Cardiac CK-MB Rapid One Step Test with CE certificate Test Device
| Product Name |
Cardiac CK-MB One Step Test
|
| Formats |
Strip(3mm)Device(4mm) |
| Place of Origen |
China |
| Specimen |
Blood |
| Read Time |
15 minutes |
| Shelf life |
2 years |
| Package |
25 device/box or 50 strip/Box |
| Storage |
2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human CK-MB in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Sensitivity and Specificity
The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial CK-MB EIA test using clinical specimens. The results show that the sensitivity of the CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 99.8% relative to the leading EIA test.
CK-MB Rapid Test vs. EIA
| Method |
EIA |
Total
Results
|
| CK MB Rapid Test |
Results |
Positive |
Negative |
| Positive |
55 |
1 |
56 |
| Negative |
0 |
425 |
425 |
| Total Results |
55 |
426 |
481 |
Relative Sensitivity: 100% (93.5%-100.0%) *
Relative Specificity: 99.8% (98.7%-99.9%)*
Accuracy: 99.8%(98.9% to 99.9%)* 95% Confidence Interval
SUMMARY
Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa.1 Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B” which combine to form three different isoenzymes, CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.2 The release of CK-MB into the blood following MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours.3 CK MB is one of the most important cardiac markers and is widely recognized as the traditional marker for the diagnosis of MI.
The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-CK-MB antibody coated particles and capture reagent to detect CK-MB in whole blood, serum or plasma. The minimum detection level is 5 ng/mL.
Product Tags:
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Cardiac CKMB Blood Test LFT Lateral Flow Test 99.8% Accuracy Images
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