Uncut sheet for Carcino-embryonic Antigen Test
1. INTEDED USE
Diagnostic Kit for Carcino-embryonic Antigen (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Carcino-embryonic Antigen (CEA) in human serum or plasma, which is mainly used to observe the curative effect of malignant tumor, predict the prognosis and monitor the recurrence.All positive sample must be confirmed by other methodologies.
2. PRODUCT SPECIFICATION
| Model No. | CEA Uncut sheet |
| Methodology | fluorescence immunochromatographic assay |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking; |
| 2 | Add 30μL serum or plasma sample into sample diluent, and mix well,37℃water bath heated for 10 minutes. |
| 3 | Add 80μL mixture to sample well of the card |
| 4 | Click the "standard test" button,after 10 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
