| PRODUCT NAME: |
ST AIA-PACK AFP |
| INTENDED USE: |
ST AIA-PACK AFP is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of alpha-fetoprotein (AFP) in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Alpha-fetoprotein (AFP) is a fetal globulin synthesized by the fetal liver, gastrointestinal tract and yolk sac. Within a year after birth, AFP in a normal serum is decreased to a barely detectable level. Elevated serum AFP levels may be observed in patients with nonseminomatous testicular carcinoma. A few other common cancers, usually with hepatic metastasis, increase AFP levels. These include carcinoma of stomach, gallbladder, prostrate and bronchi. Increase AFP levels have also been reported in non-malignant diseases. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 200 ng/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
1 - 400 ng/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK AFP |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK AFP CALIBRATOR SET
AIA-PACK AFP 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.