β_2-微球蛋白金标快速检测试剂条的研制

Development of reagent strip for the colloidal gold immunochromatographic assay of β_2-microglobulin

目的研制一种β2-微球蛋白（β2-MG）金标快速检测试剂条。方法以健康人群血清及尿液β2-MG含量均值的1.5倍作为金标检测试剂条的cut-off值。制备胶体金,标记β2-MG单抗并固化于玻璃纤维,将其与抗体包被的硝酸纤维素膜组装成β2-MG金标检测试剂条。用健康者、糖尿病患者和肾病患者的血清及尿液对试剂条的特异性、敏感性、符合性及稳定性进行测试,与全自动生化仪同步检测,进行符合性实验。结果β2-MG金标检测试剂条血清和尿液cut-off值分别为1.5 mg/L和0.27 mg/L。试剂条对血清及尿液检测特异性分别为97.50%、95.00%,检测敏感性为93.33%~96.67%,试剂条重复性好,37℃条件下12 d质量稳定,与免疫比浊试剂的符合率为88.89%~94.93%。结论β2-MG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 reagent strip for colloidal gold immunochromatographic assay（ CGIA） of β2- microglobulin（ β2- MG）. Methods The 1. 5 times of mean value of β2- MG in serum and urine of healthy population would be used as cut- off point. The colloidal gold was prepared and combined with β2- MG monoclonal antibody,and then solidified on glass fiber. The β2- MG monoclonal antibody and sheep antibody of anti- mouse Ig G were enveloped on nitrocellulose membrane. A CGIA of β2- MG was prepared. The serum and urine from healthy population,patients with diabetes,and patients with nephropathy were detected to test the specificity,sensibility,repeatability and stability of the CGIA of β2- MG. The serum and urine from patients with diabetes and patients with nephropathy were tested both by the CGIA of β2- MG and automatic biochemical analyzer to evaluate the coincidence rate of the two kits. Results The results showed that the cut- off point of the CGIA ofβ2- MG were respectively 1. 5 mg / L in serum and 0. 27 mg / L in urine. The specificity of the kit was 97. 50% for serum and95. 00% for urine,the sensibility of that was 93. 33%- 96. 67% for serum and urine. The results was of good repeatability and under the condition of 37 ℃ in 12 d,the quality was stable. The coincidence of the kit with the detection results with immune specific reagent was 88. 89%- 94. 93%. Conclusion β2- MG colloidal gold immunochromatographic assay is specific,sensitive,rapid,simple and convenient,and suitable for popularization and promotion of renal function test reagent.