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Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum / plasma Storage : 2 - 8 C Cat No : AE0710 INTENDED USE: The TRUSTwell HBsAg ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HBV. Any reactive specimen with the TRUSTwell HBsAg ELISA Kit must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: TRUSTwell HBsAg ELISA Kit is a solid phase enzyme linked immunosorbent assay based on the principle of antibody sandwich technique for the detection of HBsAg in human serum or plasma. The TRUSTwell HBsAg ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with monoclonal anti HBsAg antibody; 2) Liquid conjugates composed of polyclonal anti-HBsAg conjugated with horse radish peroxidase (HRP-HBsAb conjugates). During the assay, the test specimen and HRP-HBsAb conjugates are incubated simultaneously with the coated microwells. HBsAg, if present in the specimen, reacts to the anti-HBsAg antibody coated on the microwell surface as well as the HRPHBsAb conjugate, 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 absorbance are read using a spectrophotometer at 450 /620-690 nm. Clinical Performance: A total of 1033 patient specimens from susceptible subjects were tested by the TRUSTwell HBsAg ELISA Kit. Relative Sensitivity:100%, Relative Specificity:99.78%, Overall Agreement:99.81%
