PRODUCT NAME: |
ST AIA-PACK CEA |
INTENDED USE: |
ST AIA-PACK CEA is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of carcinoembryonic antigen (CEA) in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
SUMMARY AND EXPLANATION OF TEST: |
Carcinoembryonic antigen (CEA), is normally present at very low concentration in the blood of healthy adults. The level of serum CEA is elevated in many gastrointestinal cancers, such as, colon cancer, pancreatic cancer and gastric cancer, and there have been some positive cases of lung cancer, uterine cancer, ovarian cancer and embryonic carcinoma. Since the positive rate is low in benign diseases, CEA assay is widely used as an effective clinical test for diagnosing, assessing therapeutic effects and monitoring these malignancies. Preoperative CEA levels may be of prognostic value since the level of elevation is correlated with body burden of tumor. |
TECHNICAL SPECIFICATIONS: |
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Method: |
Enzyme Immunoassay (EIA) |
Principle: |
Two-site immunoenzymometric assay |
Calibrators: |
0, 50 ng/mL |
Assay sample: |
Serum and heparinized plasma |
Assay range: |
0.5 - 100 ng/mL |
Reaction time: |
10 minutes |
Storage: |
2 - 8 ºC |
Kit Contents: |
ST AIA-PACK CEA |
Consumables: |
AIA-PACK SUBSTRATE SET II AIA-PACK CEA CALIBRATOR SET AIA-PACK CEA SAMPLE DILUTING SOLUTION AIA-PACK WASH CONCENTRATE AIA-PACK DILUENT CONCENTRATE AIA-PACK DETECTOR STANDARDIZATION TEST CUP AIA-PACK SAMPLE TREATMENT CUP SAMPLE CUPS |
*Please refer to the product Instruction-For-Use (IFU) for complete details.