Uncut sheet for Dengue NS1 Antigen Den-NS1 Rapid test
1. INTEDED USE
The Dengue NS1 Antigen Rapid Test ( Uncut sheet for manufacturing use) is a rapid Colloidal Gold intended for the qualitative detection of dengue virus non-structural protein 1 (NS1) antigen in human serum, plasma, or venous 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 dengue NS1 antigen is a highly conserved glycoprotein that is secreted into the bloodstream during viral replication. It is detectable from the first day of fever onset and can remain detectable for up to 7–9 days, making it a useful biomarker for acute-phase dengue diagnosis . The test detects NS1 antigen from all four dengue virus serotypes (DENV-1, -2, -3, and -4)
The test provides presumptive (preliminary) screening test results. Negative results do not rule out dengue virus infection, particularly if the specimen is collected outside the acute phase or in secondary infections where NS1 sensitivity may be reduced . Negative or equivocal results should be confirmed by alternative diagnostic methods such as RT-PCR or by testing a convalescent-phase specimen for dengue IgM antibodies . Positive results confirm dengue virus infection but do not provide serotype information; serotype determination, if required for surveillance purposes, should be performed by nucleic acid amplification tests .
This product is intended for use by trained healthcare professionals or laboratory personnel.
2. PRODUCT SPECIFICATION
| Model No. | Dengue NS1 Antigen 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
