Features:
Extraordinary Sensitivity
High Accuracy
Good Specificity
Wide Dynamic Range
Extensive Range of Applications
A CLIA test kit for the quantitative determination of Cancer Antigen 125 (CA125) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Cancer Antigen 125 (CA125) Test Kit (CLIA) is intended for quantitative determination of Cancer Antigen 125 (CA125) in human serum and plasma, as an aid in diagnosis and treatment monitoring of ovarian cancer and other diseases.
For professional in vitro diagnostic use only.
【SUMMARY】
CA125 is a glycoprotein detected from epithelial ovarian cancer antigen that can be bound by monoclonal antibody OC125, with a molecular weight of about 200~1000KD. It is derived from the body cavity epithelium during embryonic development and does not exist in normal ovarian tissue.
Therefore, it is most commonly found in the serum of patients with epithelial ovarian tumors (serous tumors). The diagnosis is highly sensitive but poor specificity.not present in mucinous ovarian tumors. Therefore, it is not used alone for the early diagnosis of epithelial ovarian cancer.
Serum CA125 in 90% of patients is related to the progression of the disease, so it is mostly used for disease detection and efficacy evaluation. CA125 is not only a specific marker of ovarian cancer, but also the levels of other malignant tumors such as fallopian tube adenocarcinoma, endometrial cancer, cervical cancer, pancreatic cancer and bowel cancer will increase.
In addition, CA125 can also be found in a variety of gynecological benign diseases, such as ovarian cysts, endometrial diseases, cervicitis and uterine fibroids. Other benign diseases, such as acute and chronic pancreatitis, gastrointestinal diseases, renal failure, autoimmune diseases, etc. CA125 will also be higher than normal. Obviously increase can also be seen in liver cirrhosis and hepatitis.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the CA125 antibody labeled with alkaline phosphatase, and the magnetic particles coated with the CA125 antibody are mixed. After incubation, the CA125 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 CA125 in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of CA125 in the sample.
【REAGENTS】
The reagent strip includes CA125 antibody coated with magnetic particles, alkaline phosphatase labeled CA125 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 Cancer Antigen 125 (CA125) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals
