C-reactive protein CRP rapid test
1. INTEDED USE
This kit is applicable to the vitro quantitative detection of C-reactive protein (CRP) in human serum/plasma/whole blood samples, for auxiliary diagnosis of acute and chronic inflammation or infection. This kit only provides the test result of C-reactive protein, and the obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | CRP |
| 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 178 clinical samples.
Use acorresponding marketed immunoturbidimetry kit as the control reagent and compare the test results.
Use linear regress to investigate their comparability. The correlation coefficients of the two tests are Y=1.050X-0.854 and R=0.9874, respectively
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
7.GLOBAL PARTNER
