Product Details:
Number of Reactions(Preps)/Kit : 96 Wells
Brand : CTK BioTech
Sample : serum / plasma
Stroage : 2-8 C
Cat No : AE0410
INTENDED USE:
The TRUSTwell HIV 1+2 Ab ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of anti-HIV-1 including subtype O and anti-HIV-2 antibodies (including isotype IgG, IgM and IgA) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HIV-1 and HIV-2 viruses. Any reactive specimen with the TRUSTwell HIV 1+2 Ab ELISA Kit must be confirmed with alternative testing method(s) and clinical findings.
TEST PRINCIPLE :
TRUSTwell HIV 1+2 Ab ELISA Kit is a solid phase enzyme linked immunosorbent assay based on the principle of the double antigen-sandwich technique for the detection of the various antibodies against HIV-1 and/or HIV-2 in human serum or plasma. The TRUSTwell HIV 1+2 Ab ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with recombinant HIV-1 and HIV-2 antigens; 2) Liquid conjugates composed of recombinant HIV-1 and HIV-2 antigens conjugated with horse radish peroxidase (HIV 1+2 HRP conjugates). During the assay, the test specimen is first incubated with the coated microwells. The anti-HIV-1 and anti-HIV-2 antibodies, if present in the specimen, bind to the antigens coated on the microwell surface. In the second incubation with the HRP- HIV 1+2 conjugates, the anti-HIV-1 and antiHIV-1 antibodies absorbed on the surface of microwell react to the HRP-HIV 1+2 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 1095 patient specimens from susceptible subjects were tested by the TRUSTwell HIV 1+2 Ab ELISA Kit.
Relative Sensitivity: 100% Relative Specificity: 99.9%, Overall Agreement: 99.9%
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