Serum Thyroid-Stimulating 96Hormone Tsh Elisa Reagent Kits For 96 people
Intended use
Immunoassay for the in vitro quantitative determination of thyrotropin in human
serum.
Summary
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)
| PRODUCT DETIAL |
DESCRIPTION |
| Testing principle |
Immunoassay
|
| Specimen |
Serum |
| Kit Size |
96 tests/box |
| Manufacturer |
BIOVANTION |
| Shelf Life |
18 months |
| Storage Temperature |
2-8℃ |
| Safety Standard |
Class I |
| Accuracy |
±0.1% |
Features of TSH Elisa Kit:
1. Quantitation detection
2.High sensitivity
3.Clear dividing line
4. Easy to use
5. Hhigh specificity
Reagents 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
Precision
Precision was determined using reagents, pooled human sera, and controls in a modifified protocol (EP5-A) of the CLSI (Clinical and Laboratory Standards Institute): 2 times daily for 20 days (n = 40). The following results were obtained
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