新的尿微量白蛋白测定试剂的研制及评估

The Research and Evaluation of a New Kit for Determination of Microalbumin

目的:研制以金标斑点免疫渗滤法定量测定尿微量白蛋白的快速诊断试剂,并初步考察其临床适用性。方法:研究建立以双抗夹心法为基础的胶体金标记检测模式,将其与免疫比浊法比较,统计两种方法的一致性。结果:所建立的金标斑点免疫渗滤法在20～200mg/LALB范围内线性良好,r=0.998 1,与尿液中常见化学成份无交叉反应,批内批间精密度分别为11.24%和10.73%,测定结果与免疫比浊法相比无统计学差异,相关性良好(r=0.976 2,P>0.05)。结论:本文研制的金标斑点免疫渗滤法试剂完全能够满足临床上尿微量白蛋白的测定需要,与免疫比浊法相关性良好,操作快速简便。

Objective：Research for a rapid quantitative determination microalbuminuria test by DIGFA method and eveluate the clinical application.Methods：An Immunoassay determinated by colloidal gold which based on sandwich-format was established and compared with immunoturbidmetry to estimate the concordance of these two methods.Results：The linearity during 20-200mg/L of the new method was good,r=0.998.There has no interference with normal component of urine.The precision of its intra and extra assay was 11.24% and 10.73%.There was no statistical difference between two methods and the relativity was good（r=0.9762,P〉0.05）.Conclusions：This kit can meet the demand of clinical application.It has good relativity with immunoturbidmetry and the measure was convenient.