肿瘤标志物CA125免疫放射分析试剂盒的研制
Development of Immunoradiometric Assay Kit for Tumour Marker CA125
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摘要: 采用两株CA125单克隆抗体,一株用于125I标记,另一株包被于试管作为固相抗体,稀释卵巢癌患者腹水制备标准品,建立了双位点夹心法人血清肿瘤标志物CA125免疫放射分析法。标准曲线的最大标准点免疫结合与零标准非特异结合之比大于100;最小检测限为1.0U/mL;批内、批间变异系数分别为4.4%~5.8%和8.4%~9.9%;样品中加入已知量CA125测定,回收率为96.8%~112.5%;对含高浓度CA125的血清样品稀释测定,结果表明方法的健全性良好。38例健康女性血清样品测定值范围为2.9~24.1U/mL;x±2s为9.6±9.6U/mL。Abstract: A twosite sandwich immunoradiometric assay for quantifying CA125 in serum is developed by using two monoclonal antibodies. One of the antibodies is labeled with 125I as a tracer and the other recognizing a different antigenic determinant of the CA125 molecule is immobilized to plastic tubes as the solid phase. The standards are prepared from the abdominal fluid of ovarian cancer patients. The ratio of the maxium dose binding and nonspecific binding of the standard curve is more than 100.The sensitivity of the assay is 1.0 U/mL and the recovery of added CA125 is 96.8%~112.5%. The intra and interassay CVs are 4.4%~5.8% and 8.4%~9.9% respectively. The correlation coefficients between measured and expected values are more than 0.99 after dilution of the samples with high concentrations of CA125. The value for female normal samples(n=38) is 2.9~24.1 U/mL.