Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2 - 8 C Cat No : AE0610 INTENDED USE: The TRUSTwell Syphilis Ab kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of antibodies (IgG, IgM, IgA) against Treponema pallidum (Tp) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with Tp. Any reactive specimen with the TRUSTwell Syphilis Ab ELISA Test must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: The TRUSTwell Syphilis Ab ELISA Test is a solid phase enzyme linked immunosorbent assay based on the principle of the double antigen sandwich technique for the detection of antibodies to Tp in human serum or plasma. The TRUSTwell Syphilis Ab ELISA Test is composed of two key components: 1) Solid microwells pre-coated with recombinant Tp antigens; 2) Liquid conjugates composed of recombinant Tp antigens conjugated with horseradish peroxidase (HRP-Tp conjugates). During the assay, the test specimen and HRP-Tp conjugates are incubated simultaneously with the coated microwells. Antibodies (IgG, IgM, or IgA) to Tp if present in the specimen, reacts to the Tp antigens coated on the microwell surface as well as the HRP-Tp conjugates, forming sandwich complex 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 1132 patient specimens from susceptible subjects were tested by the TRUSTwell Syphilis Ab ELISA Kit. Relative Sensitivity:100%, Relative Specificity:99.8%, Overall Agreement:99.82%.