微流控技术ACR检测试剂方法学比对研究  

Methodological Comparison Study of ACR Detection Reagents with Microfluidics Technology

作　　者：沃燕波 刘会永 WO Yanbo;LIU Huiyong(Ali Biotechnology Taizhou Co.,Ltd.,Taizhou,Jiangsu 225300)

机构地区：[1]阿里生物技术泰州有限公司,江苏泰州225300

出　　处：《智慧健康》2023年第22期27-30,共4页Smart Healthcare

摘　　要：目的通过方法学比对分析,探讨微流控和全自动生化分析两种不同检测系统测定尿白蛋白与尿肌酐比值是否具有可比性。方法参照EP9-A2文件,将微流控技术作为实验方法,以全自动生化分析检测系统为比较方法,对40份尿液样本中的尿白蛋白与尿肌酐比值进行测定,连续测定5d,每天按正反序测定8份样本,每份样本重复测定2次。判断离群值及选择的检测范围是否适合,对两方法的测定结果进行线性回归分析,并对其偏倚进行评估。结果本次实验没有离群值,相关系数r=0.9964,两方法的线性回归方程为y=0.6631+0.9866x,预期偏差95%可信区间上限为0.8672mg/mmoL,允许偏倚为1.7mg/mmoL,允许误差大于预期偏差可信区间的上限。结论两种方法测定尿白蛋白与尿肌酐比值的结果具有良好的可比性和相关性。Objective To explore comparability of two different detection systems of microfluidics and automatic biochemical analysis in detection of urinary albumin to creatinine ratio based on methodological comparison and analysis.Methods Microfluidics technology was used as experimental method with reference to EP9-A2 document,the paper detected urinary albumin to urinary creatinine ratio of 40 urine samples with comparative method of automatic biochemical analysis and detection system,continuously for 5 days.8 samples were detected in positive and reverse order every day,each sample was repeated twice,to determine suitability of outliers and selected detection range,linear regression analysis on measurement of two methods was carried out,to evaluate the bias.Results There were no outliers in the experiment,with correlation coefficient of r=0.99964.Linear regression equation for two methods was y=0.6631+0.9866x,upper limit of 95%confidence interval for expected deviation was 0.8672 mg/mmol.Allowable bias was 1.7 mg/mmol,allowable error was higher than upper limit of confidence interval for expected deviation.Conclusion Measuring results of urinary albumin to urinary creatinine ratio with two methods have good comparability and correlation.

关 键 词：微流控技术 尿白蛋白与尿肌酐比值 方法比对 偏倚评估 

分 类 号：R446.12[医药卫生—诊断学]