| PRODUCT NAME: |
ST AIA-PACK CA 125 |
| INTENDED USE: |
ST AIA-PACK CA 125 is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of CA 125 in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
CA 125 is a glycoprotein, an antigen that plays an important role of tumor marker or biomarker. Elevated serum levels of CA 125 are associated with greater than 80% of nonmucinous epithelial ovarian neoplasm. Elevated serum levels of CA 125 are also associated with other gynecological neoplasm's, primarily endometrium and fallopian tube carcinomas and certain tumors of the pancreas, liver, colon, breast and lung. Recent studies indicate that monitoring serial determinations of CA 125 in conjunction with chemotherapy may have clinical value in deciding proper prognosis. Studies also suggest that long term monitoring of CA 125 in patients with known ovarian carcinomas has utility in detecting early recurrence and disease progression. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 8, 32, 128, 500, 1100 U/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
2 - 1000 U/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK CA 125 |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK CA 125 CALIBRATOR SET
AIA-PACK CA 125 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.