Abstract:
The chemiluminescence immunoassay for thyroid stimulating hormone in human serum was developed. Two monoclonal antibodies of TSH were used in the assay, one of which was labeled with horseradish peroxidase (HRP) and the other was coated on the microtiter plate. Luminol was used as the substrate of HRP and hydrogen peroxide was introduced into this system. The standard range of the method is 0.1-100 mIU/L. The assay sensitivity is 0.04 mIU/L. The intra and inter-assay coefficients of variance are 3.98%-6.48% and 4.61%-13.1%. Analytical recovery is 95.8%-117.4%. The correlation coefficient between measured and expected values is more than 0.99. The cross reaction rate with LH is less than 1.62%, and that with FSH and HCG is less than 0.05% and 0.02%, respectively. Compared with determine value clinically in chemiluminescence immunoassay (CLIA) kit from Roche company, the correlative equation is
y=1.10
x-0.207, and correlation coefficient is 0.969. Compared with immunoradiometric assay (IRMA) kit, the correlative equation is
y=1.00
x+0.191, and correlation coefficient is 0.965. This method is rapid and convenient, and it is suitable for clinical and research application.