日立生化分析仪检测尿微量白蛋白结果评价与分析条件

Result Evaluation and Analytical Conditions of Microalbuminuria Determination by Hitachi Automatic Chemistry Analyzer

目的研究生化分析仪在不同分析条件下检测尿微量白蛋白(MAU)的差异。方法基于全自动生化分析仪,以CLSI EP9-A2和EP7-A2方案为基础,设计3种检测方法(方法1:血、尿样本同批随机分析;方法2:尿样单独批次分析;方法3:批尿样插入血样同批分析)测相同样本中的MAU,并对检测数据进行统计学分析。结果与特定蛋白分析数据比较:方法1所得结果差异有统计学意义(P<0.001,r=0.968 2,偏倚=40.9);方法2所得结果差异无统计学意义(P>0.05,r=0.998 9,偏倚=0.8);方法3结果显示血清样本对后续多个MAU检测存在严重携带交叉污染,污染率最高可达341.3%。结论根据临床医学决定水平和CLIA’88(2003)及EP7-A2要求,方法1可能会误导临床诊断和治疗;方法3显示系统携带交叉污染会对后续多个检测结果造成干扰;方法2可满足临床应用要求。

Objective To compare the results of microalbuminuria（MAU） determination with automatic chemistry analyzer under different analytical conditions.Methods The same specimens were used for MAU determination with a Hitachi automatic chemistry analyzer according to CLSI EP9-A2 and EP7-A2 by three detection methods：1） the random analysis of blood and urine samples in a same batch;2） the separate batch analysis of urine samples;3） the same batch analysis of blood samples by inserting urine samples.The data were statistically analyzed.Results Results achieved by method 1 were significantly different from the specific protein analysis data（P〈0.001,r=0.968 2,bias=40.9）,but there were no obvious differences in results between method 2 and specific protein analysis（P〉0.05,r=0.998 9,bias=0.8）.Results achieved by method 3 showed serious cross-contamination in serum specimens（maximum contamination rate,341.3%）.Conclusion According to medical decision level,CLIA’88（2003） and EP7-A2,method 1 for MAU determination may mislead clinical diagnosis and treatment;method 2 for MAU determination may interfere with subsequent detection;method 3 for MAU determination can meet the requirements of clinical application.