Watanabe Y, Amino N, Tamaki H, Aozasa M, Tachi J, Endo Y, Miyai K
Clin Chem. 1985 Apr;31(4):634-6.
A sensitive assay procedure for immunoenzymometric assay of serum thyrotropin (TSH) was developed by making several modifications of the Enzymun-Test TSH kit (Boehringer, Mannheim GmbH). Serum samples were first incubated in plastic tubes precoated with monoclonal antibodies specific to the beta subunit of human TSH. After the tubes were washed, the TSH bound to the tubes was detected with peroxidase-conjugated polyclonal antibodies to TSH. The sensitivity of the assay was 0.2 milli-int. unit/L, and the intra-and interassay CVs were less than 10%. Analytical recovery was 96 to 106%. The normal basal range of TSH was 0.5 to 4.8 milli-int. units/L. The basal levels of TSH in all but one of 48 thyrotoxic patients with Graves' disease were less than 0.2 milli-int. unit/L, clearly different from those of normal subjects. Thyrotoxic patients in early normal pregnancy showed TSH concentrations of 1.7 to 2.9 milli-int. units/L by conventional double-antibody radioimmunoassay, possibly from cross reactivity with human choriogonadotropin, but undetectable TSH by this method. Measurement of basal TSH by this sensitive assay can be used as an initial screening test for thyroid dysfunction.
通过对酶免疫检测促甲状腺激素（TSH）试剂盒（德国曼海姆勃林格殷格翰公司）进行多项改进，开发出了一种灵敏的血清促甲状腺激素免疫酶测定方法。血清样本首先在预包被有针对人TSHβ亚基的单克隆抗体的塑料管中孵育。试管洗涤后，用与TSH结合的过氧化物酶偶联多克隆抗体检测结合在试管上的TSH。该检测方法的灵敏度为0.2毫国际单位/升，批内和批间变异系数均小于10%。分析回收率为96%至106%。TSH的正常基础范围为0.5至4.8毫国际单位/升。48例格雷夫斯病甲状腺毒症患者中，除1例外，其余患者的TSH基础水平均低于0.2毫国际单位/升，与正常受试者的水平明显不同。正常妊娠早期的甲状腺毒症患者，通过传统的双抗体放射免疫测定法，TSH浓度为1.7至2.9毫国际单位/升，这可能是由于与人绒毛膜促性腺激素的交叉反应所致，但用该方法检测不到TSH。通过这种灵敏的检测方法测定基础TSH可作为甲状腺功能障碍的初步筛查试验。
