Diagnostic Kit for IgG ∕IgM Antibody to Dengue
1. INTEDED USE
This kit is used for in vitro qualitative detection of IgG/IgM antibody to dengue in human whole blood, serum or plasma sample, which's applicable to auxiliary diagnosis of dengue virus infection. This kit only provides detection results of IgG/IgM antibody to dengue, and results obtained shall be used in combination with other clinical information for analysis.
2. PRODUCT SPECIFICATION
| Model No. | DEN IgG/IgM |
| Methodology | Colloidal Gold |
| Sample Type | Blood |
| Time to Result | 15-20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE |
| MAIN KIT COMPONENTS: *Test device *Disposable pipette *Instructions for Use |
Packing: *25 test /kit *Aluminum foil bag labeling *shrink wrap |
3.TEST METHOD
| 1 |
Remove the reagent card from the foil bag and lay it flat on a level work surface and label it
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| 2 | Use disposable pipette provided to pipette sample. If serum or plasma sample is used, one can directly and vertically add 2 drops (approx. 80 µL) to the well without adding sample diluent and start counting time. If whole blood sample is used, vertically add 2 drops (approx. 80 µL) to the well, then turn sample diluent upside down,discard first 2 drops of sample diluent, vertically and slowly add 1 drop of bubble-free sample diluent dropwise to the well, and start counting time. |
| 3 | Test result shall be interpreted within 15~20 minutes, and interpretation result is invalid after 20 minutes. |
4.Result reading
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
