Objective To study whether the non-matching detection system can be calibrated by different manufacturer's calibrators. Methods According to National Committee for Clinical Laboratory Standards document EP9-A2.with Roche Modular System as standard detection system (S1), used Level 3 and Level2 from RANDOX,C-fas calibrator to calibrate the same detection system which consisted with same reagents,procedures and analyzer as comparative systems (system2- 4),and then tested 40 serum in the four systems with ten items. Each specimen measured twice,then took the mean value. The bias between experimental testing systems and aim system could be evaluated. The comparability of different investigated system was judged according to the half of clinical laboratory improvement amendment 88(CLIA'88) allowed total error. Results The results of Tbil ,Dbil, ALP and CK showed comparability between system 2 and system 1 ,the results of Tbil and GGT showed comparability between system 3 and system l?the results of Glu showed comparability between system 4 and system 1 .and the other items were not comparable. Conclusion Calibrators from different manufacturers could not be directly used for calibration of the non-matching detection system. One clinical testing system should had its own calibrator.%目的 观察不同厂家的校准品能否直接校准非配套的检测系统.方法 参考美国临床实验室标准化委员会的EP9-A2文件,以罗氏检测系统为目标检测系统(系统1),用罗氏C-fas、朗道校准品Level2和Level3分别与国内某一厂家生产的生化分析仪器、试剂和检测程序组成待评检测系统(系统2～4),然后用上述四个检测系统分别检测40份新鲜患者血清中的总胆红素(TBil)等10个项目,每个标本测定两次,结果取均值.计算待评检测系统(Y)与目标检测系统(X)之间的相对偏倚,以美国临床医学检验部门修正法规(CLIA'88)允许总误差的1/2为标准,判断检验结果的可比性.结果 系统2与系统1的TBil,DBil,ALP和CK具有可比性,其他项目不具有可比性.系统3与系统1的TBil和GGT具有可比性,其他项目不具可比性.系统4与系统1的Glu具有可比性,其他项目不具可比性.结论 不同厂家生产的校准品不能直接用于校准非配套检测系统,每一检测系统都必须具有自己的配套校准品.
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