Carbohydrate Antigen 199(CA19-9)Test Kit (CLIA), Professional In Vitro Diagnostic Use,CE
A CLIA test kit for quantitative determination of Carbohydrate Antigen 199 (CA19-9) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Carbohydrate Antigen 199(CA19-9)Test Kit (CLIA) is intended for quantitative determination of Carbohydrate Antigen 199 (CA19-9) in human serum and plasma, as an aid in diagnosis of pancreas and other gastrointestinal malignant tumors, and the monitoring of curative effect. For professional in vitro diagnostic use only.
【SUMMARY】
Carbohydrate antigen 19-9 is a tumor marker related to pancreatic cancer, gallbladder cancer, colon cancer and gastric cancer, also known as gastrointestinal related antigen.1 Normally, in the blood of normal people or patients with benign diseases, the carbohydrate antigen 19-9 antigen content is very low. 2, 3 Serum carbohydrate antigen 19-9 has a higher sensitivity and better specificity for pancreatic cancer, and its positive rate is between 85%-95%, and it decreases with the improvement of the condition after surgery.
Therefore, it can be used as an auxiliary diagnostic index for pancreatic cancer, gallbladder cancer and other malignant tumors.4, 5 In patients with gastrointestinal malignancies, especially pancreatic cancer and gallbladder cancer, the level of carbohydrate antigen 19-9 is significantly higher, but the early diagnosis is of little value, and it is mainly used as an indicator of disease monitoring and predicting recurrence. In addition, some non-cancer conditions, such as acute pancreatitis, cholecystitis, hepatitis and non-malignant gastric and intestinal diseases can also lead to increased levels of carbohydrate antigen 19-9.6
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the CA19-9 antibody labeled with alkaline phosphatase, and the magnetic particles coated with the CA19-9 antibody are mixed. After incubation, the CA19-9 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 CA19-9 in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CA19-9 in the sample.
【REAGENTS】
The reagent strip includes CA19-9 antibody coated with magnetic particles, alkaline phosphatase labeled CA19-9 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.
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 Carbohydrate Antigen 199(CA19-9)Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
