Place of Origin:
CN
Brand Name:
WWHS
Certification:
CE
Model Number:
T3
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【Product name】
Total Triiodothyronine(TT3)Rapid Quantitative Test(Fluorescence immunoassay)
【Package specification】
25 Tests/kit
【Intended use】
This kit is used for quantitative determination of TT3 in human whole blood, plasma and serum.
Triiodothyronine (T3) hormone is mainly responsible for the symptoms and effects thyroid hormones in different target organs. T3 (3,5,3'- triiodothyronine) is created primarily extrathyroidálně, in the liver, enzyme 5'-dejodací T4. Therefore, the concentration T3 in serum primarily the result of more functional state of peripheral tissues other than the secretory ability of the thyroid gland. Isolating the conversion of T4 to T3 has the effect of reducing the concentration of T3. This effect can be achieved by drugs such as propanolol, glucocorticoids or amiodarone and occurs when nethyroidálních illnesses (NTI), called “Low T3 syndrome”. As for T4, is over 99% of T3 bound to transport proteins. However, the affinity of T3 for them is about 10 times lower.
Determination of TT3 used in the diagnosis of hyperthyroidism, the detection early stages of hyperthyroidism and indications for diagnosis and induced thyrotoxicosis.
【Test principle】
The TT3 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of TT3. The T3 antigen in the sample was first bound with the conjugated compound of fluorescent labeled T3 monoclonal antibody, then moved and combined with another T3 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 T3 monoclonal mouse antibody), nitrocellulose membrane (coated with T3 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.
【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 total triiodothyronine values between 1.23-3.07 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】
【Performance】
1. Limits of detection
No more than 0.50 nmoL/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 (0.50 ~ 10.00nmoL/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.
Note:
1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay
Assay list | ||||||
Thyroid Hormone | ||||||
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 |
16 | TT3 | Serum/Plasma | 15min. | 0.5-10nmol/L | 1.3-3.1nmol/L | thyroid dysfunction |
17 | TT4 | Serum/Plasma | 15min. | 5-300nmol/L | 66-181nmol/L | thyroid dysfunction |
18 | FT3 | Serum/Plasma | 15min. | 1-100pmol/L | 4-10pmol/L | thyroid dysfunction |
19 | FT4 | Serum/Plasma | 15min. | 5-300pmol/L | 19-39pmol/L | thyroid dysfunction |
FAQ
1. What is fluorescent immunoassay analyzer?
The Biopanda Fluorescence Immunoassay Analyser is used by small labs for the detection of a range of biomarkers to assist with the diagnosis and monitoring of several medical conditions including cardiovascular disease, inflammation, kidney disease, thyroid conditions, and fertility.
2. Do you have CE certificate for immunoassay analyzer?
WBC analyzer belongs to IVD other/general, no need CE, Ec declaration is enough.
3. How does fluorescence immunoassay work?
Fluorescent Immunoassays are simply a different type of immunoassay. ... A modern fluorescent based immunoassay uses as the detection reagent a fluorescent compound which absorbs light or energy (excitation energy) at a specific wavelength and then emits light or energy at a different wavelength.
4. What is indirect immunofluorescence assay?
Indirect immunofluorescence, or secondary immunofluorescence, is a technique used in laboratories to detect circulating
autoantibodies in patient serum. It is used to diagnose autoimmune blistering diseases.
5. Is immunofluorescence an immunoassay?
Immunofluorescence assay (IFA) is a standard virologic technique to identify the presence of antibodies by their specific ability to react with viral antigens expressed in infected cells; bound antibodies are visualized by incubation with fluorescently labeled antihuman antibody.
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