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Heat stabilizer for antigen-antibody reaction in-vitro diagnostic reagent

A diagnostic reagent, antigen-antibody technology, applied in the field of in vitro diagnosis, can solve the problems of decreased reaction sensitivity, reagent failure, structural curling or allosteric, etc., and achieves the effect of improving thermal stability and prolonging storage time.

Inactive Publication Date: 2015-07-29
JUSBIO SCI SHANGHAI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patents CN200610025351, CN101893619A, etc. mentioned methods for improving the stability of latex-bound antigen or antibody particles only evaluate the stability from 4-degree storage conditions; in vitro diagnostic reagents for antigen-antibody reactions include not only reagents for latex-enhanced particle methods, but also Including ordinary immunoturbidimetric reagents, the common characteristics of these reagents are that antigen or antibody will slowly precipitate, structure curl or change structure in solution at low temperature such as 2-8 degrees, resulting in distortion of antigen-antibody reaction and affecting the determination
Especially in the environment above 10 degrees or the environment of the solution is not good (for example, the pH of the buffer in the latex reagent is not suitable, causing the antibody to fall off, the concentration of BSA is too high, the concentration of the surfactant is too high, etc. to replace the cross-linked antibody), the antigen or The Brownian motion of the antibody in the solution is strengthened, which will lead to a sharp drop in reaction sensitivity, which is irreversible, making the reagent invalid
In addition, the kit cannot be completely guaranteed to be carried out in a 4-degree environment during use and actual transportation.

Method used

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  • Heat stabilizer for antigen-antibody reaction in-vitro diagnostic reagent
  • Heat stabilizer for antigen-antibody reaction in-vitro diagnostic reagent
  • Heat stabilizer for antigen-antibody reaction in-vitro diagnostic reagent

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Experimental program
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Embodiment

[0018] A heat stabilizer for antigen-antibody reaction in vitro diagnostic reagents, comprising surfactants, blocking agents, preservatives, buffers, stabilizers and inorganic salts. The surfactant is Emulgen B66, the blocking agent is polylysine, the preservative is PC300, and the buffer is MES buffer, which is produced by AMRESCO. The pH is 6.0 (25° C.), the stabilizer is sucrose, and the inorganic salt is sodium chloride.

[0019] Prepare cystatin C assay reagent, lipoprotein (a) assay reagent, β2-microglobulin assay reagent and prealbumin assay reagent according to routine method, each reagent is composed as follows:

[0020] Cystatin C assay reagent composition:

[0021] R1:

[0022] Tris: 50mmol / L

[0023] Sodium chloride: 50mmol / L

[0024] PEG2000: 5g / L

[0025] R2:

[0026] Glycine: 10mmol / L

[0027] Goat anti-cystatin C antibody sensitized latex: 10ml / L

[0028] Lipoprotein(a) Determination Reagent Composition

[0029] R1:

[0030] Tris: 50mmol / L

[0031] S...

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Abstract

The invention provides a heat stabilizer for an antigen-antibody reaction in-vitro diagnostic reagent. The heat stabilizer is characterized by comprising a surfactant, a sealant, a preservative, a buffer solution, a stabilizer and inorganic salt. The heat stabilizer can be used for effectively improving the thermal stability of the antigen-antibody reaction in-vitro diagnostic reagent and effectively prolonging the retention time of a kit.

Description

technical field [0001] The invention relates to the field of in vitro diagnosis or the field of biotechnology, and is used for improving the thermal stability of antigen-antibody reaction in vitro diagnostic reagents. Background technique [0002] Immunoassay is a commonly used diagnostic method in the field of medical health and biological science research. The core step of immunoassay is the specific compound reaction between antigen and antibody, and the detection signal is generated through the compound reaction to realize the quantification of the antibody or antigenicity in the solution. Because antibody molecules can recognize a very limited number of molecular species, immunoassays can achieve extremely high accuracy. [0003] The current reports on the stability of in vitro diagnostic reagents for antigen-antibody reactions are all based on the long-term stability under storage conditions of 2-10 degrees to evaluate the stability. Patents CN200610025351, CN1018936...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53
CPCG01N33/5306
Inventor 孙先胜
Owner JUSBIO SCI SHANGHAI CO LTD
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