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: |
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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.