目的建立一种低成本、高灵敏度的检测血清促甲状腺激素(TSH)的生物素-亲和素酶促化学发光免疫分析方法。方法引入生物素-亲和素放大系统，一株抗TSH的单克隆抗体包被微孔板，另一株标记生物素，辣根过氧化物酶标记链亲和素，鲁米诺作为发光底物，采用夹心法，建立TSH酶促化学发光免疫分析方法。结果方法分析灵敏度为0.01mIU/L，批内变异系数为2.01%～5.40%，批间变异系数为2.96%～17.9%，回收率为90.6%～114.4%，高值促甲状腺激素血清样品经系列倍比稀释后，测定值与稀释度呈线性关系，相关系数大于0.99，与原子高科TSH免疫放射分析方法和罗氏电化学发光分析法的测定值具有良好的相关性。结论生物素-亲和素TSH酶促化学发光免疫分析方法具有成本低、灵敏度高、特异性高和稳定性好的特点，具有广阔的应用前景。

Objective To establish a low-cost and high-sensitivity chemiluminescence immunoassay for thyroid stimulating hormone in human serum by using biotin-avidin system.Methods Two monoclonal antibodies of TSH were used in the assay. One was coated on the microtiter plate and the other was biotinylated. The streptavidin labeled horse radish peroxidase, luminol and hydrogen peroxide were used in this system to establish the assay. Results The assay sensitivity of the method was 0.01mIU/L. The intra-assay and inter-assay coefficients of variation were 2.01%-5.40% and 2.96%-17.9%, respectively. The analytical recovery was 90.6%-114.4%. The correlation coefficients were beyond 0.99 after serial dilutions of two samples with high concentration of TSH. The examination result of the assay correlates well with that of IRMA and Roche ECLIA. Conclusion The chemiluminescence immunoassay of biotin-avidin TSH established in this study is low-cost, sensitive, specific and stable. It may have a promising prospect in clinical application.