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 | 98.1% (96.3%-99.2%) |
| Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box |
| After-sales Service | Available |
| Key words | Cardiac Myoglobin Rapid One Step Test uncut sheet |
| Combo Device | available |
| Brand Name | Aichek |
| Model Number | MYO-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 | 98.1% (96.3%-99.2%) | Certificate | CE ISO 13485 |
| OEM | OEM customized packing avaliable | Formats | 25T/box 1T/box |
| After-sales Service | Available | Key words | Cardiac Myoglobin Rapid One Step Test uncut sheet |
| Combo Device | available | Brand Name | Aichek |
| Model Number | MYO-A01 | Certification | CE |
| Place of Origin | China | ||
| High Light | Cardiac Myoglobin Uncut Sheet ，Uncut Sheet Rtk Blood Test ，Uncut Sheet Rapid Test ISO13485 | ||
| Product Name |
Cardiac Myoglobin One Step Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Sensitivity and Specificity
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial Myoglobin EIA test using clinical specimens. The results show that the sensitivity of the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 97.8% relative to the leading EIA test.
Myoglobin Rapid Test vs. EIA
| Method | EIA |
Total Results |
||
| Myoglobin Rapid Test | Results | Positive | Negative | |
| Positive | 59 | 8 | 67 | |
| Negative | 0 | 356 | 356 | |
| Total Results | 59 | 364 | 423 | |
Relative Sensitivity: 100% (94.0%-100%)*
Relative Specificity: 97.8% (95.7%-99.0%)*
Accuracy: 98.1% (96.3%-99.2%)* 95% Confidence Interval
Precision
Intra-Assay
Within-run precision has been determined by using replicates of 10 tests for each of three lots using Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL, and 400 ng/mL. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 3 independent assays on the same five specimens: 0ng/mL, 50ng/mL, 100 ng/mL, 200 ng/mL, and 400 ng/mL of Myoglobin. Three different lots of the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/ Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.
Interfering Substances
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been tested and no interference was observed in specimens containing 110 mg/mL human albumin, 6 mg/mL bilirubin, 10 mg/mL hemoglobin, 5 mg/mL cholesterol and 15 mg/mL triglycerides.
The following compounds have also been tested using the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) and no interference was observed.
| Acetaminophen | Creatine | Metoprolol Tartrate |
| Acetoacetic Acid | Diclofenac | Moracizine Hydrochloride |
| Acetylsalicylic acid | Digoxin | Nifedipine |
| Anisodamine | DL-Tyrosine | Oxalic Acid |
| Ascorbic Acid | Ethanol | Oxazepam |
| Atenolol | Felodipine | Pentoxifyline |
| Atorvastatin Calcium | Flunarizine Hydrochloride | Phenobarbital |
| Caffeine | Furosemide | Quinine |
| Captopril | Gentisic Acid | Ramipril |
| Chloramphanicol | Hydrochlorothiazide | Verapamil |
| Chlordiazepoxide | Isosorbide Mononitrate | |
| Cilazapril | Labetalol |
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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