Pro-brain natriuretic peptide to amino-terminal Diagnostic Kit
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection of N-terminal pro-B type natriuretic peptide (NT-proBNP) content in human serum/plasma/whole blood samples, for auxiliary diagnosis of heart failure. The kit only provides test result of NT-proBNP. The obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | NT-proBNP |
| 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 160 clinical samples. The results are compared by using the corresponding kit of marketed electrochemiluminescence method as the control reagent. Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y = 0.999X +32.880 and R=0.9854, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
