Determination kit based on latex immunoturbidimetry and application of determination kit

Abstract

The invention discloses a determination kit based on latex immunoturbidimetry and application of the determination kit, and belongs to the technical field of immunoassay medicine. The kit is composedof a reagent R1 and a reagent R2, the R2 reagent contains a latex reagent coupled with an antibody, the latex reagent is composed of a small-particle-size latex reagent and a large-particle-size latexreagent, wherein, in the small-particle-size latex reagent, the mass ratio of small-particle-size latex microspheres to an activating agent to the antibody is 1: 0.08-0.12: 0.04-0.06, and in the preparation process of the large-particle-size latex reagent, the mass ratio of the large-particle-size latex microspheres to the activating agent to the antibody is 1: (0.02-0.04): (0.005-0.01). For latex microspheres with different particle sizes, the optimal use amounts of the activator and the antibody are respectively selected so as to maximally provide the effects of the latex microspheres withdifferent particle sizes, such that the functional sensitivity and the linearity of the finally prepared kit are significantly improved so as to completely meet different clinical requirements while other performances of the kit are not affected.

Description

technical field [0001] The invention belongs to the technical field of immunoanalysis medicine, and in particular relates to a latex immunoturbidimetric-based assay kit and an application thereof. Background technique [0002] Immunoturbidimetry is a dynamic assay method for antigen-antibody binding. Its basic principle is: when the antigen and antibody react in a special dilution system and the ratio is appropriate, the formed soluble immune complex is precipitated from the liquid phase under the action of a polymerization accelerator. , the formation of particles, so that the reaction solution appears turbidity. When the antibody concentration is fixed, the amount of the formed immune complex increases with the increase of the amount of antigen in the test sample, and the turbidity of the reaction solution also increases accordingly. By measuring the turbidity of the reaction solution and comparing it with a series of standard substances, the antigen content in the test s...

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Problems solved by technology

[0004] Based on the above requirements, latex microspheres with large particle size and latex microspheres with small particle size are mixed in the market, and the average diameter and concentration of large and small particles are optimized to achieve the purpose of improving reagent sensitivity and linearity at the same time, such as Chinese patent CN110133247A Disclosed is an immunolatex turbidimetric assay kit for detecting the target antigen. The reagent is prepared by mixing two microspheres with an average particle diameter difference of more than 50nm according to a certain ratio to improve the sensitivity and linear width of the kit. However, the The preparation process of the large and small nanospheres in the patent is the same, that is, the content of the activator and antibody added to the large and small nanospheres is the same, but the microspheres with different particle sizes require the content of the activator and the amount of antibody that can be combined. The amount of antibody is different, and the amount of activator and antibody in the system is insufficient or excessive, which will negatively affect the sensitivity and linear width of the reagent

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