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%.
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2-8 c Cat No : AE0311 INTENDED USE : The Dengue IgG ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of elevated anti-dengue viruses (DEN1, 2, 3, 4) IgG in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of active infection with dengue viruses, including secondary infection. TEST PRINCIPLE: The Dengue IgG ELISA Kit is a solid-phase enzyme-linked immunosorbent assay based on the principle of the capture immunoassay methodology for the detection of IgG anti-dengue virus in human serum or plasma. The Dengue IgG ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with mouse monoclonal anti-human IgG antibody. 2) Conjugate composed of biotinylated dengue antigens and avidin HRP-conjugates. During the assay, the test specimen is first incubated in the coated microwell. IgG antidengue, if present in the specimen, binds to the anti-human IgG antibodies coated on the microwell surface, and any unbound specimen is then removed by a wash step. During a second incubation with Biotinylated dengue antigens, the IgG anti-dengue absorbed on the surface of microwell binds with dengue antigen, forming a complex. Unbound antigens are then removed by washing. After addition of Streptavidin HRP conjugate, it binds with biotinylated antigen and forming complex with HRP conjugate. After addition of the TMB substrate, the presence of the conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. This reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm. Accuracy of Detection : A total of 262 patient specimens were collected from susceptible subjects and tested by Dengue IgG ELISA Kit and by a commercial leading brand EIA. Relative Sensitivity: 95.2% (95% Confidence Interval = 83.8 - 99.4%) Relative Specificity: 96.8% (95% Confidence Interval = 93.6 - 98.7%) Overall agreement: 96.6% (95% Confidence Interval = 93.6 - 98.4%)
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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%
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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 : 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 %).
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Bran : CTK BioTech Sample Material : serum or plasma Storage : 2-8 C Cat. No : AE0310 The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of IgM anti-dengue viruses (DEN1, 2, 3, 4) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of acute infection with dengue viruses. TEST PRINCIPLE: The Dengue IgM ELISA Kit is a solid-phase enzyme-linked immunosorbent assay based on the principle of the capture immunoassay methodology for the detection of IgM anti-dengue virus in human serum or plasma. The Dengue IgM ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with mouse monoclonal anti-human IgM antibody. 2) Conjugate working solution composed of dengue antigen and HRP-anti-dengue conjugates. During the assay, the test specimen is first incubated in the coated microwell. IgM antidengue, if present in the specimen, binds to the anti-human IgM antibodies coated on the microwell surface, and any unbound specimen is then removed by a wash step. During a second incubation with HRP-anti-dengue conjugate working solution, the IgM anti-dengue absorbed on the surface of microwell binds to the conjugate through dengue antigen, forming a conjugate complex. Unbound conjugates are then removed by washing. After addition of the TMB substrate, the presence of the conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. This reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm. Accuracy of Detection : A total of 491 patient specimens were collected from susceptible subjects and tested by Dengue IgM ELISA Kit and by a commercial leading brand EIA. Relative Sensitivity: 90.8% (95% Confidence Interval = 85.5 - 94.4%) Relative Specificity: 95.9% (93.1 - 97.7%) Overall Agreement: 94.1% (91.6 - 95.9%).