Intended Use
The dengue fever ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to dengue, in samples of human serum or plasma. This test is intended to be performed by trained medical technologists only.
Assay Principle
The microwells are coated with purified dengue virus antigen from cell-cultured type 1-4 dengue. During the first incubation with the diluted patients sera, any antibodies which are reactive with the antigen will bind to the coated wells. After washing to remove the rest of the sample, the Enzyme Conjugate is added. If antibodies have been bound to the wells, the Enzyme Conjugate will then bind to these antibodies. After another series of washes, a chromogen (tetramethylbenzidine or TMB) is added. If the Enzyme Conjugate is present, the peroxidase will catalyze a reaction that consumes the peroxide and turns the chromogen from clear to blue. The addition of the Stop Solution ends the reaction and turns the blue color to a bright yellow color. The reaction may then be read visually or with an ELISA reader.
Dengue Fever Rapid IgG/IgM is an immunochromatographic assay designed for the qualitative detection and differentiation of specific IgM and IgG antibodies to dengue virus in human serum or plasma. It is intended to be used as in vitro diagnostic of dengue fever. The test provides a differential detection of anti-dengue IgM and anti-dengue-IgG antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection. The results obtained should not be the sole determinant for clinical decision.
Dengue virus, a virus belonging to the Flavavirus group of viruses, is one of the most significant mosquito-borne diseases in the world in terms of morbidity and mortality. Transmitted principally by the mosquito types Aedes aegypti and Aedes albopictus, the virus is found commonly throughout the tropic and sub-tropic regions of the world. There are four known serotypes of dengue. Symptoms of dengue fever include high fever, headache, muscle pain and skin rash. The complications often associated with this infection are dengue hemorrhagic fever or dengue shock syndrome.
The Dengue Fever Rapid IgG/IgM is an indirect solid-phase immunochromatographic assay. Serum or plasma samples may be used with this test.
When a specimen is added to the test device, IgG and IgM antibodies in the specimen sample, if present, will react with particles coated with dengue envelope proteins to form a complex. As this complex migrates along the length of the cellulose nitrate membrane, the anti-dengue IgG or IgM antibody particle complex is captured by the relevant IgG and/or IgM test bands located in the test device window causing a pale to dark pink purplish band to form at the IgG or IgM region of the test device window.
The intensity of the bands will vary depending upon the amount of antibody present in the sample. The appearance of any color in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM). A pink-purplish procedural control band should always develop in the test device window to indicate that the test has been performed properly.
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