Infection Disease Dengue iggigm Antibody Rapid Test with CE certificate Test Device

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 basis^1-3.

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 life^4-6.

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:

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:

Relative Sensitivity: 97.3%, Relative Specificity: 99.3%, Overall Agreement: 99.1%