Product Details:
Number of Reactions(Preps)/Kit 96 Wells
Brand CTK BioTech
Sample serum or plasma
Storage 2 - 8 C
Cat No : AE0510
INTENDED USE:
The TRUSTwell HCV IgG ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of IgG to Hepatitis C virus (HCV) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HCV. Any reactive specimen with the TRUSTwell HCV IgG ELISA Kit must be confirmed with alternative testing method(s) and clinical findings.
TEST PRINCIPLE:
The TRUSTwell HCV IgG ELISA Kit is a solid phase enzyme linked immunosorbent assay based on the principle of the indirect EIA technique for the detection of the IgG to HCV in human serum or plasma. The TRUSTwell HCV IgG ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with recombinant HCV antigens; 2) Liquid conjugates composed of mouse anti-human IgG conjugated with horse radish peroxidase (HRP-anti Human IgG conjugates). During the assay, the test specimen is first incubated with the coated microwells. The IgG anti HCV, if present in the specimen, bind to the antigens coated on the microwell surface. In the second incubation with the HRP-anti-human IgG conjugates, the IgG antibodies absorbed on the surface of microwell react to the HRP-anti-human IgG 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 1108 patient specimens from susceptible subjects were tested by the TRUSTwell HCV IgG ELISA Kit.
Relative Sensitivity:100%,
Relative Specificity:99.81%,
Overall Agreement:99.82%.
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