糖类抗原CA19-9免疫放射分析法的建立

Development of a CA19-9 Immunoradiometric Assay

  • 摘要: 采用两株CA19-9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,用血清稀释CA19-9抗原,制备标准品 ,建立了CA19-9双位点夹心免疫放射分析方法(IRMA) 。分析采用两步法,本方法最小检测限为2.0 U/mL,批内、批间变异系数分别为 6.4%~9.5%和6.0%~12.6%, 样品添加实验结果显示,回收率为88.1%~106.1%,血清样品倍比稀释后测定,测定值和稀释度的相关系数为0.990。CA19-9浓度至11800 U/mL时测定未见“弯钩”效应。69例健康人血清样品测定值为0.3~29.6 U/mL( ±s 为7.4±5.8 U/mL),和 法国CIS公司 的CA19-9免疫放射分析药盒同时测定84例人血清样品,二者测定值相关方程为y=1.32x-17.6,相关系数r=0.896。

     

    Abstract: An IRMA for determination of CA19-9 in human serum based on two monoclonal antibodies are developped, one of which is coated on polystyrene tubes as solid phase and another labelled with 125I as the tracer. Two-step assay procedure is employed and mouse IgG is used to block heterophilic antibody interference. The intra- and inter- assay of the IRMA are 6.4%~9.5% and 6.0%~12.6% respectively, the detection limit of the assay is 2.0 U/mL, and recovery is 88.1%~106.1%. The results of dilution test demonstrate good correlation between dilution times and values (r=0.990).

     

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