A CLIA test kit for the quantitative determination of Ferritin in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Ferritin Test Kit (CLIA) is intended for quantitative determination of Ferritin in human whole blood, serum and plasma. Determination of serum ferritin is an important indicator for judging the iron storage in the body. It is of great significance in the diagnosis of iron deficiency anemia, iron overload and nutritional status surveys. As a tumor marker, ferritin also has certain reference value for the diagnosis of certain malignant tumors in clinic.
For professional in vitro diagnostic use only.
【SUMMARY】
Ferritin is a large globular protein with a molecular weight of approximately 45,000 Daltons and is composed of 24 subunits. These subunits form a shell around the center, which contains an unlimited amount of hydroxy iron phosphate. A ferritin molecule can bind 4000-5000 iron atoms. It has been proved that in the case of complete saturation, the ferritin molecule can contain more than 20% by weight of iron.
Serum ferritin level is a common diagnostic tool for assessing iron status. Elevated ferritin is common in acute leukemia, Hodgkin's disease, lung cancer, colon cancer, colon cancer, liver cancer and prostate cancer. Ferritin detection can be used as an indicator of liver metastatic disease.
Studies have shown that 76% of patients with liver metastatic disease have ferritin levels higher than 400 ng/mL. The increase in ferritin content may be caused by factors such as cell necrosis, obstruction of red blood cell synthesis and increased synthesis of tumor tissue.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the Ferritin antibody labeled with alkaline phosphatase, and the magnetic particles coated with the Ferritin antibody are mixed. After incubation, the Ferritin 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 Ferritin in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of Ferritin in the sample.
【REAGENTS】
The reagent strip includes Ferritin antibody coated with magnetic particles, alkaline phosphatase labeled Ferritin 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 iagnosis 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 Ferritin 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:
Stable for 1 week at 2-8 °C
