J. Mitra Dengue IGG Microlisa Kit

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. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, haemorrhagic 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 IgM antibody levels 3 to 5 days after the onset of symptoms; this generally persists for 30 to 60 days. IgG levels also become elevated after 10 to 14 days and remain detectable for life. During secondary infection, IgM levels generally rise more slowly and reach lower levels than in primary infection, while IgG levels rise rapidly from 1 to 2 days after the onset of symptoms.

Intended use
Dengue IgG Microlisa is designed for in-vitro qualitative detection of Dengue IgG Antibodies in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for DENGUE. The kit detects all four subtypes; DEN1, DEN2, DEN3 & DEN4 of Dengue Virus.

Principle
DENGUE IgG MICROLISA test is an enzyme immunoassay based on “GAC-Capture ELISA”. Anti-human IgG antibodies are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. Antibodies to Dengue if present in the specimen, will bind to the Anti-human IgG antibodies adsorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRPO) conjugated dengue antigen (DEN1-4) is added to each well. This dengue antigen conjugate will bind to Dengue specific IgG antibodies which is complexed with anti- human IgG antibodies. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of Dengue antibodies present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain Dengue IgG antibodies then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colour develops. 

Description of symbols used
The following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.