A CLIA test kit for the quantitative determination of C-Peptide (CP) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The C-Peptide (CP) Test Kit (CLIA) is intended for quantitative determination of C-Peptide (CP) in human serum and plasma, as an aid in diagnosis of evaluation of islet function.
For professional in vitro diagnostic use only.
【SUMMARY】
C peptide is a single chain polypeptide composed of 31 amino acids. C-peptide is an accompanying product of the cleavage of proinsulin into insulin in the process of insulin biosynthesis. Proinsulin is stored in the secretory granules of the Golgi complex of pancreatic cells and is produced by the cleavage of preproinsulin.
The C peptide plays an important role in the construction of the disulfide bond of the proinsulin molecule and the structure of the insulin double chain (A chain and B chain). Insulin and C-peptide are secreted in equal amounts and released into the peripheral blood circulation.
In this case, the C-peptide value can more accurately reflect the insulin secretion rate in the pancreas than the insulin value. In addition, the C-peptide concentration is not affected by exogenous insulin, and will not be interfered by insulin autoantibodies produced during insulin therapy.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the CP antibody labeled with alkaline phosphatase and the magnetic particles coated with the CP antibody are mixed. After incubation, the CP 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 CP in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CP in the sample.
【REAGENTS】
The reagent strip includes CP antibody coated with magnetic particles, alkaline phosphatase labeled CP 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 C-Peptide (CP) 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 5 days at 2-8 °C.
Features:
Extraordinary Sensitivity
High Accuracy
Good Specificity
Wide Dynamic Range
Extensive Range of Applications
