Intended Use
The CK-MB/cTnI Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of CK-MB and cTnI in serum, plasma, or whole blood. This test is used as an aid in the clinical diagnosis, prognosis, and evaluation of myocardial injury such as Acute Myocardial Infarction (AMI), Unstable Angina, Acute Myocarditis, and Acute Coronary Syndrome (ACS).
About CK-MB/cTnI
CK-MB: Creatine kinases are dimer isozymes composed of two monomer subunits, CK-M (skeletal muscle-derived) and CK-B (brain-derived). These form three combinations: CK-BB, CK-MM, and CK-MB. CK-BB is found primarily in the brain, while skeletal muscles primarily contain CK-MM, with trace amounts of CK-MB (around 1-4% of total CK activity). Cardiac muscles contain higher amounts of CK-MB (around 20% of total CK activity), making CK-MB a more sensitive marker for myocardial injury than total CK activity due to its lower basal level and narrower normal range.
cTnI: The troponin complex consists of three regulatory proteins: T, which connects the troponin complex and tropomyosin; I, which prevents muscle contraction in the absence of calcium; and C, which binds calcium. Cardiac troponin I (MW 22.5 kDa) has a highly specific N-terminal sequence for myocardium, making it highly specific for diagnosing myocardial injury. Clinical studies demonstrate the release of cTnI into the bloodstream within hours following AMI or ischemic damage.
Specifications
Test Item:
CK-MB/cTnI
Sample:
Serum, Plasma, Whole Blood
Detection Range:
- CK-MB: 2.5~80.0 ng/mL
- cTnI: 0.1~50.0 ng/mL
Storage Condition:
4-30℃
Method:
Immunofluorescence Assay
Test Time:
10 min
Cut-off Values:
- CK-MB: 5.0 ng/mL
- cTnI: 0.1 ng/mL
Shelf Life:
24 months
Applicable Devices
- Getein 1100 Immunofluorescence Quantitative Analyzer
- Getein 1180 Immunofluorescence Quantitative Analyzer
- Getein 1600 Immunofluorescence Quantitative Analyzer
Clinical Applications
- Aid in the diagnosis and risk classification of ACS.
- Aid in diagnosing various myocardial injuries.
- Aid in evaluating thrombolysis treatment.
- Estimate the size of myocardial infarction.
- Detect the degree of myocardial injury during surgery.
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<h2>Specifications</h2>
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<th>Test Item</th>
<th>Sample</th>
<th>Detection Range</th>
<th>Storage Condition</th>
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<td>CK-MB/cTnI</td>
<td>P/S/WB</td>
<td>CK-MB: 2.5~80.0 ng/ml<br>cTnI: 0.1~50.0 ng/ml</td>
<td>4-30℃</td>
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<th>Method</th>
<th>Test Time</th>
<th>Cut-off Value</th>
<th>Shelf Life</th>
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<td>Immunofluorescence Assay</td>
<td>10 min</td>
<td>CK-MB: 5.0 ng/ml<br>cTnI: 0.1 ng/ml</td>
<td>24 months</td>
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