罗氏生化试剂用于奥林巴斯全自动生化分析仪的溯源性分析

目的：研究现用罗氏生化试剂系统在奥林巴斯全自动生化分析仪上使用的溯源性，即罗氏生化试剂系统与奥林巴斯试剂系统检测结果的一致性。方法：依据美国临床实验室标准化委员会(National Committee for Clinical Laboratory Standards，NCCLS)EP9-A文件，每天取患者样本8份，分别用两种试剂测定血清中常规14项生化指标，连续测定5天，记录检验结果，计算线性方程和相关系数，并以美国CLIA’88对室间评估的允许误差为判断依据进行结果的判断。结果：两种试剂系统所测得的检测结果相关性良好；除了ALB的中、低浓度范围、UA、CK、BUN、ALT的低浓度范围以及CREA、ALP外，其余项目的一定浓度范围均可在奥林巴斯全自动生化分析仪上使用罗氏试剂。结论：罗氏生化试剂系统在奥林巴斯仪器上使用，基本能得到具有临床意义一致的检测结果。

The Traceability Analysis about the Roech Biochemical Reagent System and the Olympus Biochemical Autoanalyzers

Objective:To study the reliability of the Roech Biochemical reagent system used of Olympus biochemical autoanalyzers.The consistency of the results of the two systems is also studied.Method:Based on the NCCLS EP9-A document,8 patients samples collected and analyzed 15 biochemical targets with two reagents respectively.The results were noted for 15 days.Linearity equation and the relativity coefficient were accumulated.According to the error allowable of CLIA'88 about the interlaboratory quality assessment,the results were judged.Result:The relativity of the results which was gotten with two regents systems is good.Some concentration range of some items may be used by Roech biochemical reagent system in the Olympus biochemical autoanalyzers.Conclusion:If the Roech Biochemical reagent system was used in the Olympus biochemical autoanalyzers,we could get the coherent results in the c1inical sense.