|Place of Origin:||CN|
|Certification:||ISO 13485, CE|
|Minimum Order Quantity:||1000|
|Price:||US 1.50-2.99 Kit|
|Packaging Details:||Colorful Paper Box|
|Delivery Time:||10 Days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||40000 Kits per Week|
|Product Name:||T4 Rapid Quantitative Test Kit||Sample Buffer:||25 Vials|
|Warranty:||12 Months||Applicable Instruments:||NIR-1000 Dry Fluorescent Immunoassay Analyzer|
|Storage:||4-30℃||Formal Name:||Thyroxine Rapid Test|
|Accurate:||High Sensitivity And Specifity||Format:||Cassette|
800 Tests/hour Thyroid Hormone T3 T4,
CE Thyroid Hormone T3 T4,
T4 Fluorescence Immunoassay Test Cassette
Total Thyroxine(TT4)Rapid Quantitative Test(Fluorescence immunoassay)
This kit is used for quantitative determination of TT4 in human whole blood, plasma and serum.
The hormone thyroxine (T4) is the main product secreted by the thyroid gland and incorporated into the regulatory system in the axis hypothalamus-pituitary-thyroid gland. The metabolism of the anabolic effects. Thyroxine is produced in the coupling reaction two molecules of 3,5-dijodthyrosinu in the thyroid gland. Is stored in bound form on thyroglobulin in thyroid follicle lumens and is secreted under the influence of TSH. A substantial proportion (> 99%) of total thyroxine (T4) in serum is bound to proteins. The concentration of transport proteins in serum is subject to endogenous and exogenous factors, and therefore the status of these binding proteins should be taken into account when assessing levels of thyroid hormones in serum. Apart from the that changes in protein binding (eg, under the influence of estrogen on pregnancy, nephrotic syndrome, etc.) may be such that metabolic status of thyroid gland evaluate incorrectly.
Determination of TT4 may have the following indications: Evaluation of hyperthyroidism, Primary and secondary hypothyroidism and TSH suppression therapy monitoring.
The TT4 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of TT4. The T4 antigen in the sample was first bound with the conjugated compound of fluorescent labeled T4 monoclonal antibody, then moved and combined with another T4 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.
|Test cards||25||It is composed of fluorescent pad (coated with fluorescent labeled T4 monoclonal mouse antibody), nitrocellulose membrane (coated with T4 monoclonal mouse 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.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Euthyroid adults are expected to have serum total thyroxine values between 66.0-181.0 nmoL/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】
1. Limits of detection
No higher than 5.0nmoL/L.
The relative deviation from the target value is within ±15%.
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (5.0 ~300.0 nmoL/L), the linear correlation coefficient R≥0.990.
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.
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|15||TSH||Serum/Plasma||15min.||0.3-100mU/L||0.35-5mU/L||hyperthyroidism and hypothyroidism|
Interpretation of results
1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
WWHS NIR-1000 dry fluoroimmunoassay analyser
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Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen