干化学与湿化学分析仪的可比性分析

Comparability analysis between dry chemistry analyzer and wet chemistry analyzer

目的探讨不同生化分析仪16项常规生化指标测定结果的可比性。方法参照美国临床实验室标准化委员会(NCCLS)EP9-A2文件,以贝克曼DXC800全自动生化分析仪为参比系统,以强生VITROS5600全自动生化免疫分析仪为待比系统,用患者新鲜血清分别在2台仪器上检测16项常规生化指标,检查离群点,计算相关系数和直线回归方程,评估2个系统的预期偏差,并以美国临床实验室改进修正案(CLIA′88)对室间评估的允许误差的1/2为判断依据,对强生VITROS5600干化学系统的临床可接受性进行评价。结果参比系统与待比系统具有良好的相关性,除丙氨酸氨基转移酶(ALT)、乳酸脱氢酶(LDH)、肌酐(Crea)及部份医学决定水平处天门冬氨酸氨基转移酶(AST)、总钙(Ca)、血清总蛋白(TP)测定结果的偏差外,其余指标测定结果的偏差临床均可接受。结论强生VITROS5600干化学分析仪与Beckman DXC800全自动生化分析仪的检测结果具有可比性,但ALT、AST、LDH、Ca、Crea、TP临床比对多水平处的偏差不可接受,仍有必要针对不同方法建立不同的参考区间。

Objective To investigate the comparability of the results of 16 routine biochemical indexes detected by different biochemical analyzers.Methods With the Beckman DXC800 automatic biochemical analyzer as the reference system and the VITROS5600 automatic biochemical immune analyzer as the compared system according to the EP9-A2,guideline established by NCCLS.The 16 routine biochemical indexes were detected in serum of patients by the two instruments.The clinical acceptability of the VITROS5600 dry chemistry system was evaluated according to the judgment basis of 1/2allowable error of the external quality assessment in CLIA′88standard.Results The reference system and the compared system had better comparability.All tests showed good correlation between the two analytical systems.The biases of all tests were clinically acceptable,except for ALT,LDH,Crea,AST,Ca and TP.Conclusion The VITROS5600 dry chemical instrument could have good comparability with the Beckman DXC800 automatic biochemical analyzer.But the biases of ALT,AST,LDH,Ca and Crea and TP in the clinical comparison at multiple levels were not acceptable.It is necessary to establish the different reference ranges aiming at different methods.