| PRODUCT NAME: |
ST AIA-PACK CA 19-9 |
| INTENDED USE: |
ST AIA-PACK CA 19-9 is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of CA 19-9 in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Carbohydrate Antigen 19-9 (CA 19-9) is a digestive cancer associated antigen. CA 19-9 exists in the blood in the form of a mucinous glycoprotein. CA 19-9 is found in not only tumor tissue, but also in the pancreas, gallbladder, meconium and saliva. The level of serum CA 19-9 is elevated in pancreatic cancer, biliary cancer, colon cancer and liver cancer. Since false positive rate is less for benign diseases, measurement of CA 19-9 is widely used as an effective test for diagnosis of malignant tumors of pancreas and biliary and as an efeective tool to make a decision of medical treatment effectiveness and to do follow-ups. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 25, 50, 100, 200, 420 U/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
1 - 400 U/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK CA 19-9 |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK CA 19-9 CALIBRATOR SET
AIA-PACK CA 19-9 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.