A CLIA test kit for the quantitative determination of Thyroid Stimulating Hormone(TSH)in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
Thyroid Stimulating Hormone(TSH)Test Kit (CLIA), Double Antibody Sandwich Method,0.1-100 MIU/L |
| Principle: |
Double Antibody Sandwich Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-TSH |
| Specimen: |
S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
0.1-100 MIU/L |
【INTENDED USE】
The Thyroid Stimulating Hormone(TSH)Test Kit (CLIA) is intended for quantitative determination of Thyroid Stimulating Hormone(TSH)in human serum and plasma, as an aid in the evaluation of pituitary-thyroid function.
For professional in vitro diagnostic use only.
【SUMMARY】
Thyrotropin (thyroid stimulating hormone, TSH) is a glycoprotein hormone secreted by the anterior pituitary gland. It is composed of two peptide chains, α chain and β chain, containing 211 amino acids, with a relative molecular weight of 25,000 to 28,000 Daltons.1 The role of TSH in promoting thyroid function is :
(1) Promote the synthesis of T4 and T3, promote thyroglobulin synthesis and tyrosine iodination and other links;
(2) promote the release of T4 and T3;
(3) Promote the proliferation, differentiation and growth of thyroid follicular epithelial cells.
The determination of TSH is one of the important indicators for diagnosing thyroid function and studying the hypothalamus-pituitary-thyroid axis. When the hypothalamus and pituitary gland function normally, the measurement of TSH is a sensitive indicator for judging the excess or deficiency of thyroid hormone.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the TSH antibody labeled with alkaline phosphatase, and the magnetic particles coated with the TSH antibody are mixed. After incubation, the TSH in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to 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 TSH in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of TSH in the sample.
【REAGENTS】
The reagent strip includes TSH antibody coated with magnetic particles, Alkaline phosphatase labeled TSH antibody, wash buffer and substrate 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 Thyroid Stimulating Hormone(TSH)Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
【DIRECTIONS FOR USE】
Refer to Automatic Chemiluminescence Immunoassay Analyzer Operation
Manual for the complete instructions on use of the analyzer.
1. Preparation
1) Take the test kit from the refrigerated environment and use it after
equilibrating to room temperature.
2) Dissolution of the Calibrator and Control:Add 500 μL of purified water to each Calibrator/Control for
reconstitution.
Dissolved calibrators /controls are stable for 5 days when stored at 2-8 °C.
3) Input reagent information
Before using a new batch of reagents, the reagent information should be entered.
Run the analyzer software, enter the adding reagent interface and scan the reagent information QR code in the information card to input the test information.
2. Calibration
1) When using a new batch of reagents, calibration must be priority
performed after the reagent information is entered.
2) The system requires double parallel tests for calibrator 1 and calibrator 2 and will assign 2 test slots to calibrator 1 and calibrator 2 respectively by default and the four tests should be done in one time.
Follow calibration procedures according to the user manual of the analyzer.
Load the reagent strips, then add 100-150 μL of corresponding dissolved calibrator 1 and 2 to the corresponding sample well of the reagent strips, finally tap the start button to perform the calibration tests.
3) Calibration frequency:
Once a calibration is accepted and stored, all subsequent samples may be
tested without further calibration unless:
A reagent kit with a new lot number is used.
Reagents of the same batch number have been used for more than 4 weeks.
As required: For example, controls testing are out of range.
1) Input Quality control information
Input the QC information into the system by scanning the QR code of the quality control in the information card provided with the kit.
2) Follow control procedures according to the user manual of the analyzer.
3) Load the reagent strips and add 100-150 μL of corresponding dissolved control materials, then tap the start button to perform the control tests. The recommended control requirement for the TSH test is a single test of all control levels tested once every 24 hours in daily use. If the quality control procedures in your laboratory require more frequent use of controls to verify test results, follow your laboratory-specific procedures. Make sure the control values are within the defined ranges.
Each laboratory should establish corrective measures to be taken if control values fall outside the defined limits.
4. Sample test
Sample test can be performed on condition that the test results of calibration and quality control meet the requirements. (Calibration results indicate successful and Control results fall within the specified ranges in the information card.)
Tap [Analy] and select [TSH] item.
Follow sample test procedures according to the user manual of the analyzer.
Load the reagent strips and add 100-150 μL of sample to the sample well, and tap Start button. After the detection is finished, the concentration will be calculated by the software and displayed on the screen.
【INTERPRETATION OF RESULTS】
The TSH test result should be calculated by Automatic Chemiluminescence Immunoassay Analyzer and displayed on the screen. For additional information, please refer to the user manual of Automatic Chemiluminescence Immunoassay Analyzer.
