A CLIA test kit for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Carcinoembryonic Antigen(CEA)Test Kit (CLIA) is intended for quantitative determination of CEA in human serum and plasma. Mainly used for observation of curative effect of malignant tumors, prognosis judgment and recurrence monitoring, etc.
For professional in vitro diagnostic use only.
【SUMMARY】
CEA is a monomeric glycoprotein, a group of fetal cancer antigens produced in the embryonic stage. The determination of serum CEA is of great significance for patients with malignant diseases, especially for the prognosis and management of patients with colorectal cancer.
Continuous measurement can monitor the progress, regression or recurrence of cancer in treated patients. After treatment or surgical intervention signals, the CEA level continues to increase, which means residual disease or disease recurrence, and if the level is reduced and within the normal range, it means the intervention is successful.
Serum CEA levels in patients with non-malignant diseases and heavy smokers may also increase , CEA testing is not used to diagnose cancer, but it may assist doctors in predicting how a person’s cancer likely to develop, determining treatment effectiveness, and assessing whether or not cancer has returned after treatment.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the CEA antibody labeled with alkaline phosphatase, and the magnetic particles coated with the CEA antibody are mixed. After incubation, the CEA 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 CEA in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CEA in the sample.
【REAGENTS】
The reagent strip includes CEA antibody coated with magnetic particles, alkaline phosphatase labeled CEA 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 Carcinoembryonic Antigen(CEA)Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
【EXPECTED RESULTS】
Due to the non-parametric method, this reagent performs a 90% median analysis on the CEA test results of 242 normal population samples with a 95% confidence level, and the 95% percentile concentration value is less than 5.00 ng/mL.
Due to differences in geography, race, gender, and age, it is recommended
that each laboratory establish its own reference value (range).
