High-throughput treponema pallidum specific antibody detection kit and preparation method thereof
The technology of Treponema pallidum and detection kit is applied in the directions of measuring devices, instruments, scientific instruments, etc., which can solve the problems of low sensitivity, low detection positive rate and high false positive rate of cardiolipin antibody, and achieves accurate results, simple operation, The effect of sensitive detection
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Embodiment 1
[0037] see figure 1 , the embodiment of the Treponema pallidum-specific antibody high-throughput detection kit is provided with an outer packaging box 1, an alkaline phosphatase-labeled anti-human γ monoclonal antibody bottle 2, an alkaline phosphatase-labeled anti-human μ monoclonal antibody bottle 3 , alkaline phosphatase-labeled anti-human Ig monoclonal antibody bottle 4, luminescent substrate bottle 5, Treponema pallidum-specific antibody negative control bottle 6, Treponema pallidum-specific IgG antibody positive control bottle 7, Treponema pallidum-specific IgM positive 8 bottles of reference substance, 9 bottles of positive reference substance specific for Treponema pallidum specific antibodies, 10 bottles of washing solution, 11 bottles of recombinant antigen-coated microwell plates; 2 bottles of alkaline phosphatase-labeled anti-human γ monoclonal antibody, alkaline phosphatase-labeled Anti-human μ monoclonal antibody vial 3, alkaline phosphatase-labeled anti-human Ig...
Embodiment 2
[0064] The following shows the use of the Treponema pallidum-specific antibody high-throughput detection kit to detect the Treponema pallidum-specific antibody in clinical samples of patients:
[0065] 1. Specimen processing: Serum: 5mL of venous blood, placed in a 37°C water bath for 30 minutes, centrifuged at 3000g for 10 minutes, and the supernatant was used as a test sample for later use.
[0066] 2. Adding samples: add 100 μL of samples to the reaction plate, and make blank, negative and positive control wells at the same time. Incubate at 37°C for 1h.
[0067] 3. Washing: After reacting at 37°C for 30 minutes, the measured syphilis-specific antibody binds to the syphilis-specific recombinant antigen coated on the microwell plate, and the unbound free components are separated by washing;
[0068] 4. Add alkaline phosphatase-labeled anti-human gamma monoclonal antibody (to detect Treponema pallidum-specific IgG antibody), alkaline phosphatase-labeled anti-human μ monoclon...
Embodiment 3
[0070] The performance test of the Treponema pallidum-specific antibody high-throughput detection kit is given below
[0071] (1) Conformity rate of positive samples
[0072] Use 50 positive reference sera of syphilis-specific antibodies to test, and calculate the positive coincidence rate.
[0073] (2) Negative specimen coincidence rate
[0074] Use 50 samples of syphilis-specific antibody-negative reference sera to test, and calculate the negative coincidence rate.
[0075] (3) Intra-batch variance
[0076] The same batch of kits is tested with characteristic serum, requiring CV ≤ 10%.
[0077] (4) Difference between batches
[0078] Different batches of kits are tested with characteristic serum, requiring CV ≤ 12%.
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