Myoglobin detect kit for acute myocardial infarction
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection of myoglobin (MYO) in human serum/plasma/whole blood samples, and mainly used for auxiliary early diagnosis of acute myocardial infarction. The kit only provides test result of myoglobin (MYO). The obtained result shall be analyzed in combination with other clinical information. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | MYO |
| 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 182 clinical samples. Use the marketed kit of time-resolved immunofluorescence as the control reagent. Compare the test results. Use linear regression to investigate their comparability. Correlation coefficients of two tests are y = 0.989x+2.242 and R=0.9930 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
