Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| Storage | 2℃-30℃ |
| Sample Type | Blood |
| User | Professional |
| Accuracy | 99.8%(98.9% to 99.9%) |
| Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box |
| After-sales Service | Available |
| Key words | Cardiac CK-MB Rapid One Step Test with CE certificate Test Device |
| Combo Device | Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette |
| Brand Name | Aichek |
| Model Number | CKMB-A01 |
| Certification | CE |
| Place of Origin | China |
View Detail Information
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | Storage | 2℃-30℃ |
| Sample Type | Blood | User | Professional |
| Accuracy | 99.8%(98.9% to 99.9%) | Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable | Formats | 25T/box 1T/box |
| After-sales Service | Available | Key words | Cardiac CK-MB Rapid One Step Test with CE certificate Test Device |
| Combo Device | Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette | Brand Name | Aichek |
| Model Number | CKMB-A01 | Certification | CE |
| Place of Origin | China | ||
| High Light | Cardiac CKMB Blood Test ，CKMB LFT Lateral Flow Test ，99.8% Accuracy CKMB Blood Test | ||
| 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.
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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