Uncut sheet for Dengue NS1 Antigen &lgG/igM Antibody combo Test
1. INTEDED USE
The Dengue NS1 Antigen and IgG/IgM Antibody Rapid Test Device (the “uncut sheet” format for manufacturing use) is intended for the qualitative and differential detection of dengue virus NS1 antigen and dengue virus-specific IgG and IgM antibodies in human serum, plasma, or whole blood specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the early diagnosis of dengue virus infection in patients presenting with clinical signs and symptoms suggestive of dengue fever. The combined detection of NS1 antigen and serological antibodies (IgM/IgG) extends the diagnostic window across different stages of infection, enabling more comprehensive assessment of both early and recent infection.
The test employs a double antibody sandwich immunochromatographic assay using colloidal gold conjugation.
The device provides presumptive screening test results, results obtained shall be usecin combination with other clinical information for analysis.
This product is intended for use by trained healthcare professionals or laboratory personnel, is for manufacturing use only and is intended for further processing into final device format.
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 |
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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
6.EXHIBITION
