胶乳增强免疫比浊法检测尿液中α1-微球蛋白的含量

摘要

Objective: The comprehensive performance of self-developed urine alpha 1 -microglobulin (α1-MG) testing kit was evaluated and compared with imported reagents kit for clinical samples. Methods: The method is detecting the content of trace α1-MG in urine by the test kit, which included reagents R2 and R1. The reagents R2 of the test kit contained stabilizer and latex particles, which is packaged on the polyclonal antibody of α1-MG. The main component of the reagents R1 of the test kit was suitable buffer system, sensitization agent and stabilizer. Evaluation of the detection performance of the test kit was completed, including calibration curve, stability, interference test, and recovery rate, detecting the content of urinary α1-MG in 101 patients with kidney disease. Results:The measurement range of the test kit is 2.0~160 mg/L, and the recovery is 94.0%~106.0%. Testing the different concentrations of clinical samples(n=20), the coefficient of variation is less than 5.0%. Compared with the imported reagent from Japan, the correlation coefficient of 101 clinical samples is 0.9854. Conclusion: The test kit with fine repeatability, veracity and wide measurement range can be used for clinical detection ofα1-MG in urine.%目的：对自主研制的尿α1-微球蛋白(α1-MG)检测试剂盒进行综合性能评价，并与进口试剂进行临床对比。方法：采用尿α1-MG检测试剂盒，对收集的101例肾病患者晨尿进行α1-MG的含量检测。将α1-MG的多克隆抗体包被在胶乳微粒上，添加相应的稳定剂得到试剂R2，采用适合的缓冲体系、增敏剂及稳定剂得到试剂R1。评价由试剂R1和试剂R2组成试剂盒的定标曲线、稳定性、干扰试验及回收率等检测性能。结果：试剂盒的测量范围在2.0～160 mg/L，回收率为94.0%～106.0%，对不同浓度的临床样本测试20次，其变异系数(CV)＜5.0%；与日本进口试剂相比较，测试临床标本101例，其相关系数r2＝0.9854。结论：该试剂盒具有良好的准确性和重复性，线性范围宽，符合临床检测需要，可用于尿液中α1-MG的含量检测。