The Dengue Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of anti-dengue IgG, IgM antibodies and/or NS1 protein in human whole blood, serum, or plasma. This test serves as an aid in the diagnosis of primary and secondary Dengue infections.

Dengue is a viral infection transmitted by mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world, and causes up to 100 million infections annually. Classic dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash.

Primary dengue infection causes IgM antibodies to increase to a detectable level in 3 to 5 days after the onset of fever. IgM antibodies generally persist for 30 to 90 days. Most Dengue patients in endemic regions have secondary infections, resulting in high levels of specific IgG antibodies prior to or simultaneous with IgM response. Therefore, the detection of specific anti-Dengue IgM and IgG antibodies can also help to distinguish between primary and secondary infections.

NS1 is a highly-conserved glycoprotein that is present at high concentrations in the sera of dengue-infected patients in the early stages of infection.