Uncut sheet for Dengue NS1 Antigen &lgG/igM Antibody combo Test
1. INTEDED USE
This kit is used for in vitro qualitative detection of NS1 antigen and lgG/lg antilbody to dengue in human serumplasma or whole blood sample, which's applicable to auxiliary early diagnosis of dengue virus infection. This kitonly provides detection results of Ns1 antigen and lgG/lgl antibody to dengue, and results obtained shall be usecin combination with other clinical information for analysis. This kit is for healthcare professionals
2. PRODUCT SPECIFICATION
| Model No. | Dengue NS1 Antigen & lgG/lgM Antibody combo test Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | whole blood/Serum/Plasma |
| 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 detection reagent and sample to be detected from storage condition and equilibrate them to room temperature. |
| 2 | Open aluminum foil pouch of reagent, take out test device, and place it horizontally on laboratory bench; |
| 3 | Use disposable pipette provided to pipette sample. lf serum or plasma sample is usedD2one can directly and vertically add 8 drops (approx 80 μL) to "D1" well without addingsample diluent and start counting time. lf whole blood sample is used, vertically add 8drops (approx 80 uL) to "D1" well, then term sample diluent upside down, discard first 2drops of sample diluent, vertically and slowly add 1 drop of bubble-free sample diluent dropwise to "D1" wel, and start counting time. |
| 4 |
Result shall be interpreted within 15~ 20 minutes, and detection result is invalid after 20 minutes.
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4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
