Anti-LKM (liver-kidney microsomal) 1 antibody detection kit and detection method
A technology for antibody detection and microsomes, which is applied in the direction of biological testing, measuring devices, material inspection products, etc., can solve the problems of unsuitable laboratories, cross-contamination of reagents, complicated operation, etc., and achieve shortened detection time, simple and convenient operation, good stability effect
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Embodiment 1
[0034] Provides an anti-liver-kidney microsome 1 antibody detection kit, including biotinylated LKM-1 antigen (R1), calibrator, quality control, AP-anti-human IgG antibody (R2), magnetic particle reagent (M), Chemiluminescence substrate and wash solution. The biotinylated LKM-1 antigen is an LKM-1 antigen coupled with biotin. The AP-anti-human IgG antibody is an AP-labeled anti-human IgG antibody, in which alkaline phosphatase AP is coupled to an anti-human IgG antibody. The magnetic particle reagent is nano magnetic particle suspension with avidin SA group on the surface.
[0035] The biotinylated LKM-1 antigen is biotin and -NH on the surface of the LKM-1 antigen molecule 2 obtained by group reaction. The calibrator is prepared from human serum containing anti-LKM-1 antibody to obtain a calibration curve; the quality control product is prepared from human serum containing anti-LKM-1 antibody. The diameter of the magnetic particle in the magnetic particle reagent is 0.1-0...
Embodiment 2
[0038] Performance evaluation of the anti-liver-kidney microsome 1 antibody detection kit of the present invention:
[0039] (1) Sample comparison
[0040]Negative and positive coincidence rate: The kit of the present invention detects the content of anti-LKM-1 antibody in 217 cases of clinical serum, and conducts clinical comparison with similar products of well-known foreign companies. The comparison results are shown in the table below. The results showed that the positive coincidence rate of the anti-LKM-1 antibody kit of the present invention was 90.0% (45 / 50), and the negative coincidence rate was 99% (211 / 213), indicating that the clinical coincidence rate of the kit is high.
[0041]
[0042] (2) Sensitivity: The LOD of this detection kit is 0.145RU / mL, while the sensitivity of ELISA is 2RU / mL.
[0043] (3) Linearity: Use a kit to detect diluted samples according to 1 / 2, 1 / 4, 1 / 8, 1 / 16, 1 / 40, 1 / 80, 1 / 200, 1 / 400 of a high-value serum , make a regression curve with ...
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