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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 cystatin C (Cys-C) gold standard rapid detection reagent strip. Methods The serum Cys-C cut-off value of early renal injury was determined. The lowest detection value was 0.9μg / ml. Colloidal gold was prepared by the trisodium citrate reduction method, the Cys-C monoclonal antibody was labeled with a colloid and cured on a glassy cellulose pad, and a nitrocellulose membrane was coated with a Cys-C monoclonal antibody and a goat anti-mouse Ig G antibody to prepare Cys-C immunochromatographic gold standard test strips. 175 serum samples from diabetic patients, 418 serum samples from nephropathy patients and 102 healthy human serum samples were tested using reagent strips to test the specificity, sensitivity, compliance and stability of the strips. Results The specificity of the kit was 93.33%, the positive rate of Cys-C in diabetes was 77.71%, the positive rate of Cys-C in nephropathy was 85.88%, the positive rate of Cys-C in both groups was significantly higher than that in healthy people, The difference was statistically significant (P <0.01). Repeatability and stability test results showed that the reagent test results reproducibility, 12 d under 37 ℃ quality and stability. Conclusion Cys-C gold standard test strip is a specific, sensitive, fast, simple, suitable for universal promotion of renal function testing reagents.