Infection Disease Dengue iggigm Antibody Rapid Test with CE
certificate Test Device
| Product Name | Dengue IggIgm Antibody Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Dengue IgG/IgM Rapid Test is a lateral flow immunoassay for the
simultaneous detection and differentiation of IgG anti–dengue virus
and IgM anti-dengue virus in human whole blood, serum or plasma. It
is intended to be used by the professionals as a screening test and
as an aid in the diagnosis of infection with dengue viruses. Any
reactive specimen with the Dengue IgG/IgM Rapid Test must be
confirmed with alternative testing method(s).
INTRODUCTION
Dengue viruses, a family of four distinct serotypes of viruses (Den
1,2,3,4), are single-strained, enveloped, positive-sense RNA
viruses. The viruses are transmitted by mosquitoes of the daytime
biting Stegeman family, principally Aedes aegypti, and Aedes
albopictus. Today, more than 2.5 billion people living in the areas
of tropical Asia, Africa, Australia, and the Americas are at risk
for dengue infection. An estimated 100 million cases of dengue
fever and 250,000 cases of life-threatening dengue hemorrhagic
fever occur annually on a worldwide basis1-3.
Serological detection is a common method for the diagnosis of
infection with dengue viruses. IgM anti-dengue virus starts to
appear at 3 days after initial exposure and remain in the
circulation for about 30-60 days. IgG anti-dengue virus raise at
around 7 days, peak at 2-3 weeks, and persist for the life4-6.
The Dengue IgG/IgM Rapid Test detects IgG and IgM anti-dengue virus
in one test within 25 minutes. The test is user friendly, without
cumbersome laboratory equipment, and requires minimal staff
trainings.
PERFORMANCE CHARACTERISTICS
1. Clinical Performance For IgM Test
A total of 314 patient samples from susceptible subjects were
tested by the Dengue IgG/IgM Rapid Test and by a reference EIA.
Comparison for all subjects is showed in the following table:
| Dengue IgG/IgM Rapid Test | |
| IgM EIA Test | Positive | Negative | Total |
| Positive | 31 | 1 | 32 |
| Negative | 3 | 279 | 282 |
| Total | 34 | 280 | 314 |
Relative Sensitivity: 96.9%, Relative Specificity: 98.9%, Overall
Agreement: 98.7%
2. Clinical Performance For IgG Test
A total of 326 patient samples from susceptible subjects were
tested by the Dengue IgG/IgM Rapid Test and by a reference EIA.
Comparison for all subjects is showed in the following table:
| Dengue IgG/IgM Rapid Test | |
| IgG EIA Test | Positive | Negative | Total |
| Positive | 36 | 1 | 37 |
| Negative | 2 | 287 | 289 |
| Total | 38 | 288 | 326 |
Relative Sensitivity: 97.3%, Relative Specificity: 99.3%, Overall
Agreement: 99.1%
