Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO13485
Model Number:
TSH
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【Product name】
Thyroid Stimulating Hormone(TSH)Rapid Quantitative Test(Fluorescence immunoassay)
【Package specification】
25 Tests/kit
【Intended use】
This kit is used for quantitative determination of TSH in human whole blood, plasma and serum.
The thyroid stimulating hormone (TSH) is a glycoprotein with a molecular weight of 28000 daltons and secreted from the anterior pituitary and is generally regarded as the most sensitive indicator available for the diagnosis of primary and secondary hypothyroidism. Increase in serum concentration of TSH is primary responsible for the synthesis of thyroxine (T4), and in conjunction with decreased T4 concentration a tool for the diagnosis of primary hypothyroidism. The expected increase in TSH concentrations demonstrates the classical negative feedback system between the pituitary and thyroid glands. Primary thyroid gland failure reduces secretion of the thyroid hormones, which in turn stimulates the release of TSH from the pituitary.
Additionally, TSH measurements are equally useful in differentiating secondary and tertiary 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 (TSH), the thyroid hormones, at the pituitary. Increase levels of TSH 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 and normal. Either pituitary TSH deficiency or insufficiency of stimulation of the pituitary by TRH 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.
【Test principle】
The TSH Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of TSH. The TSH antigen in the sample was first bound with the conjugated compound of fluorescent labeled TSH monoclonal antibody, then moved and combined with another TSH monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
【Components】
Name | Quantity | Component |
Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled TSH monoclonal antibody), nitrocellulose membrane (coated with TSH monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing. |
Sample diluent | 25(200μL/tube) | Phosphate buffer |
ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
【Sample requirements】
【Test procedure】
【Reference interval】
Euthyroid adults are expected to have serum TSH values between 0.3-4.2mIU/L. It is strongly recommended that each laboratory should determine its own normal and abnormal values. The results alone should not be the only reason for any therapeutic consequences. The results should be correlated to other clinical observations and diagnostic tests.
【Interpretation of results】
【Limitations of methods】
【Performance】
1. Limits of detection
No higher than 0.1mIU/L.
2. Accuracy
The relative deviation from the target value is within ±15%.
3. Precision
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (0.1 ~ 100.0mIU/L), the linear correlation coefficient R≥0.990.
【Note】
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃~30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
FAQ:
1. What is the MOQ?
Generally if you choose the different products, our minimum order qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. Does your product have any warranty?
Yes, we offer 6 months limited warranty for our products.
Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.
4. What's your payment method?
We usually accept the payment methods include PayPal, TT, and Western Union.
50% deposit in advance and balance before shipping. Buyer can choose which payment ways that you accept.
PayPal is most useful and safe, please don’t refuse PayPal fee when you choose PayPal.
5. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.
Send your inquiry directly to us