人血清CA15-3免疫放射分析法的建立

The Establishment of Immunoradiometric Assay for CA15-3 in Human Serum

一株CA15-3单克隆抗体用于125I标记,另一株CA15-3单克隆抗体包被试管作为固相抗体,建立了双位点夹心肿瘤标志物CA15-3免疫放射分析法。CA15-3标准品以CIS公司免疫放射分析药盒标准品校正。最小检测限为0.4U/mL;批内、批间变异系数分别为6.0%～6.2%和4.1%～5.9%;样品中加入已知量CA15-3测定,回收率为86.8%～118.6%;高浓度CA15-3的血清样品系列倍比稀释后测定,实测值和计算值呈线性相关,相关系数大于0.99;38例健康女性血清样品测定值为5.7～23.7U/mL。

A two-site sandwich immunoradiometric assay for quantifying CA15-3 in human serum is established by using two monoclonal antibodies. One of the antibodies is labeled with ^(125)I as a tracer and the other recognizing a different antigenic determinant of CA15-3 antigen is immobilized on poly-styrene tubes as the solid phase. The standards prepared from CA15-3 antigen are corrected against the standards of CIS ELSA CA15-3 IRMA kit. The sensitivity of the assay is 0.4 U/mL and the recovery is 86.8%～ 118.6%. The intra- and inter-assay CVs are 6.0%～6.2 % and 4.1%～5.9%, respectively. The correlation coefficients between measured and expected values are more than 0.99 after serial dilution of the samples with high concentrations of CA15-3. The value for female normal samples (n=38) is 5.7～23.7 U/mL.