A CLIA test kit for the quantitative determination of Creatine Kinase MB (CKMB) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
Creatine Kinase MB (CKMB) Test Kit (CLIA), Automatic Chemiluminescence Immunoassay |
| Principle: |
Double Antibody Sandwich Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-CKMB |
| Specimen: |
WB/S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
2-500 Ng/mL |
【INTENDED USE】
The Creatine Kinase MB (CKMB) Test Kit (CLIA) is intended for quantitative determination of Creatine Kinase MB (CKMB) in human whole blood, serum and plasma, as an aid in the diagnosis of myocardial infarction, myopathy and other diseases.
For professional in vitro diagnostic use only.
【SUMMARY】
Creatine kinase (CK) is a dimeric enzyme which occurs in 4 different forms: a mitochondrial isoenzyme and the cytosolic isoenzymes CK-MM (muscle type), CK-BB (brain type) and CK-MB (muscle-brain type). CK‑MB is an important biomarker of acute myocardial infarction and other causes of myocardial injury, such as heart failure and myocarditis. CK-MB can be detected in the blood about 3-8 hours after the onset of cardiacsymptoms and can be detected continuously over a long period of time, depending on the course of the condition. CK‑MB may also appear in other clinical conditions, e.g. rhabdomyolysis and stroke.
【PRINCIPLE】
This product adopts double antibody sandwich method. In the first step, the sample, the CKMB antibody labeled with alkaline phosphatase and the magnetic particles coated with the CKMB antibody are mixed. After incubation, the CKMB 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 CKMB in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CKMB in the sample.
【REAGENTS】
The reagent strip includes CKMB antibody coated with magnetic particles, alkaline phosphatase labeled CKMB 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 test 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 reagents from different manufacturers may result in different test results. The results obtained from testing with different reagents 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 Creatine Kinase MB (CKMB) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by medical professionals.
Creatine Kinase MB (CK-MB) is an enzyme found mainly in heart muscle cells. It is released into the bloodstream after a heart attack, when heart muscle cells are damaged. CK-MB tests measure the amount of this enzyme in the blood, which can help doctors diagnose a heart attack and determine how much heart muscle has been damaged.
CK-MB is an enzyme, or protein, that is located inside heart muscle cells. Under normal circumstances, it is not found in the bloodstream. But when the heart muscle is damaged, CK-MB is released into the bloodstream. The amount of CK-MB in the blood reflects how much heart muscle has been damaged.
The CK-MB test is typically done in people who have chest pain or other signs and symptoms that suggest a heart attack. It's usually done along with other tests such as troponin, which also measure substances released into the bloodstream after a heart attack.
The CK-MB test is done by drawing a sample of blood and then measuring the amount of CK-MB in it. A high level of CK-MB usually suggests that the person has experienced a heart attack, although other conditions can lead to elevated CK-MB levels, too. The results of this test, along with those of other tests, can help doctors determine the cause of chest pain and the best way to treat it.
CK-MB levels normally return to normal within 24–48 hours after a heart attack, so the test is usually repeated at that point to check for any further damage. It can be repeated as often as needed to monitor the person's heart health.
