研制人血清中TSH的化学发光免疫检测试剂盒研究

Study on the chemiluminescence immunoassay kit for the development of TSH in human serum

目的研究研制人血清中TSH的化学发光免疫检测试剂盒。方法选取有辣根过氧化物酶标记的抗TSHp亚单位特异性单克隆抗体（mAb），与抗TSH13亚单位的另一个mAb相配对，使用鲁米诺做底物，采取两步法建立起双位点夹心法来进行研制人血清中TSH的化学发光免疫检测试剂盒。结果这种检测方法具有较好的灵敏度，其中批内的CV平均是4．7％，批问的平均CV是8．4％。本次检测实验与LH、FSH及HCG都没有交叉反应。经过测试部分实验样品，得出该试剂与国外同类试剂测定结果有明显的相关性（r=0．984）。结论实验研究中的检测方法具有较好的灵敏度及准确性，与同类产品相比也相对简便、快捷，花费成本低，在临床检测与科研上值得使用与推广。

Objective To study the chemiluminescence immunoassay kit for the development of TSH in human serum. Methods Horseradish peroxidase labeled anti TSH subunit specific monoclonal antibody （mAb）, and anti TSH subunit of another mAb pairs, using luminol as a substrate, took two steps to establish a two-site sandwich method to carry out research in human serum TSH chemiluminescence immune detection kit. Results This method had a good sensitivity, in which the average intra-assay CV was 4.7%, and the average between- run CV was 8.4%. The detection experiment and LH, FSH, HCG had no cross reaction. After the test part of the experimental samples, the results obtained from the reagent and similar reagents in foreign countries had obvious correlation （r=0.984）. Conclusion The detection method of experimental study has good sensitivity and accuracy, is relatively simple, fast, low-cost compared with similar products, worth to use in clinical testing and research.