奥林巴斯AU 600与德灵XPand plus两台生化分析仪检测结果的可比性分析

The comparative study on the testing results between OYLMPUS AU600 and Dimension Xpand plus automatic biochemistry analyzer

目的探讨不同溯源的生化检测系统间相同检测项目测定结果的可比性,其误差是否能被临床所接受。方法按照美国临床和实验室标准化协会(CLSI)EP5-A及EP9-A文件的要求,我们对两套生化系统做了精密度评价,以OLYMPUS AU600生化分析仪检测系统为实现溯源性和可比性的目标检测系统(X),以新引进的德灵Xpand plus生化分析仪为待评检测系统(Y),在8个工作日内分别测定正常、异常质控物各8次及分别对80个新鲜血清标本进行测定BUN、CR、UA、AST、CK、LDH 6个生化项目,通过线性回归分析及计算目标检测系统与待评系统之间的相对偏差(SE%),以美国临床实验室改进修正法规′88(CLIA′88)规定的室间质量评价允许误差范围的1/2 CLIA′88为标准,在不同医学决定水平判断不同检测系统的偏差是否可被临床接受。结果在所有检测项目中,除BUN、UA测定结果在个别医学决定水平的偏差不能被临床接受外,其余项目两套系统测定结果的偏差均可被临床接受。结论我科两套生化检测系统共有测定项目的大部分测定结果具有可比性,可满足临床需要,新购置的德灵生化分析仪同样能为临床诊断提供准确、可靠的检测结果。

Objective To explore the comparability of the testing results obtained from different biochemistry equipments and clear the possibility of its clinical acceptability.Methods According to the acceptable error in CLSI EP5-A and EP9-A,the precision estimation for the two biochemical equipments were made.The detection system was adopted as the target system（X） which was composed of OYLMPUS AU600 automatic biochemistry analyzer,meanwhile,Dimension Xpand plus automatic biochemistry analyzer was used as evaluated system（Y）.Two kinds of control sera（normal and abnormal） were analyzed in eight working days and eighty fresh serum samples were inspected in these days including six biochemical items（BUN,CR,UA,AST,CK,LDH）.The relative deviation between the two detection systems was calculated.The comparability of testing results obtained from different equipments was evaluated according to the CLIA′88 standard.Results The systemic errors on most of the results between OYLMPUS AU600 and Dimension Xpand plus were clinically acceptable except individual items including BUN and UA.Conclusions Most of the results tested by two analysis systems are comparable and able to attain the clinical demand,and the reliable results can also be provided by Dimension Xpand plus automatic biochemistry analyzer.