J. Mitra Dengue Day 1 Combo Kit

Dengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are four distinct but antigenically related serotypes of dengue viruses, and transmission is by mosquito, principally Aedes aegypti and Aedes albopictus. The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to sub-tropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondary infection is the more common form of the disease in many parts of Southeast Asia and South America. IgM antibodies are not detectable until 5-10 days in case of primary dengue infection and until 4-5 days in secondary infection after the onset of illness. IgG appear after 14 days and persist for life in case of primary infection and rise within 1-2 days after the onset of symptoms in secondary infection. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, hemorrhagic events, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels 0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in countries where dengue is endemic. 

Intended useDengue Day 1 Test is a rapid solid phase immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to dengue virus in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid to an early diagnosis of dengue infection & presumptive diagnosis between primary and secondary dengue infection.

Principle (antigen-antibody reaction)
Dengue Day 1 Test kit consists two devices; one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgM/ IgG antibodies in human serum/ plasma. Dengue NS1 antigen device contains two lines; “C” (Control Line) & “T” (Dengue NS1 Antigen detection Test Line). Test line is coated with antibodies, anti-dengue NS1 Ag. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloid conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at “T” as antibody-antigen-antibody gold conjugate complex. Dengue IgM/IgG test device contains three lines; “C” (Control line), “M” (IgM test line) & “G” (IgG test line). IgM test line is coated with anti-human IgM monoclonal antibodies and IgG test line is coated with anti-human IgG monoclonal antibodies. When a sample is added to the device, IgM and IgG antibodies in the sample react with anti-human IgM or IgG antibodies coated on the membrane respectively.