Uncut Sheet for Immunofluorescence Assay CK-MB/cTnI/Myo Combo Test Kit
1. INTEDED USE
This test kit is suitable for quantitative detectionof cardiac troponin W/Isoenzyme MB of creatinekinase/myoglobin (cTnl/CK-MB/MYO) in humanserum, plasma whole blood sample in vitro,which is mainly used to auxiliary diagnosis ofmyocardial infarction. The test result should beanalyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | CK-MB/MYO/CTNI Uncut sheet |
| Methodology | Fluorescence |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15 mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 5 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Take out the test device from sealed foil pouch and place on a dry, clean and level surface. |
| 2 | Be sure to label the device with specimen’s ID number. |
| 3 | Fill the pipette dropper with the specimen. Hold the dropper vertically and transfer 1 drop of whole blood/serum/plasma specimen (approximately 10 μL) into the specimen well (S) , and make sure that there are no air bubbles. Then add 3 drops of sample diluent (approximately 80-100 μL) into the diluent well (D) immediately. See illustration below. |
| 4 | Start the timer. |
| 5 | Wait for the colored line(s) to appear. Read test results at 15 minutes. Positive results maybe visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
