β2-微球蛋白酶联免疫分析试剂盒的研制

以β₂-微球蛋白（β₂-MG）抗体包被微孔板，四甲基联苯胺（TMB）为底物，用辣根过氧化物酶标记β₂-MG，建立了β₂-微球蛋白酶联免疫分析试剂盒，并对该方法进行了方法学分析。结果显示：本方法分析灵敏度为0.15 mg/L，批内、批间变异系数分别为4.1％～11.2%和14.1％～16.0％，回收率为93.3%～115.9%，高浓度β₂-MG样品系列倍比稀释后，测定值与稀释度呈线性相关，相关系数为r=0.997 4。特异性结果显示：本试剂盒与铁蛋白基本无交叉反应，与白蛋白及甲胎蛋白在浓度分别低于10 mg/L及5 mg/L时有交叉反应，但反应很小。与放射免疫分析法（RIA）同时测定人血清样品，方法间有良好的相关性，相关方程为y_ELIA=1.006x_RIA+0.406，r=0.900(n=59)。以上参数均符合临床免疫分析的要求。本试剂盒操作简便、快速，适用于临床检测和科研应用。

Establishment of an Enzyme Linked Immunosorbent Assay for β2-Microglobin

A sensitive and specific ELISA for β2-Microglobin was established by using anti- β2-Microglobin antibody coated on the microtiter plate, and β2-Microglobin labeled horse- radish peroxidase（HRP）. TMB-H2 02 solution was used as the substrate of HRP. The sensi- tivity of the assay is 0. 15 mg/L. The intra- and inter-assay CVs were 4.06%-11.2% and 14.1%-16.0%, respectively. The analytical recovery was 93.3%-115.9%, the coefficient correlation was 0. 997 4. The assay is specific for β2-MG and no cross reaction with Fer, lit- tle cross reaction with albumin and u-fetoprotein when it is below 10 mg/L and 5 mg/L, re- spectively. For a reference RIA method, the correlation regression equation of present method is yELISA =1-006ZVRIA＋0. 406, r=0. 900（n=59）. This method for measuring β2-MG is rapid, sensitive and convenient. It is suitable for clinical and research application.