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REF: DS177701 96 tests 

Intended use
Immunoassay for the in vitro quantitative determination of thyrotropin in human serum.

Thyroid-stimulating hormone (TSH, thyrotropin) is a glycoprotein having a molecular weight of approx. 30000 daltons and consisting of two subunits. Measurement of the serum concentration oftentimes thyrotropin (TSH), a glycoprotein with a molecular weight of 28,000 daltons and secreted from the anterior pituitary, is generally regarded as the most sensitive indicator available for the diagnosis of primary and secondary (pituitary) hypothyroidism (1,2).
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.Further, the advent of immunoenzymometric assays has provided the laboratory with sufficient sensitivity to enable the differentiating of hyperthyroidism from euthyroid population and extending the usefulness of TSH measurements. This method is a second-generation assay, which provide the means for discrimination in the hyperthyroid-euthyroid range. (3)

Materials provided

• Coated Microplate, 8 x 12 strips, 96 wells, pre-coated with mouse monoclonal Anti-TSH.
• Calibrators, 6 vials, 1 ml each, ready to use; Concentrations: 0(A), 0.5(B), 2(C), 5(D), 10(E) and 25(F) μIU/mL.
• Enzyme Conjugate, 1 vial, 6.0 ml of HRP (horseradish peroxidase) labeled mouse monoclonal Anti-TSH in Tris-NaCl buffer containing BSA (bovine serum albumin). Contains 0.1% ProClin300 preservative.
• Substrate, 1 vial, 11ml, ready to use, (tetramethylbenzidine) TMB.
• Stop Solution, 1 vial, 6.0 ml of 1 mol/l sulfuric acid.
• Wash Solution Concentrate, 1 vial, 25 ml (40X concentrated), PBS-Tween wash solution.
• IFU, 1 copy.
• Plate Lid: 1 piece.

Materials required (but not provided)
• Microplate reader with 450nm and 620nm wavelength absorbent capability.
• Microplate washer. 
• Incubator.
• Plate shaker.
• Micropipettes and multichannel micropipettes delivering 50μl with a precision of better than 1.5%.
• Absorbent paper.
• Distilled water