人胱抑素C金标快速检测试剂条的研制  

Development of colloidal gold immunochromatographic assay strip for the rapid detection of Cystatin C

作　　者：杜惠芬[1] 李克生[1] 李光迪[2] 江秀娟[3] 徐杨[1] 柴丹丹[1] 

机构地区：[1]甘肃省医学科学研究院医学生物技术研究中心,甘肃兰州730050 [2]兰州大学第二医院检验医学中心,甘肃兰州730050 [3]甘肃省肿瘤医院检验输血科,甘肃兰州730050

出　　处：《中国卫生检验杂志》2016年第24期3517-3519,共3页Chinese Journal of Health Laboratory Technology

基　　金：甘肃省科技支撑计划(1204FKCA178)

摘　　要：目的研制一种胱抑素C(Cys-C)金标快速检测试剂条。方法确定早期肾损伤的血清Cys-C cut-off值,以0.9μg/ml为试剂条最低检测值。用柠檬酸三钠还原法制备胶体金,用胶体标记Cys-C单克隆抗体并固化于玻璃纤维素垫,用Cys-C单克隆抗体和羊抗鼠Ig G抗体包被硝酸纤维素膜,制备Cys-C免疫层析金标检测试剂条。用试剂条检测175份糖尿病患者血清样本、418份肾病患者血清样本和102份健康人血清样本,对试剂条的特异性、敏感性、符合性及稳定性进行测试。结果试剂盒的特异度达到93.33%,糖尿病患者血清Cys-C阳性率为77.71%,肾病患者血清Cys-C阳性率为85.88%,两类患者血清Cys-C阳性率均显著高于健康人群,差异有统计学意义(P<0.01)。重复性和稳定性试验结果显示试剂检测结果的重复性好,37℃条件下12 d质量稳定。结论 Cys-C金标检测试剂条是一种特异性强、敏感性高、快速、简便,适宜普及推广的肾功能检测试剂。Objective To develop a colloidal gold immunochromatographic assay（ CGIA） strip for the rapid detection of Cystatin C（ Cys-C）. Methods The serum Cys-C cut-off value of early renal injury was determined,with the lowest detection value as 0. 9 μg / ml. Colloidal gold was prepared by deoxidizing reaction of trisodium citrate,and was combined with Cys-C monoclonal antibody. The combo of colloidal gold and Cys-C monoclonal antibody was solidified on glass cloth. Cys-C monoclonal antibody and goat anti-mouse Ig G were enveloped on nitrocellulose filter. A CGIA strip of Cys-C was prepared. The specificity,sensibility,repeatability and stability of the CGIA strip of Cys-C were tested in serum from 175 patients with diabetes,serum from 418 patients with nephropathy and serum from 102 healthy individuals. Results The results showed that the specificity of the CGIA strip of Cys-C was 93. 33%,the positive rate of Cys-C was 77. 71% in patients with diabetes,and85. 88% in patients with nephropathy,the serum Cys-C positive rates between the two groups were significantly higher than that of healthy population,and the difference was statistically significant（ P 0. 01）. Repeatability and stability tests showed that test results had higher repeatability,and the strip can be steadily stored for 12 days at 37℃. Conclusion CGIA strip of Cys-C was a specific,sensitive,rapid and convenient detection agent for renal function,and was suitable for popularization.

关 键 词：胱抑素C 金标检测 试剂条 研制 

分 类 号：R97[医药卫生—药品]