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采用抗ｈＴＳＨ单抗８Ｅ７包被聚苯乙烯４０孔板作为固相抗体，另用高滴度的兔抗ｈＴＳＨ多抗作液相抗体，以辣根过氧化物酶标羊抗兔ＩｇＧ作为标记第二抗体为反应的显示系统，以邻苯二胺作底物，４５０ｎＭ吸收值计算ｈＴＳＨ浓度，建立了高灵敏度的ｈＴＳＨ酶免吸附测定法（ＥＬＩＳＡ）。灵敏度为０．０３ｍＩＵ／Ｌ。批内ＣＶ１．４～６．７％平均５．４％（ｎ＝２０）批间ＣＶ为７．０％。方法特异性鉴定显示与其他糖蛋白激素无明显的交叉反应性。添加回收及稀释度试验鉴定均表明方法重复性、准确性、线性相关都符合临床应用标准。应用本法与瑞士Ｓｅｒｏｎｏ公司出品的酶免磁颗粒分离药盒同时测定１３０例，相关系数为０．９３。
Using anti-hTSH monoclonal antibody 8E7 coated polystyrene 40-well plate as a solid phase antibody, the other high-titer rabbit anti-hTSH polyclonal antibody as liquid phase, horseradish peroxidase labeled goat anti-rabbit IgG as a marker The second antibody was the reaction display system. The o-phenylenediamine was used as the substrate, and the hTSH concentration was calculated at 450nM absorbance to establish a high-sensitivity hTSH enzyme-free adsorption assay (ELISA). Sensitivity of 0.03mIU / L. Intra-assay CV1.4 ~ 6.7% Average 5.4% (n = 20) Intra-assay CV was 7.0%. Method-specific identification showed no significant cross-reactivity with other glycoprotein hormones. Add recycling and dilution test showed that the method repeatability, accuracy, linear correlation are in line with clinical application standards. Application of this method and the Swiss company Serono enzyme-free magnetic particle separation kit for the simultaneous determination of 130 cases, a correlation coefficient of 0.93.