Diagnostic Kit for NS1 Antigen&IgG ∕IgM Antibody to Dengue
1. INTEDED USE
This kit is used for in vitro qualitative detection of NS1 antigen and IgG/IgM antibody to dengue in human serum,plasma or whole blood sample, which's applicable to auxiliary early diagnosis of dengue virus infection. This kit only provides detection results of NS1 antigen and IgG/IgM antibody to dengue, and results obtained shall be used in combination with other clinical information for analysis. This kit is for healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | DEN-NS1& IgG/IgM combo |
| 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
