Product Details: Number of Reactions(Preps)/Kit : 96 Wells Bran : CTK BioTech Sample Material : serum or plasma Storage : 2-8 C Cat. No : AE0310 The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of IgM anti-dengue viruses (DEN1, 2, 3, 4) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of acute infection with dengue viruses. TEST PRINCIPLE: The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay based on the principle of the capture immunoassay methodology for the detection of IgM anti-dengue virus in human serum or plasma. The Dengue IgM ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with mouse monoclonal anti-human IgM antibody. 2) Conjugate working solution composed of dengue antigen and HRP-anti-dengue conjugates. During the assay, the test specimen is first incubated in the coated microwell. IgM antidengue, if present in the specimen, binds to the anti-human IgM antibodies coated on the microwell surface, and any unbound specimen is then removed by a wash step. During a second incubation with HRP-anti-dengue conjugate working solution, the IgM anti-dengue absorbed on the surface of microwell binds to the conjugate through dengue antigen, forming a conjugate complex. Unbound conjugates are then removed by washing. 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 491 patient specimens were collected from susceptible subjects and tested by Dengue IgM ELISA Kit and by a commercial leading brand EIA. Relative Sensitivity: 90.8% (95% Confidence Interval = 85.5 - 94.4%) Relative Specificity: 95.9% (93.1 - 97.7%) Overall Agreement: 94.1% (91.6 - 95.9%).