A CLIA test kit for the quantitative determination of Triiodothyronine (T3) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Triiodothyronine (T3) Test Kit (CLIA) is intended for quantitative determination of Triiodothyronine (T3) in human serum and plasma.as an aid in the evaluation of thyroid function.
For professional in vitro diagnostic use only.
【SUMMARY】
The concentration of thyroid hormone and the degree of its biological effects are controlled by the hypothalamus-pituitary-thyroid axis. T3 is a hormone synthesized and secreted by thyroid follicular cells. It is one of the main thyroid hormones. Symptoms and effects in different target organs. In individuals with normal thyroid function, only a small proportion (20%) of
the total T3 concentration in the serum is directly secreted by the thyroid, and the remaining part of the total T3 is derived from the deiodination of T4 to T3 enzymes in peripheral tissues.1 The concentration of T3 in serum can be changed by changes in thyroid activity or changes in T4 peripheral metabolism.
The thyroid is controlled by thyroid stimulating hormone, and thyroid stimulating hormone is regulated by hypothalamic thyroid
stimulating hormone releasing hormone. T3 has negative feedback control on the release of thyroid stimulating hormone. T3 levels higher than normal will block the release of thyroid stimulating hormone.
The determination of serum T3 is the most useful for the diagnosis of thyroid dysfunction. In most patients with this disease, both T3 and T4 are elevated. In some cases, hyperthyroidism is only caused by elevated T3 concentration, which is called “T3 thyrotoxicosis”. The low concentration of T3 is caused by primary hypothyroidism, severe hypothyroidism, thyroiditis and neonatal hypothyroidism, or secondary hypothyroidism caused by the lack of hypothalamus-pituitary level.
【PRINCIPLE】
This product uses the competition method. In the first step, incubate the sample with the pretreatment solution to release T3 from the binding protein.
The second step is to mix the processed sample with magnetic particles coated with T3 antibody. After incubation, magnetic separation and cleaning, the T3 in the sample binds to the antibody on the magnetic particles and is fixed on the magnetic particles. In the third step, add T3 labeled with alkaline phosphatase and incubate. Finally, magnetic separation and cleaning are performed to remove free enzyme-labeled T3.
Add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of T3 in the sample.
Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of T3 in the sample.
【REAGENTS】
The reagent strip includes T3 antibody coated with magnetic particles, alkaline phosphatase labeled T3, wash buffer and substrate solution, pretreatment solution.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Read the entire package insert carefully prior to testing.
3. Do not use after the expiration date indicated on the package.
4. The single reagent strip has been assembled into a ready-to-use unit that cannot be separated.
5. Do not interchange or mix reagents from different batches.
6. Used test materials should be disposed of in accordance with local regulations.
7. Test kits and samples need to be equilibrated to room temperature before testing.
8. It is recommended to use fresh blood. Samples with high-fat chylo, jaundice, and high rheumatoid factor are not recommended and hemolyzed samples are also not recommended.
9. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
10. The test results of this kit are for clinical reference only, clinical diagnosis and treatment of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests and treatment responses.
11. Due to methodological or antibody specificity and other reasons, test the same sample with reagent strips from different manufacturers may result in different test results. The results obtained from testing with different reagent strips should not be directly compared with each other, which may cause erroneous medical interpretations.
12. Store and test reasonably in strict accordance with the instructions of the package insert. Keep the reagents away from light, do not turn it over.
13. The Triiodothyronine (T3) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
【STORAGE AND STABILITY】
1. Unopened test kits should be stored at 2-8 °C. When stored and handled as required, all unopened reagents are stable through the expiration date printed on the label.
2. Do not freeze. Do not turn the reagent strips over.
3. Store the test kit upright. Do not expose reagents to strong light during storage. Care should be taken to protect the components of the test from contamination.
4. Remaining reagents in the kit should be stored at 2-8°C immediately.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment,
containers or reagents may lead to false results.
6. Calibrator and Control Materials:
Unopened:
Stable until the expiration date when stored at 2-8 °C.
Opened:
Undissolved: Stable for 1 week at 2-8 °C, avoid deliquescence
Dissolved: Stable for 2 days at 2-8 °C
