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Reagent prepared based on radiation technology and preparation method thereof

A technology of reagents and technologies, applied in the field of reagent preparation, can solve the problems of difficult control of coupling effect, influence of reagent stability, complicated operation process, etc.

Pending Publication Date: 2020-10-20
JILIN GETEIN BIOTECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The disadvantage of this method is: the operation process is complicated, the addition of the activator and the antibody has a certain time interval, and must be carried out sequentially and can be added under stirring conditions
The activation effect under this operation process is related to various factors such as activator concentration, activation time, and activation temperature. The coupling effect is not easy to control, and the latex reagent after coupling is prone to self-coagulation reaction, which affects the stability of the reagent.

Method used

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  • Reagent prepared based on radiation technology and preparation method thereof
  • Reagent prepared based on radiation technology and preparation method thereof
  • Reagent prepared based on radiation technology and preparation method thereof

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preparation example Construction

[0029] The present invention at first provides a kind of preparation method based on the reagent prepared by radiation technology, this method comprises:

[0030] Step 1: Mix the latex particles and the buffer to obtain a latex particle solution; the latex particles are preferably JSR brand P0001-P2118, the particle size range is 50nm-200nm, and the functional group that binds to the antibody is a carboxyl group; the described The buffer is one of phosphate buffer, carbonate buffer, borate buffer and MES buffer with a pH between 5-10 and a concentration of 25-200mM / L;

[0031] Step 2: Seal the latex particle solution in step 1, and use cobalt-60 ray or electron accelerator ray to irradiate. The radiation energy range is preferably 0.5KGY-50KGY, and the radiation time is preferably 1-20min to obtain radiation treatment. latex particles;

[0032] Step 3: Add the target antibody to the treated latex particles in step 2, stir until uniform, and obtain a mixture; the target antibo...

Embodiment 1

[0040] Taking the preparation of full-scale CRP (latex immunoturbidimetric method) as an example, the reagent preparation steps are as follows:

[0041] R1 preparation:

[0042] The order of adding materials is 4.35g / L PIPES, 10.64g / L PIPES-2Na, 9g / L sodium chloride, 10g / L PEG6000, 0.5g / L sodium azide and 0.5g / L BAS, stirring and dissolving, That is, the R1 reagent is obtained;

[0043] R2 preparation: anti-human CRP antibody latex particle solution

[0044] ① Dilute 20mL of polystyrene latex microspheres (JSR brand P0001-P2118) with a particle size of 120nm to 100mL with pH 6.5 50mM / LTristan buffer and mix well to obtain a latex microsphere solution;

[0045]②Activation: seal the latex microsphere solution, and activate it by cobalt 60 ray 5KGY radiation for 10 minutes to obtain activated latex microspheres;

[0046] ③ Coupling: Add 20 mg of anti-human CRP antibody to the activated latex microsphere (100 mg) solution, stir well, and then irradiate the mixed solution with c...

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Abstract

The invention provides a reagent prepared based on a radiation technology and a preparation method thereof, which belong to the technical field of reagent preparation. The method comprises the steps of activating latex microspheres and a buffer solution under radiation energy; fully mixing the latex microspheres with an antibody; coupling the latex microspheres with the antibody under a radiationcondition; adding a confining liquid; and removing the unbound antibody and blocking protein to obtain the target reagent. The method for preparing the latex in-vitro diagnostic reagent is simple, good in reagent stability, high in coupling efficiency and more suitable for batch production.

Description

technical field [0001] The invention belongs to the technical field of reagent preparation, and in particular relates to a reagent prepared based on radiation technology and a preparation method thereof. Background technique [0002] In vitro diagnostic reagents are reagents, kits, calibrators, and quality controls used for in vitro testing of human samples in the process of disease prevention, diagnosis, treatment testing, prognosis observation, health status evaluation, and prediction of genetic diseases. Among them, biochemical, immunological and molecular diagnostic reagents are the three major categories of diagnostic reagents in my country. [0003] Immunodiagnostic reagents are reagents that are determined through the specific binding reaction of antigens and antibodies, and are generally divided into immunoturbidimetric methods and latex-enhanced immunoturbidimetric methods. Latex-enhanced immune turbidimetry is an improvement on the basis of immune turbidimetry, th...

Claims

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Application Information

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IPC IPC(8): G01N33/531G01N33/543
CPCG01N33/531G01N33/54313Y02A50/30
Inventor 刘艳艳刘玲徐李鹏
Owner JILIN GETEIN BIOTECH CO LTD
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