Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2-8 c Cat No : AE0311 INTENDED USE : The Dengue IgG ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of elevated anti-dengue viruses (DEN1, 2, 3, 4) IgG in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of active infection with dengue viruses, including secondary infection. TEST PRINCIPLE: The Dengue IgG ELISA Kit is a solid-phase enzyme-linked immunosorbent assay based on the principle of the capture immunoassay methodology for the detection of IgG anti-dengue virus in human serum or plasma. The Dengue IgG ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with mouse monoclonal anti-human IgG antibody. 2) Conjugate composed of biotinylated dengue antigens and avidin HRP-conjugates. During the assay, the test specimen is first incubated in the coated microwell. IgG antidengue, if present in the specimen, binds to the anti-human IgG antibodies coated on the microwell surface, and any unbound specimen is then removed by a wash step. During a second incubation with Biotinylated dengue antigens, the IgG anti-dengue absorbed on the surface of microwell binds with dengue antigen, forming a complex. Unbound antigens are then removed by washing. After addition of Streptavidin HRP conjugate, it binds with biotinylated antigen and forming complex with HRP conjugate. After addition of the TMB substrate, the presence of the conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. This reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm. Accuracy of Detection : A total of 262 patient specimens were collected from susceptible subjects and tested by Dengue IgG ELISA Kit and by a commercial leading brand EIA. Relative Sensitivity: 95.2% (95% Confidence Interval = 83.8 - 99.4%) Relative Specificity: 96.8% (95% Confidence Interval = 93.6 - 98.7%) Overall agreement: 96.6% (95% Confidence Interval = 93.6 - 98.4%)