干化学与湿化学分析系统常规生化项目检测结果可比性分析

Comparability of routine biochemical indexes between dry chemistry and wet chemistry analysis systems

目的探讨干化学和湿化学分析系统常规生化项目检测结果的可比性。方法根据美国临床实验室标准化协会(CLSI)EP15-A2文件要求,选择中值和高值2个浓度的质控品,分别采用AU 5800全自动生化分析系统和VITROS 5600全自动生化免疫分析仪2个生化分析系统进行重复性精密度和中间精密度检测。以AU 5800全自动生化分析系统为比对系统,以VITROS 5600全自动生化免疫分析仪为实验系统,将2个分析系统18项常规生化项目检测结果进行回归分析,得到直线回归方程和r值,评估2个分析系统的预期偏移。结果2个生化分析系统的重复性精密度和中间精密度均低于实验室的精密度要求。18项常规生化检测项目中,除乳酸脱氢酶外,其他17项r^2均>0.95。γ-谷氨酰基转移酶、总胆红素、尿酸、氯、钙、二氧化碳、血糖和总蛋白8项在医学决定水平处的偏移可接受;丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、乳酸脱氢酶和肌酐4项在医学决定水平处的偏移不可接受;碱性磷酸酶、尿素、肌酸激酶、钾、钠和白蛋白6项在医学决定水平处的偏移部分可接受。结论湿化学和干化学2个生化分析系统绝大部分项目检测结果相关性良好,但仍有偏移不可接受的项目,有必要针对不同的方法建立不同的参考区间。

Objective To investigate the comparability of routine biochemical indexes between dry chemistry and wet chemistry analysis systems.Methods The within-run precisions and intermediate precisions for middle and high values of quality control materials were determined by AU 5800 automatic biochemical analyzer and VITROS 5600 automatic biochemical immune analyzer.According to the Clinical and Laboratory Standards Institute(CLSI)document EP15-A2,AU 5800 automatic biochemical analyzer was used as comparative system,and VITROS 5600 automatic biochemical immune analyzer was used as experimental system.Totally,18 routine biochemical indexes were determined by the 2 systems.The correlation and bias between the comparative system and experimental system were evaluated and calculated by linear regression analysis.Linear regression equation and r were obtained,and the bias between the 2 systems was evaluated.Result The within-run precisions and intermediate precisions for the 18 routine biochemical indexes were all lower than precision requirement.Except for lactate dehydrogenase,the other indexes showed good correlations between the 2 systems(r^2>0.95).The biases for gamma glutamyltransferase,total bilirubin,uric acid,Cl,Ca,CO2,glucose and total protein were acceptable.The biases for alanine aminotransferase,aspartate aminotransferase,lactate dehydrogenase and creatinine were unacceptable.The biases for alkaline phosphatase,urea,creatine kinase,K,Na and albumin were acceptable at certain concentrations.Conclusions AU 5800 automatic biochemical analyzer and VITROS 5600 automatic biochemical immune analyzer display good correlation.The biases for a part of indexes are acceptable.It is necessary to establish the different reference intervals aiming at different methods.