Squamous Cell Carcinoma Antigen(SCC)Test Kit (CLIA), Double Antibody Sandwich Method, 0.5-70 Ng/ML
A CLIA test kit for the quantitative determination of Squamous Cell Carcinoma Antigen(SCC)in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
Squamous Cell Carcinoma Antigen(SCC) Test Kit (CLIA), Double Antibody Sandwich Method, 0.5-70 Ng/mL |
| Principle: |
Double Antibody Sandwich Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-SCC |
| Specimen: |
S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
0.5-70 Ng/mL |
【INTENDED USE】
The Squamous Cell Carcinoma Antigen(SCC)Test Kit (CLIA) is intended for quantitative determination of Squamous Cell Carcinoma Antigen(SCC) in human serum and plasma, as an aid in diagnosis of cervical cancer, non-small cell carcinoma, etc. For professional in vitro diagnostic use only.
【SUMMARY】
Squamous cell carcinoma antigen (SCC Ag) was first isolated from cervical squamous cell carcinoma tissue in 1977, also known as TA-4 antigen.
SCC-Ag is a group of tumor associated proteins, which is closely related to the occurrence and development of squamous cell carcinoma.1-3 SCC-Ag is associated with the invasion, metastasis, recurrence and prognosis of squamous cell, it is an important tumor marker reflecting the biological characteristics of squamous cell carcinoma.4 Its serum level detection is widely used in the diagnosis of multiple organ squamous cell carcinoma and the clinical evaluation of therapeutic effect. Serum SCC can be used to detect squamous epithelial tumors, including cervix, esophagus, head and neck, lung, rectum, skin and so on. The most important application of SCC in lung cancer is assisted histology diagnosis. Elevated serum SCC level strongly indicates the presence of NSCLC, especially squamous cell lung cancer.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the SCC antibody labeled with alkaline phosphatase, and the magnetic particles coated with the SCC antibody are mixed. After incubation, the SCC 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 hird 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 SCC in the sample. Automatic Chemiluminescence Immunoassay Analyzer can
calculate the concentration of SCC in the sample.
【REAGENTS】
The reagent strip includes SCC antibody coated with magnetic particles, alkaline phosphatase labeled SCC 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 Squamous Cell Carcinoma Antigen(SCC)Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
