| PRODUCT NAME: |
AIA-PACK B12 |
| INTENDED USE: |
AIA-PACK B12 is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of vitamin B12 in human serum on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Vitamin B12 (cyanocobalamin) is essential for metabolism of fatty acids, intermediary metabolism of folic acid and the biosynthesis of DNA and RNA. Deficiency of vitamin B12 may be produced by any of several factors, including inadequate dietary intake and malabsorption. It is associated with auto-immune disorders (pernicious anemia), gastric disorders and damage or absence of terminal ileum. Vitamin B12 deficiency can produce serious progressive neurological disorders and macrocytic or megaloblastic anemia. Hence B12 serves as an important marker for diagnosis and monitoring of anemia. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Competitive enzyme immunoassay |
| Calibrators: |
0, 100, 250, 500, 1000, 2100 pg/mL |
| Assay sample: |
Serum |
| Assay range: |
84 - 2100 ng/mL |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
AIA-PACK B12 |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK B12 CALIBRATOR SET
AIA-PACK B12 SAMPLE DILUTING SOLUTION
AIA-PACK B12 PRETREATMENT SET
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.