Diagnostic kir for Carcino-embryonic Antigen
1. INTEDED USE
This kit is applicable to in vitro quantitative detection of carcino-embryonic antigen (CEA) in human serum/plasma/whole blood sample, which’s mainly used for observation of efficacy against malignancies as well as prediction, prognosis, and recurrence monitoring. This kit only provides carcino-embryonic antigen test results, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | CEA |
| 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 performance of this product’s assessed through collection of 165 cases of clinical samples. Marketed kit of electrochemiluminescence’s used as reference reagent. Detection results have been compared and their comparability has been studied through linear regression, and correlation coefficients of the two assays are Y=0.940X+2.249 and R=0.9889 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
7.GLOBAL PARTNER
