目的：探讨同一实验室不同检测系统的可比性。方法：按照美国临床实验室标准化协会(NCCLS)EP9-A2文件要求，以贝克曼-库尔特DXC-800系统为目标系统，日立7600检测系统为比较检测系统，每天随机选取8份体检者新鲜血液标本，测定ALT,AST,Cr,GLU4个常规生化指标，连续测5d，记录测定值，计算贝克曼-库尔特DXC-800系统（X）和日立7600系统（Y）的相关系数r和相对偏移（SE%），以国家卫计委推荐的TEa的1/2为标准，分析两个系统的相关性以及评价两个系统的临床可接受性。结果：两个系统相关性良好，r2>0.95，两个系统检测的4各项目在低、中、高三个医学决定水平的SE%均小于1/2国家卫计委推荐的总误差（TEa），比较无差异性，为临床可接受。结论：定期用新鲜血进行比对试验，对同一实验室的两个生化检测系统进行相关性和可接受性评价十分必要，满足了ISO/IEC17025和ISO15189对实验室提出的要求，既保证了检验质量也为实验室认可提供了依据。%Objective:To discuss the comparability of different detection systems in the same laboratory.Methods:According to NCCLS document EP9-A2,ALT,AST,Cr and GLU of 8 random fresh blood samples were detected by Beckman Coulter testing system(targeted testing system)and Hitachi7600 biochemical analyzer system(comparative testing system) continuously for 5 days.After we recorded the data,we calculated the correlation coefficients(r) and the relative deviation(SE%) of Beckman Coulter testing system(X) and Hitachi7600 biochemical analyzer sysyem(Y).According to the half of TEa recommend by national health development planning commission,we evaluate the correlation and the clinical acceptability of the two systems.Results:The correlation of the two systems is good.Correlation coefficients(r2) ≥0.95.The relative deviations(SE%) in the 3 medical decision level of the 4 projects are less than the half of TEa recommend.The two detection systems had no significant difference.The results detected by the two detection systems are acceptable.Conclusions:To do the comparison using fresh blood samples and to Using fresh blood samples to do the comparison test to evaluate the correlation and clinical acceptability of two different detection systems in the same laboratory is very necessary on a regular basis. The comparison test meet the requirement of ISO/IEC 17025 and ISO 15189 and ensure the quality of laboratory experiment. It also provides the basis for laboratory accreditation.
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