| PRODUCT NAME: |
ST AIA-PACK cTnI 3rd-Gen |
| INTENDED USE: |
ST AIA-PACK cTnI 3rd-Gen is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of cardiac troponin I (cTnl) in human serum and heparinized plasma or EDTA plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Troponin I (TnI) has three isoforms: cardiac, fast skeletal and slow skeletal and out of them cardiac troponin I (cTnI) is highly specific to the myocardium. When the myocardium is damaged, cTnI is released into the blood. The level of cTnI becomes abnormally high 3-4 hours after the onset of acute myocardial infarction and reaches the peak 10-16 hours after the onset. The level of cTnI remains abnormally high for 5-8 days after the onset. When compared to Myoglobin or CK-MB, the degree of its change in relation to the cut-off value is much greater for cTnI (undetectable in healthy individuals) and as a result, it is possible to detect minute myocardial lesions. In addition, increased cTnI levels in heart failure patients indicates latent cardiomyopathy. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 0.2, 1.0, 5.0, 20, 60 ng/mL |
| Assay sample: |
Serum and heparinized plasma, EDTA plasma |
| Assay range: |
0.03 - 50 ng/mL |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK cTnI 3rd-Gen |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK cTnI 3rd-Gen CALIBRATOR SET
AIA-PACK cTnI 3rd-Gen 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.