【Product Name】Detection Kit for human thyroid-stimulating hormone (hTSH) (Enhanced chemiluminescence immunoassay)

【registration certificate number】 京食药监械（准）字2014第2400137号

         This kit is mainly used for quantitative determination of thyroid-stimulating hormone (TSH) in human serum in vitro.

The secretion of thyroid-stimulating hormone (TSH) is regulated by the negative feedback of the concentrations of T3 and T4 in serum. TSH acts mainly on the thyroid gland, which increases synthesis of thyroid and secretion of thyroid hormones T3 and T4. Determination of the content of TSH in serum, is one of the important indicators to diagnose the function of thyroid and study the hypothalamus-pituitary-thyroid axis. In the assessment of thyroid function, primary and secondary (pituitary or hypothalamic) hypothyroidism can be identified and can be used as an

indicator to observe the efficacy of hypothyroidism. In addition, the storage function of pituitary TSH can be observed to further distinguish the lesions of hypothalamus and pituitary; the combination with T4 is the only way to diagnose congenital hypothyroidism in neonates.

 The kit uses a sandwich method. Microplates were coated with one antibody to make a solid-phase antibody and the other labeled with HRP into HRP-antibody. TSH (standard or test sample) and HRP-antibody are added to the wells coated with the antibody to form a complex called antibody-antigen-HRP labeled antibody. The unbound HRP-antibody was removed after the immunoreaction, the value of luminescence (RLU value) was measured with a photon counter after adding the luminescent substrate. With the increase of TSH concentration, the value of RLU gradually increases and keep a linear relation. The instrument software will automatically calculate the TSH content of the sample.

Clinical laboratory, physical examination center.