Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : Serum / Plasma Storage : 2-8 C Cat No : AE0315 The TRUSTwell CHIK IgM Test is a solid phase enzyme linked immunoabsorbent assay for the qualitative detection of IgM anti- Chikungunya virus in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of acute infection with Chikungunya viruses. Any reactive specimen with the TRUSTwell CHIK IgM Test must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: TRUSTwell CHIK IgM Test is a solid phase enzyme linked immunoabsorbent assay based on the principle of the indirect immunoassay technique for the detection of IgM anti- Chikungunya virus in human serum or plasma. The TRUSTwell CHIK IgM Test is composed of two key components: 1) Solid microwells pre-coated with recombinant CHIK antigen(s); 2) Liquid conjugates composed of monoclonal anti-human IgM reagent conjugated with horse reddish peroxidase (HRP-anti-Human IgM conjugates). During the assay, the test specimen is first incubated with the coated microwells. IgM anti- Chikungunya virus, if present in the specimen, binds to the antigen coated on the microwell surface. In the second incubation with the HRP-anti Human IgM conjugates, the IgM antiChikungunya antibody absorbed on the surface of microwell reacts to the conjugates, forming a complexed conjugates. Unbounded conjugates are then removed by washing. The presence of the complexed conjugates is shown by a blue color upon additional incubation with TMB substrate. The reaction is stopped with Stop Solution and absorbances are read using a spectrophotometer at 450 /620-690 nm. Clinical Performance: A total of 336 specimens from susceptible subjects were tested by TRUSTwell CHIK IgM and by a commercial reference ELISA kits. Relative Sensitivity: 91.3 %, (95 % CI: 73.2 % -97.6 %) Relative Specificity: 96.8 %, (95 % CI: 94.2 % -98.3 %) Overall Agreement: 96.4%, (95 % CI: 93.9 % -98.0 %).