尿微量白蛋白荧光免疫层析定量检测试剂的研制及性能评价

发布时间：2018-12-20 06:42

【摘要】：旨在建立一种快速定量检测人尿液中微量白蛋白的荧光免疫层析方法。以羧基荧光微球标记的抗人白蛋白单克隆抗体及羊抗兔Ig G为标记抗体,人白蛋白和兔Ig G分别作为检测线和质控线制备荧光免疫层析试纸条。结果显示,所制备检测试剂的线性范围为5-300 mg/L,检测限为2.3 mg/L,批内和批间变异系数(CV)分别为6.4%-9.3%和6.5%-12.3%,平均回收率为102.3%。试剂与尿液中20种干扰物质无交叉反应,实时稳定性试验表明试剂盒有效期12月。临床样本测试,与Orion Quik Read U-ALB试剂相关性较好(r=0.993,P0.01),Bland-Altman分析表明两种方法的诊断结果具有较好的一致性。所制备的荧光免疫层析检测试剂提供了一种简单、快速、准确的定量检测尿液中微量白蛋白的方法。
[Abstract]:To establish a rapid and quantitative method for the determination of microalbumin in human urine by fluorescence immunochromatography. Using carboxyl fluorescent microspheres labeled monoclonal antibody against human albumin and sheep anti-rabbit Ig G as labeling antibody, human albumin and rabbit Ig G were used as detection line and quality control line respectively to prepare fluorescent immunochromatographic test strip. The results showed that the linear range of the prepared reagent was 5-300 mg/L, and the detection limit was 2.3 mg/L,. The coefficient of variation (CV) was 6.4% -9.3% and 6.5% -12.3%, respectively. The average recovery was 102.3%. There was no cross-reaction between the reagent and 20 kinds of interfering substances in urine. The real-time stability test showed that the kit was valid for 12 months. There was a good correlation between the clinical samples and Orion Quik Read U-ALB reagent (r 0.993U P0.01). Bland-Altman analysis showed that the diagnostic results of the two methods were in good agreement. The fluorescent immunochromatographic assay provides a simple, rapid and accurate method for quantitative determination of trace albumin in urine.
【作者单位】：广州万孚生物技术股份有限公司自检型快速诊断国家地方联合工程实验室;华南理工大学食品科学与工程学院;
【基金】：国家科技支撑计划资助项目(2012BAI19B05) 广州市科技计划资助项目(201503020003)
【分类号】：R392-33

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