INTENDED USE
The TSH Rapid Semi-quantitative Test is a chromatoaraphic immunoassay for semi-quantitative determination of Thyroid Stimulating Hormone in serum, plasma and whole blood.
INTRODUCTION
The determination of serum or plasma or whole blood levels of thyroid stimulating hormone (TSH orthyrotropin) is recognized as a sensitive method in the diagnosis of primary and secondary hypothyroidism.TSH is secreted by the anterior lobe of the pituitary gland and induces the production and release ofthyroxine and triiodothyronine from the thyroid gland. lt is a glycoprotein with a molecular weight of approximately 28,000 daltons, consisting of two chemically different subunits, alpha and beta.Although the concentration of TSH in the blood is extremely low, it is essential for the maintenance ofnormal thyroid function. The release of TSH is regulated by a TSH-releasing hormone (TRH) produced by the hypothalamus.The levels of TSH and TRH are inversely related to the level of thyroid hormone. Whenthere is a high level of thyroid hormone in the blood, less TRH is released by the hypothalamus, so less TSHis secreted by the pituitary,. The opposite action will occur when there is decreased thyroid hormone in theblood.This process is known as a negative feedback mechanism and is responsible for maintaining theproper blood levels of these hormonesTSH and the pituitary glycoproteins: luteinizing hormone (LH), follicle-stimulating hormone (FSH), andhuman chorionic gonadotropin (hCG), have identical alpha chains. The beta chains are distinct but docontain regions with identical amino acid sequences, These reaions of homoloay can cause considerablecross-reactivity with some polvclonal TSH antisera, The use of a monoclonal antibody in this TSH aold rapidtest eliminates such cross-reactivity, which could result in falsely elevated TSH values in either menopausalor pregnant females . a population whose evaluation of thyroid status is clinically significant.