贝克曼AU5800自建系统与配套系统检测结果的比对分析

Comparability Analysis of Test Results Between Non-matching Reagents and Matching Reagents on Beckman AU5800 Analyzer System

目的探讨多种国产试剂在贝克曼AU5800全自动生化分析仪上与配套试剂测定结果的一致性。方法贝克曼AU5800与上海科华、荣盛、玉兰品牌试剂组成自建系统,根据美国临床标准化委员会EP9-A2文件要求,收集40份标本,分别在贝克曼AU5800自建系统与配套系统上对Alb(白蛋白)、TP(总蛋白)、GGT(谷氨酰转肽酶)、AST(天门冬氨酸氨基转移酶)、ALT(丙氨酸氨基转移酶)、TG(甘油三酯)、UA(尿酸)、BUN(尿素氮)、PHOS(磷)、CK(肌酸激酶)、ALP(碱性磷酸酶)、CREA(肌酐)、CHOL(总胆固醇)、LDL(低密度脂蛋白)、HDL(高密度脂蛋白)、GLU(糖)共16个项目进行检测,对检测结果进行线性回归分析及偏倚评估来评价两系统是否具有可比性。结果两检测系统的所有项目相关系数r2均大于0.95,除GGT、PHOS在2U/L、0.48mmol/L上各自医学决定水平处的偏倚大于1/2CLIA’88允许总误差外,其于各项目均小于1/2CLIA’88允许总误差,表明两系统检测结果具有较好的一致性。结论在贝克曼AU5800全自动生化分析仪上国产试剂组成的自建系统与配套系统具有可比性,属临床可接受标准。

Objective To investigate the coincidence of the results between multiple domestic reagents and Beckman reagent on Beckman AU5800 automatic biochemical analysis system. Methods According to the NCCLS EP-9 Second Edition document,40 samples were collected and the levels of ALb,TP,GGT,AST,ALT,TG,UA,BUN,PHOS,CK,ALP,CREA,CHOL,LDL,HDL and GLU were determined by the nonmatching system using Shanghai Kehua,Rongsheng and Yulan reagents and matching system using Beckman reagent at the same time on Beckman AU5800 automatic biochemical analyzer. The results were analyzed by linear regression analysis method. Results The correlation coefficient of two analysis system results on all detected items were greater than 0. 95,except that the bias of items of GGT and PHOS at the 2 U / L and 0. 48 mmol / L medical decision level were greater than half of CLIA＇88 allowable total errors,and all others were lower than half of CLIA＇88. There was good coincidence on testing results between non-matching and matching system. Conclusion The non-matching system using domestic reagents on Beckman AU5800 automatic biochemical analyzer could be accepted for clinical application.