Development of chemiluminscence immunoassay kit for follicle-stimulating hormone

The chemiluminescence immunoassay for follicle-stimulating hormone in human serum was developed. Two monoclonal antibodies of FSH were used in the assay, one of which was labeled with horseradish peroxidase(HRP) and the other was coated on the microtite plate. Luminol was used as the substrate of HRP and hydrogen peroxide was introduced into this system. The standard range of the method was 1.5-100 IU/L. The assay sensitivity was 0.36 IU/L. The intra-and inter-assay coefficients of variance were 1.0%-1.6% and 4.0%-4.6% respectively. Analytical recovery was 90.6%-117.8%. The correletion coefficient between measured and expected values was 0.990. The crossreacting rate with TSH was less than 0.23%, and that with LH and HCG less than 0.16% and 0.27%. Compared with determine value clinically in chemiluminescence immunoassay(CLIA) kit from Beckman coulter company, the correlative equation was y=0.85χ-0.03, and correlation coefficient was 0.954. Compared with immunoradiometric assay (IRMA) kit and radioimmunoassay (RIA) kit, the correlative equation were y=0.97χ+5.29 and y=0.95χ-3.82, and their correlation coefficient were 0.965 and 0.954 respectively. (authors)