| PRODUCT NAME: |
ST AIA-PACK CK-MB |
| INTENDED USE: |
ST AIA-PACK CK-MB is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of creatine kinase MB isoenzyme (CK-MB) in human serum on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
There are three major isozymes of Creatine Kinase (CK): CK-MM, CK-MB and CK-BB, which are found in many human tissues. Level of MM is high in skeletal muscles, MB is high in the myocardium and BB is high in the brain and smooth muscles, hence isozyme analysis can ascertain which organ is most likely affected when serum CK activity is elevated. Like Myoglobin, CK-MB is released by necrotic (damaged) myocardium, but since it goes through the lymphatic system, its level becomes abnormally high 4-6 hours after the onset of acute myocardial infarction. When compared to Myoglobin, the myocardial specificity of CK-MB is higher, and because the peak value of CK-MB correlates well with the severity of myocardial necrosis, it is possible to estimate the size of infarction. Furthermore, CK-MB has been shown to be useful in assessing reperfusion and monitoring of re-infarction. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 10, 20, 100, 200, 550 ng/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
0.5 - 500 ng/mL |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK CK-MB |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK CK-MB CALIBRATOR SET
AIA-PACK CK-MB 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.