Thyroid-stimulating hormone(TSH) ELISA Test Kit
| Section |
Details |
| Intended Use |
The Detection Kit for thyroid-stimulating hormone (TSH) (Enzyme-Linked Immunosorbent Assay, ELISA) is used for quantitative tests of TSH levels in human serum. |
| Summary and Clinical Significance |
TSH Regulation: TSH secretion is regulated by a negative feedback mechanism involving the hypothalamic-pituitary-thyroid axis. Variations in thyroid hormone levels affect TSH production.
Key Factors: <ul><li>Stimulated by thyrotropin-releasing hormone (TRH), a tripeptide from the hypothalamus.</li><li>Inhibited by somatostatin.</li></ul> Normal TSH Range: Below 4.5 mIU/L under baseline conditions in the general population.
Hyperthyroidism: TSH levels are often below 0.1 mIU/L, sometimes at the detection limit.Sensitive TSH assays improve diagnosis of hypothalamic, pituitary, and thyroid disorders. </li></ul> Clinical Implications: Elevated T3 and T4 reduce TSH output.</li><li>A single serum TSH test is not definitive for diagnosing hyperthyroidism, often requiring a dynamic TRH test.High TSH levels typically indicate primary hypothyroidism and necessitate further testing of the pituitary/thyroid axis. Simultaneous elevation of TSH and thyroid hormones may suggest thyroid hormone resistance, requiring dynamic TRH stimulation and T3/T4 inhibition tests. |
| Product details |
Description |
| Delivery |
Within 48 hours |
| Packaging Specifications |
8 x 12 strips, 96 wells |
| Country Of Origin |
China |
| Manufacturer |
18 months |
| Preservation method |
2℃-8℃ |
| Specimen |
Whole blood |
| Assification |
class1 |
| Type |
Elisa Test Kit |
PRINCIPLE
TSH kit uses a “sandwich principle”, Enzyme-linked immunological sorbent assay. To measure TSH levels in serum, plastic wells coated with a monoclonal antibody of TSH are supplied in the kit. After the patient’s specimen and another mono-antibody labelled with HRP are added, TSH, if present, is fixed to the solid phase antibody and creating a HRP-antibody ~TSH~antibody “sandwich”. After TMB substrate added, the result is obtained by EIA plate reader.
MAIN COMPONENTS
Coated Microplate: 1 plate (8×12 wells), Ready to use. Coated with anti-TSH antibody and sealed in an aluminum bag. Remove the strips in the resealable bag with a desiccant to protect from moisture after opened. Store at 2~8℃ until expiration date.
HRP Conjugate: 1 vial of 6ml, Ready to use. Store at 2~8℃ until expiration date.
Calibrator:,7 vials of 1ml, Ready to use. Labeled with S0 to S6 and the concentration of TSH is 0,0.3, 0.6, 1.5, 3.0, 6.0, 12.0mIU/L. Store at 2~8℃ until expiration date.
Control: 2 vials of 1ml, Ready to use. Store at 2~8℃ until expiration date. The concentration of low value is 1.51~2.81 mIU/L. The concentration of high value is 4.8~8.92 mIU/L. Store at 2~8℃ until expiration date.
Chromogen A: 1 vial of 7ml, Ready to use. Store at 2~8℃ until expiration date.
Chromogen B: 1 vial of 7ml, Ready to use. Store at 2~8℃ until expiration date.
Stop Solution: 1 vial of 7ml, Ready to use. Store at 2~8℃ until expiration date.
Wash buffer: 1 vial of 15ml, Concentrate 20-fold, diluting with deionized water before the assay. Store at 2~8℃ until expiration date.
Plate sealer: 2 pieces.
Plastic resealable bag: 1 set.
Instruction manual: 1 copy.
SPECIMEN COLLECTION AND PREPARATION
Serum specimens can be tested by the TSH procedure. Remove serum from the clot as soon as possible to avoid hemolysis. Covered specimens can be stored up to 48 hours at 2~8℃.
Specimens held for a longer time can be frozen at –20℃ and avoid repeated freeze melting.
Serum samples with concentrations expected to be greater than 12 mIU/L should be diluted with normal saline.
NOTE: If needed, remove by centrifugation the suspended fibrin particles or aggregates which are liable to produce falsely positive results.
PREPARATIONS
1.Allow all specimens and reagents to reach room temperature and mix thoroughly by gentle inversion before use.
2.Prepare Wash buffer by diluting Wash Concentrate 20-fold with deionized water. The diluted wash solution is stable in room temperature for at least one week
ATTENTIONS
1. Do not exchange reagents from different lots or use reagents from other commercially available kits. The components of the kit are precisely matched for optimal performance of the tests.
2. Specimens with Hyperlipidemia and icterus show no effects on the detection results. But specimen with severe hemolysis will affect the color of the result, other test methods are suggested to use.
3. Allow the reagents and specimens to reach room temperature before use. Shake reagent gently before use.
4. Concentrated washing liquid will produce crystal at room temperature, should be diluted completely before use.
5. Never reuse microplate sealing membrane.
6. Samples containing anti-sperm antibody, anti-endometrial antibody will not affect the results.
7. Each component of the kit was inactivated, however, it should be regarded as potentially infectious.
PERFORMANCE CHARACTERISTICS
The cut-off value of TSH concentration for healthy subjects is 0.5~5.0 mIU/L.
The detection limit of the assay is approximately 0.15 mIU/L.
- Precision CV＜15%.
- Specificity: No cross reactions with LH, FSH and HCG.
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