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TSH ELISA Kit CE certified,IVD use

Thyroid stimulating hormone (TSH) is a glycoprotein with molecular weight ca.30 kDa which is secreted by hypophysis. A molecule of TSH consists of two noncovalently bound subunits: α- and β-HCG. β-subunit determines biological activity and immunological specificity of TSH. TSH stimulates thyroid gland to secrete thyroid hormones. TSH secretion in hypophysis is controlled by a negative feedback regulation by thyroid hormones. TSH secretion is subject to circadian rhythms with highest levels seen early in the morning (6 a.m.). Changes of TSH blood level during a day are not significant; nevertheless, if the results do not correspond with clinical status and other laboratory data, it is recommended to take and test another blood sample. Determination of TSH level in serum is recommended in the following states and conditions: 1. Diagnostics of dysfunction of the thyroid gland; 2. Hypothyroidism (TSH level is increased. The diagnosis is confirmed by low concentrations of total and free T4 and T3. In mild subclinical forms when T4 and T3 levels are within normal ranges, determination of TSH concentration is critical); 3. Hyperthyroidism (synthesis and secretion of TSH are inhibited); monitoring of replacement therapy; 4. Screening for inherited hypothyroidism (on day 5 after birth TSH level in blood is determined). TSH level is elevated just after birth but it comes within the normal range in several days (both in boys and in girls). Serum TSH level is elevated during pregnancy, after physical stress, in individuals with lowered blood pressure and lowered temperature. Secretion of TSH is inhibited by Cortisol and Growth hormone. Low TSH levels are often seen in elderly people, in patients with chronic renal insufficiency, liver cirrhosis, in retardation of sexual development, in secondary amenorrhea, Cushing syndrome, acromegaly. In a present test system, β- chain specific monoclonal antibody XTB32 is used as capture reagent; enzyme-labelled (Fab2)-fragment of another β- chain specific monoclonal antibody XTB2 is used as tracer. This combination enables to minimize both cross-reactive reactions with other pituitary hormones and false positivity caused by anti-species antibodies.

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