Dengue virus is a single-stranded RNA virus of about 50nm in diameter belonging to the genus Flavivirus. Dengue and dengue hemorrhagic fever are caused by one of four closely related, but antigenically distinct, virus serotypes (DENV-1, DENV-2, DENV-3, and DENV4). Infection with one of these serotypes does not provide cross-protective immunity, so persons living in a dengue-endemicarea can have four dengue infections during their lifetimes. The viruses are transmitted by Aedes aegypti, a domestic, day-biting mosquito that prefers to feed on humans. Infection with dengue viruses produces a spectrum of clinical illness ranging from anonspecific viral syndrome to severe and fatal hemorrhagic disease. It is primarily a disease of the tropics; its global distribution is comparable to that of malaria, and an estimated 2.5 billion people live in areas at risk for epidemic transmission. Globally, there are an estimated 50 to 100 million cases of dengue fever and several hundred thousand cases of dengue hemorrhagic fever. The case-fatality rate of DHF in most countries isabout 5%; most fatal cases are among children and young adults. Important risk factors for DHF include the strain and serotype of the infecting virus, as well as the age, immune status, and genetic predisposition of the patient.
Sample Type:Serum or plasma
Intended Use:The dengue virus IgG antibody ELISA BioAssay™ kit has been designed for the detection and the quantitative determination of specific IgG antibodies against dengue virus in human serum or plasma (citrate, heparin).
Cross Reactivity:Cross reactivity with other flaviviruses cannot be excluded and shouldbe taken into account for result interpretation.
Diagnostic Specificity:The diagnostic specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is 98% (95% confidence interval: 89.35-99.95%).
Diagnostic Sensitivity:The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 100% (95% confidence interval: 90.75-100%).
Test Principle:The qualitative immunoenzymatic determination of specific antibodies is based on the ELISA (Enzyme-linked Immunosorbent Assay) technique
Microplates are coated with specific antigens to bind corresponding antibodies of the sample. After washing the wells to remove all unbound sample material a horseradish peroxidase (HRP) labelled conjugate is added. This conjugate binds to the captured antibodies. In a second washing step unbound conjugate is removed. The immune complex formed by the bound conjugate is visualized by adding Tetramethylbenzidine (TMB) substrate which gives a blue reaction product
The intensity of this product is proportional to the amount of specific antibodies in the sample. Sulphuric acid is added to stop the reaction. This produces a yellow endpoint color. Absorbance at 450/620nm is read using an ELISA microwell plate reader.
Storage and Stability:Store kit components at 2-8°C Before use, all components should be allowed to warm up to ambient temperature (20-25°C) and mixed thoroughly. After use, the plate should be resealed, the bottle caps replaced and tightened and the kit stored at 2-8°C. The opened reagents are stable for 6 months after receipt when stored at 2-8°C.
