Cardiac Troponin I detection kit Acute Myocardial Infarction
1. INTEDED USE
This kit is intended for in vitro quantitative detection on the content of cardiac troponin I (cTnI) in human serum/plasma/whole blood sample and is intended for auxiliary diagnosis of myocardial infarction. This kit only provides cardiac troponin I (cTnI) test result, and the obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | cTnI |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | Serum/Plasma/Whole blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS
* Test device * Sample diluents * Instructions for Use |
PACKING
* 25 test /kit * Aluminum foil bag labeling * shrink wrap |
3.TEST METHOD
4.CLINICAL PERFORMANCE
Clinical evaluation performance of the product is assessed through collecting 150 clinical samples. The results are compared by using the corresponding kit of marketed chemiluminescence method as the reference reagent. Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y=0.948X+0.118 and R=0.9818, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
