奥林巴斯AU1000和贝克曼CX7检测系统肝功能测定结果的对比研究

A Comparative Study on the Results of Liver Function between Olympus AU1000 and Backman CX7 Detection Systems

目的通过对奥林巴斯AU1000和贝克曼CX7检测系统进行方法对比分析,探讨两系统之间肝功能检测结果是否具有可比性。方法依据美国临床实验室标准化委员会(NCCLS)EP9-A文件要求,每天取新鲜血清样本8份,分别用奥林巴斯AU1000检测系统和贝克曼CX7检测系统测定肝功能10项常规指标,连续测定5天,并计算线性回归方程和方法间的系统误差,以美国临床实验室修正法规(CLIA,88)建议的医学决定水平处的系统误差来判定不同检测系统之间的可比性。结果两个检测系统新鲜血清样本测得的结果在均值处的配对t检验均无统计学差异(P>0．05);医学决定水平处的系统误差除白蛋白的低值超出允许误差外,其余各检测项目医学决定水平处的系统误差均在允许误差内。结论奥林巴斯AU1000和贝克曼CX7检测系统肝功能测定结果相关性良好,两系统之间的系统误差能为临床所接受。

Objective To study the comparability of liver function results between the two detection systems. Methods Based on the NCCLS EP9-A document, 8 fresh serum samples were collected daily for the assay of 10 routine liver function parameters by utilizing the Olympus AU1000 and Backman CX7 detection systems respectively. The results were recorded over 5 days consecutively. Linearity equation and relative deviations were calculated. The comparability between the results obtained from different detection systems was evaluated according to the systematic error at medical decision level of CLIA, 88. Results The paired t-test showed that the results of the fresh serum samples had no significant difference between the two detection systems （P〉0.05）. Except that the systematic error of albumin at low medical decision level exceeded the allowable error, all the other systematic errors at medical decision level were acceptable. Conclusion The results of liver function are comparable between the two detection systems, and the systematic errors between the two detection systems are clinically acceptable.