Cancer Antigen 125 (CA125) Test Kit (CLIA),2.3-1000 U/mL Double Antibody Sandwich Method
Cat No.:
CI-CA125
Principle:
Double Antibody Sandwich Method
Specimen:
S/P
Pack:
40T
Shelf Life:
2 Years
Format:
Strip
Certificate:
CE
Storage Temperature:
2-8℃
Cut-Off:
2.3-1000 U/mL
Packaging Details:
40T
Supply Ability:
10 M tests/month
Highlight:
1000 U/mL CLIA Test
,
Cancer Antigen 125 CLIA Test
,
Double Antibody Sandwich Method CLIA Test
Product Description
Cancer Antigen 125 (CA125) Test Kit (CLIA),2.3-1000 U/mL Double Antibody Sandwich Method
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.
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 AutomaticChemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Cancer Antigen 125 (CA125) Test Kit (CLIA) is intended forquantitative determination of Cancer Antigen 125 (CA125) in human serumand plasma, as an aid in diagnosis and treatment monitoring of ovariancancer and other diseases.
For professional in vitro diagnostic use only.
【SUMMARY】
CA125 is a glycoprotein detected from epithelial ovarian cancer antigenthat can be bound by monoclonal antibody OC125, with a molecular weightof about 200~1000KD. It is derived from the body cavity epitheliumduring embryonic development and does not exist in normal ovarian tissue.
Therefore, it is most commonly found in the serum of patients withepithelial ovarian tumors (serous tumors). The diagnosis is highly sensitivebut 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 thedisease, 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 ofother malignant tumors such as fallopian tube adenocarcinoma,endometrial cancer, cervical cancer, pancreatic cancer and bowel cancerwill increase.
In addition, CA125 can also be found in a variety of gynecological benigndiseases, such as ovarian cysts, endometrial diseases, cervicitis anduterine fibroids. Other benign diseases, such as acute and chronicpancreatitis, gastrointestinal diseases, renal failure, autoimmune diseases,etc. CA125 will also be higher than normal. Obviously increase can also beseen 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, andthe magnetic particles coated with the CA125 antibody are mixed. Afterincubation, the CA125 in the sample forms an immune complex with thecorresponding antibody. In the second step, magnetic separation andcleaning are performed to remove free enzyme-labeled antibodies. Thethird step is to add the chemiluminescent substrate solution to the immunecomplex.
Luminescence signal generated by the enzyme reaction isdetected by Automatic Chemiluminescence Immunoassay Analyzer andthe detected luminescence intensity is related to the concentration ofCA125 in the sample. Automatic Chemiluminescence ImmunoassayAnalyzer 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 substratesolution.
【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 unitthat cannot be separated.
5. Do not interchange or mix reagents from different batches.
6. Used test materials should be disposed of in accordance with localregulations.
7. Test kits and samples need to be equilibrated to room temperaturebefore testing.
8. It is recommended to use fresh blood. Samples with high-fat chylo,jaundice, and high rheumatoid factor are not recommended andhemolyzed samples are also not recommended.
9. Handle all specimens as if they contain infectious agents. Observeestablished precautions against microbiological hazards throughout allprocedures and follow the standard procedures for proper disposal ofspecimens. 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, clinicaldiagnosis and treatment of patients should be comprehensivelyconsidered in conjunction with their symptoms/signs, medical history,other laboratory tests and treatment responses.
11.Due to methodological or antibody specificity and other reasons, testthe same sample with reagent strips from different manufacturers mayresult in different test results. The results obtained from testing withdifferent 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 ofthe package insert. Keep the reagents away from light, do not turn itover.
13.The Cancer Antigen 125 (CA125) Test Kit (CLIA) should only be usedwith the Automatic Chemiluminescence Immunoassay Analyzer byprofessionals
