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为建立癌胚抗原(CEA)尼龙微球固相免疫放射分析法并应用于临床.采用Lodogen法125Ⅰ标记CEA单克隆抗体C-17,用单克隆抗体C-50、C-6化学包被尼龙微球制成固相抗体(N-SP).建立一步法的CEAN-SPIRMA,灵敏度2μg/L,工作范围为5-80μg/L,批内和批间CV分别为4.63%和8.34%,回收率93.86-104.73%.结果:65例正常人CEA值为5.2±3.8μg/L,78例良性病人为12.3±5.4μg/L,87例恶性肿瘤病人为69.3±51.4μg/L.正常组与良性疾病组比较差异无显著意义(P>0.05);正常组与恶性肿瘤组比较差异有显著意义(P<0.01),以上测定值与CEA放射免疫法结果比较相关系数r=0.9328,P<0.01,且提高了恶性肿瘤诊断率.结论:该方法操作简便、快速、准确,是一种新型有效而实用的分析技术,可推广使用.
To establish carcinoembryonic antigen (CEA) nylon microspheres by solid phase immunoassay and applied to clinical. CEA monoclonal antibody C-17 was labeled with 125 I by Lodogen method and solid-phase antibody (N-SP) was made by coating nylon microspheres with monoclonal antibodies C-50 and C-6. A one-step CEAN-SPIRMA was established with a sensitivity of 2μg / L and a working range of 5-80μg / L. The intra-and inter-assay CV was 4.63% and 8.34%, respectively. The recovery was 93.86-104.73% . Results: The CEA value of 65 normal people was 5.2 ± 3.8μg / L, 78.3% of benign patients were 12.4 ± 5.4μg / L, and 87 cases of malignant tumors were 69.3 ± 51.4μg / L. There was no significant difference between the normal group and the benign disease group (P> 0.05). The difference between the normal group and the malignant tumor group was significant (P <0.01). The correlation between the above values and CEA radioimmunoassay results r = 0.9328, P <0.01, and increased the diagnosis rate of malignant tumors. Conclusion: The method is simple, rapid and accurate. It is a new effective and practical analytical technique that can be used widely.