Infection Disease Dengue NS1 Rapid Test with CE certificate Test Device

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 basis^1-3.

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:

Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall Agreement: 95.6%