[Development of monoclonal antibody-based immunoenzyme kit for detection of human thyrotropin hormone]

An enzyme immunoassay kit based on monoclonal antibodies (Mab) has been developed for measuring thyroid-stimulating hormone in human serum and plasma. Laboratory trials demonstrated its high sensitivity (3.1 microIU/ml), specificity, reliability, and accuracy. The analysis is simple and rapid (2.5 h), which is convenient for clinical use. The kit permits differentiation between normal subjects and patients with primary hypo- or hyperthyroidism and helps monitor the treatment efficacy. Comparison with the Amerlite TSH-60 kit, carried out on 357 sera, showed a high correlation coefficient (0.96) between the two kits.