Description
Product Specifications
COA
IFU
Instrument
Description
Human Thyroid Stimulating Hormone (TSH) or thyrotropin is a glycoprotein with a molecular weight of approximately 28,000 daltons, synthesized by the basophilic cells (thyrotropes) of the anterior pituitary. TSH measurements are equally useful in differentiating secondary and tertiary (hypothalamic) hypothyroidism from the primary thyroid disease. TSH release from the pituitary is regulated by thyrotropin releasing factor (TRH), which is secreted by the hypothalamus, and by direct action of T4 and triiodothyronine (T3), the thyroid hormones, at the pituitary. Increase levels of T3 and T4 reduces the response of the pituitary to the stimulatory effects of TRH. In secondary and tertiary hypothyroidism, concentrations of T4 are usually low and TSH levels are generally low or normal. Either pituitary TSH deficiency (secondary hypothyroidism) or insufficiency of stimulation of the pituitary by TRH (tertiary hypothyroidism) causes this. The TRH stimulation test differentiates these conditions. In secondary hypothyroidism, TSH response to TRH is blunted while a normal or delayed response is obtained in tertiary hypothyroidism.
Product Specifications
Intended Use
Thyroid Stimulating Hormone Assay Kit is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Thyroid Stimulating Hormone (TSH) in human serum and plasma. The assay kit is intended for in vitro diagnostic use.
Principle
The Thyroid Stimulating Hormone assay is a quantitative sandwich immunoassay to determine the presence of TSH in human serum and plasma using CMIA technology with flexible assay protocols.
- Sample, and paramagnetic anti-TSH coated microparticles are mixed, TSH present in the sample binds to anti-TSH coated microparticles, forming an antigen antibody complex.
- After incubation, a conjugate containing acridinium-labeled anti-TSH is added to the reaction mixture and binds to unoccupied binding sites of the anti-TSH coated microparticles.
- After further incubation and washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture.
- The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a relationship between the amount of TSH in the sample and the RLUs detected by the Optical system. Results are calculated automatically based on the previously established calibration curve.
Storage
The kit should be stored upright, not upside down or horizontally. Store at 2–8°C with a validity period of 12 months.
COA
IFU
Instrument