A CLIA test kit for the quantitative determination of Cardiac Troponin I (cTnI) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Cardiac Troponin-I (cTnI) Test Kit (CLIA) is intended for quantitative determine of the concentration of Cardiac Troponin I (cTnI) in human whole blood, serum and plasma, as an aid in the diagnosis of myocardial infarction in clinical practice.
For professional in vitro diagnostic use only.
【SUMMARY】
Cardiac troponin I (cTnI) is a contractile protein that exists only in the myocardium. It can form thin filaments with actin and tropomyosin and plays an important role in the process of myocardial contraction . A large number of studies have shown that cTnI levels vary greatly in the early stages of acute myocardial infarction (AMI) with high sensitivity, cTnI is not expressed in any type of skeletal muscle, it has high myocardial tissue specificity.3 Therefore, cTnI is one of the most sensitive and specific serum markers of cardiomyocyte injury. In addition, cTnI has the advantages of clear diagnostic threshold, wide window period and rapid detection. It has gradually become the main biochemical indicator of cardiomyocyte damage in AMI patients.
【PRINCIPLE】
This product adopts the double antibody sandwich method. In the first step, the sample, the cTnI antibody labeled with alkaline phosphatase and the magnetic particles coated with the cTnI antibody are mixed. After incubation, the cTnI 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 the Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of cTnI in the sample. Automatic chemiluminescence immunoassay analyzer can calculate the concentration of cTnI in the sample.
【REAGENTS】
The reagent strip includes cTnI antibody coated with magnetic particles, Alkaline phosphatase labeled with cTnI 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 pecimens. 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 strip 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 Cardiac Troponin-I (cTnI) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
Cardiac Troponin-I (cTnI) is a protein that is released into the bloodstream when the heart muscle is damaged. It is one of the tests used to help diagnose a heart attack and determine how much heart muscle has been damaged.
cTnI tests measure the amount of this protein in the blood. This can be helpful in diagnosing a heart attack as well as seeing how much heart muscle has been damaged. While CK-MB is released into the bloodstream right away when the heart muscle is damaged, cTnI is released more gradually over the course of 8–12 hours after the injury. This makes it a more reliable marker of heart damage.
The cTnI test is usually done along with other tests, such as CK-MB, in people who have signs and symptoms that suggest a heart attack. The test is done by drawing a sample of blood and then measuring the amount of cTnI in it. A high cTnI level usually suggests that the person has experienced a heart attack, although other conditions can lead to elevated cTnI 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.
cTnI levels can take up to a day to rise to their peak after a heart attack, but they can take weeks to return to normal. Consequently, the test is typically repeated within 1–3 days of the initial test to check for any further damage. It can be repeated as often as needed to monitor the person's heart health.
