Immunogenic polysaccharide vaccine and identification method thereof

Abstract

The invention relates to an immunogenic polysaccharide, an identification method, a polysaccharide vaccine prepared by using the immunogenic polysaccharide, and an identification method of the vaccine. Every identification method at least comprises the following steps: a polysaccharide antigen is in contact with a corresponding antibody to form an antigen-antibody complex, and the reaction rate ofthe generation of the antigen-antibody complex is detected by the rate scattering immunoturbidimetric assay technology. The rate scattering immunoturbidimetric assay technology is a technical way established based on an immunochemical technology, can be used to measure the intensity change of scattered lights caused by particles suspended in a small cup, and allows the reaction rate value to beobtained in several tens of seconds. The reaction of the antigen and the antibody is carried out to form antigen-antibody complex aggregate particles, and the particle formation rate differs dependingon the concentration of the antigen or the antibody. The methods have the advantages of high specificity, high sensitivity, saving of the detection time, and facilitation of the detection of a low-concentration sample by direct contact of the antigen and the antibody, and can be used for identifying a stock solution and / or a semi-finished product and / or a finished product in the vaccine production process.

Description

technical field [0001] The invention relates to the medical field, in particular to vaccines and vaccine identification, in particular to an immunogenic polysaccharide and its identification method, and an immunogenic polysaccharide vaccine and its identification method. Background technique [0002] The polysaccharide substances present in bacteria play an important role in bacterial recognition, signal transmission, adhesion, infection and defense. By extracting and purifying polysaccharide antigens that cause specific protective effects in bacteria, specific polysaccharide vaccines can be produced. Inoculation of polysaccharide vaccines can prevent infection of various diseases. It is especially important to control the quality of polysaccharide vaccines. Only after the vaccines are identified correctly and the components are correct, it is necessary to carry out analysis work such as inspection and content determination. Especially when there are multiple antigens in the...

AI Technical Summary

Problems solved by technology

In this method, the concentration of antigen and antibody should not be too small. The dilution of the free diffusion process will cause the concentration to be too small to produce a precipitation line, and the sample molecular weight is too large to be conducive to diffusion and affect the test effect.

[0005] In the specific operation, the immunological double diffusion method needs to prepare the gel plate in advance, dilute the antigen and antibody to the appropriate concentration, add them to the corresponding wells respectively, diffuse horizontally at 37°C for 24 hours, soak for 30 minutes, stain for 30 minutes, and then decolorize to the background. Color, observation, the whole process takes about 2 days or even longer, and the way of free diffusion is used to contact the antigen and antibody. The molecular weight of the sample should not be too large, and the concentration should not be too low, otherwise it will be difficult to form a clear precipitation line, especially for For samples whose antigenicity is reduced due to a series of reactions in the preparation process, it is more difficult to achieve the appropriate antigen concentration required in the immunodiffusion method, which makes it difficult to implement the identification test

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