Infection Disease Dengue NS1 Rapid Test with CE certificate Test
Device
| Product Name | Dengue NS1 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 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.
SUMMARY AND EXPLANATION OF THE TEST
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-bitting Stegemyia 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 of IgM antibody is the most common method for
the diagnosis of dengue virus infection. Lately, detection of
antigens released during virus replication in the infected patient
showed very promising result. It enables diagnosis from the first
day after the onset of fever up to day 9, once the clinical phase
of the disease is over, thus allows early treatment in placed
promptly4.
The Dengue NS1 Rapid Test is developed to detect circulating dengue
antigen in human whole blood, serum or plasma. The test can be
performed by untrained or minimally skilled personnel, without
laboratory equipment.
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%
