Infection Disease Dengue NS1 Rapid Test with CE certificate uncut
sheet
| Product Name | Dengue NS1 Rapid Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Dengue NS1 Rapid Test Device is a lateral flow chromatographic
immunoassay for the qualitative detection of dengue virus antigen
(Dengue Ag) in human whole blood, serum or plasma. It is intended
to be used as a screening test and as an aid in the diagnosis of
infection with Dengue viruses. Any reactive specimen with the
Dengue NS1 Rapid Test Device must be confirmed with alternative
testing method(s) and clinical findings.
PERFORMANCE CHARACTERISTICS
Clinical Performance
A total of 114 patient samples from susceptible subjects were
tested by the Dengue NS1 Rapid Test and by a commercial EIA.
Comparison for all subjects is showed in the following table:
| Dengue NS1 Rapid Test | |
| Dengue Ag EIA Test | Positive | Negative | Total |
| Positive | 66 | 3 | 69 |
| Negative | 2 | 43 | 45 |
| Total | 68 | 46 | 114 |
Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall
Agreement: 95.6%
TEST PRINCIPLE
The Dengue NS1 Rapid Test is a lateral flow chromatographic
immunoassay. The test cassette consists of: 1) a burgundy colored
conjugate pad containing mouse anti-dengue NS1 antigen conjugated
with colloid gold (Dengue Ab conjugates), 2) a nitrocellulose
membrane strip containing a test band (T band) and a control band
(C band). The T band is pre-coated with rabbit anti-dengue NS1
antigen, and the C band is pre-coated with goat anti-mouse IgG
antibody. The antibodies to dengue antigen recognize the antigens
from all the four serotypes of the dengue virus.
When an adequate volume of test specimen is dispensed into the
sample well of the cassette, the specimen migrates by capillary
action across the test cassette. Dengue NS1 Ag if present in the
specimen will bind to the Dengue Ab conjugates. The immunocomplex
is then captured on the membrane by the pre-coated rabbit anti-NS1
antibody, forming a burgundy-colored T band, indicating a Dengue Ag
positive test result. Absence of the T band suggests a negative
result. The test contains an internal control (C band) which should
exhibit a burgundy-colored band of the immunocomplex of goat
anti-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T
band. Otherwise, the test result is invalid, and the specimen must
be retested with another device.
