| PRODUCT NAME: |
ST AIA-PACK BMG |
| INTENDED USE: |
ST AIA-PACK BMG is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of β2 microglobulin (BMG) in human serum, heparinized plasma and urine on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Human BMG is a single polypeptide that is shed from the cell membrane of all nucleated cells. In general, BMG can easily pass the glomerular basement membrane and in the renal tubule most of it is reabsorbed and catabolized. Therefore, when reabsorption by the renal tubule is hindered, a large amount of BMG is excreted in urine. On the other hand if glomerular filtration rate (GFR) is reduced, the level of BMG in the blood increases, making it possible to differentiate the two diseases. The level of urinary BMG is elevated in diseases such as heavy metal poisoning, Fanconi syndrome and Wilson’s disease, while the level of serum BMG is elevated in diseases such as chronic nephritis, nephrotic syndrome, malignant tumor and autoimmune disease. BMG assay has been applied to the diagnosis, monitoring and prognostication of these diseases. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 0.0125, 0.05, 0.15, 0.30, 0.42 mg/L |
| Assay sample: |
Serum and heparinized plasma and urine |
| Assay range: |
Original sample: 0.002 - 0.4 mg/L
Serum, heparinized plasma (51 times dilution): 0.1 - 20 mg/L
Urine (5 times dilution): 0.1 - 2 mg/L |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
AIA-PACK BMG |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK BMG CALIBRATOR SET
AIA-PACK BMG SAMPLE DILUTING CONCENTRATE
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.