975. The system errors on the all results between Hitachi 7170A and COBAS Integra 400 plus were clinical acceptable. Conclusion：The resuits of AST,LDH,CK.CK-MB between two analysis systems were comparable,and able to satisfy clinical need.