A CLIA test kit for the quantitative determination of Cytokeratin-19-fragment (CYFRA21-1) in human serum or plasma with the
use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Cytokeratin-19-fragment (CYFRA21-1) Test Kit (CLIA) is intended for quantitative determination of Cytokeratin-19-fragment (CYFRA21-1) in human serum and plasma, mainly used for the observation of curative effect of non-small cell lung cancer, recurrence monitoring, etc. For professional in vitro diagnostic use only.
【SUMMARY】
Cytokeratin-19-fragment CYFRA21-1 is a member of the keratin polypeptide family. When alveolar epithelial cells undergo apoptosis, the keratin fragments contained in the cells degrade into soluble substances and enter the bloodstream to increase the blood content of CYFRA21-1.1, 2 It is the first-choice marker for non-small cell lung cancer. In particular, the tumor markers of choice for squamous cell carcinoma have a sensitivity of up to 60% and a specificity of up to 95%.3.4 In addition, other cancers, such as bladder cancer, also have increased levels of cytokeratin 19 fragments.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the CYFRA21-1 antibody labeled with alkaline phosphatase, and the magnetic particles coated with the CYFRA21-1 antibody are mixed.
After incubation, the CYFRA21-1 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 CYFRA21-1 in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CYFRA21-1 in the sample.
【REAGENTS】
The reagent strip includes CYFRA21-1 antibody coated with magnetic particles, alkaline phosphatase labeled CYFRA21-1 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 Cytokeratin-19-fragment (CYFRA21-1) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
The CYFRA21-1 test result should be calculated by Automatic
Chemiluminescence Immunoassay Analyzer and displayed on the screen.
For additional information, please refer to the user manual of Automatic
Chemiluminescence Immunoassay Analyzer.
【LIMITATIONS】
1. For professional in vitro diagnostic use only.
2. Unreasonable sample collection, storage and processing procedures may lead to erroneous test results.
3. Test results beyond the detection range of the kit are not credible.
4. Severe hemolysis, incomplete agglutination or microbial contamination may cause errors in the results.
【EXPECTED RESULTS】
Due to the non-parametric method, this reagent performs a 90% median analysis on the CYFRA21-1 test results of 200 normal population samples with a 95% confidence level, and the 95% percentile concentration value is less than 3.3 ng/mL.
Due to differences in geography, race, gender, and age, it is recommended
that each laboratory establish its own reference value (range).
