ThyroxineIndex (T4) Test Kit (CLIA),Chemiluminescence Immunoassay Test,Competition Method
A CLIA test kit for the quantitative determination of ThyroxineIndex (T4) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
ThyroxineIndex (T4) Test Kit (CLIA),Chemiluminescence Immunoassay Test,Competition Method |
| Principle: |
Competition Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-T4 |
| Specimen: |
S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
10-300 Ng/mL |
【INTENDED USE】
The ThyroxineIndex (T4) Test Kit (CLIA) is intended for quantitative determination of ThyroxineIndex (T4) in human serum and plasma, as an aid in the evaluation of thyroid function.
For professional in vitro diagnostic use only
【SUMMARY】
Thyroid hormones are two hormones produced and released by the thyroid gland, namely triiodothyronine (T3) and thyroxine (T4). They are tyrosine-based hormones that are primarily responsible for regulation of metabolism. The major form of thyroid hormone in the blood is thyroxine (T4), which has a longer half-life than T3.
The hypothalamus-pituitary-thyroid axis controls the synthesis, release and production of thyroid hormones. The hypothalamus secretes thyroid-stimulating hormone-releasing hormone (TRH), which stimulates the synthesis and release of thyroxine or thyroid-stimulating hormone (TSH). TSH in turn stimulates the synthesis, storage, secretion and metabolism of thyroxine (T4) and triiodothyronine (T3).
The basic characteristics of thyroid hormone production and storage include: iodine absorption; tyrosine residue iodine contained in thyroglobulin molecule; monoiodotyrosine (MIT) and diiodotyrosine (DIT) combine to form T4 and T3 ; Thyroid storage forms thyroglobulin; and releases thyroid hormones into the blood circulation. Most of T4 and T3 bind to the carrier protein as soon as they enter the blood circulation. These two hormones have the greatest affinity for thyroxine-binding globulin (TBG) and, to a lesser extent, thyroxine-binding prealbumin (TBPA).
Therefore, only a small amount of free phase remains in the combined phase of 99.97% of the T4 blood circulation and 99.7% of the T3 blood circulation.T4 and T3 regulate normal growth and development. They can be used to maintain body temperature, stimulate caloric production and affect the metabolism of various carbohydrates, as well as a small amount of lipid and vitamin metabolism. The development of fetuses and newborns also requires thyroid hormones.
Thyroxine is usually measured as total thyroid T4 in human serum, including bound and free T4. It can be used for thyroid screening alone or in combination with other thyroid tests. The measurement of total T4 without abnormal binding capacity can reliably reflect the clinical thyroid condition. When the binding protein is changed, it will affect the total thyroid T4 level, but the free hormone level is unchanged.
【PRINCIPLE】
This product uses the competition method. In the first step, incubate the sample with the pretreatment solution to release T4 from the binding protein. The second step is to mix the processed sample with magnetic particles coated withT4 antibody. After incubation, magnetic separation and cleaning.the T4 in the sample binds to the antibody on the magnetic particles and is fixed on the magnetic particles.
In the third step, add T4 labeled with alkaline phosphatase and incubate. Finally, magnetic separation and cleaning are performed to remove free enzyme-labeled T4. 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 T4 in the sample.
Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of T4 in the sample.
【REAGENTS】
The reagent strip includes T4 antibody coated with magnetic particles, alkaline phosphatase labeled T4, 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 ThyroxineIndex (T4) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
