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Latex turbidimetry freeze-drying reagent and preparation method thereof

A technology of latex and reagents, applied in the field of latex turbidimetric freeze-dried reagents and its preparation, can solve the problems that need to be strengthened, and achieve the effects of good protection effect, good coupling effect and outstanding stability

Active Publication Date: 2017-10-17
深圳优迪生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Therefore, research on latex turbidimetric reagents that can be stored at room temperature still needs to be strengthened.

Method used

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  • Latex turbidimetry freeze-drying reagent and preparation method thereof
  • Latex turbidimetry freeze-drying reagent and preparation method thereof
  • Latex turbidimetry freeze-drying reagent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] refer to figure 1 , according to the method for preparing latex turbidimetric freeze-dried reagent of the present invention, prepare latex CRP freeze-dried reagent, specifically as follows:

[0036] 1. Latex reagent preparation: take 100ml of latex solution with a particle size of 300nm and a concentration of 0.1‰, and 100ml of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride with a concentration of 0.5‰ (EDC) mixed, stirred gently at room temperature for 2 hours, in order to pre-activate the latex particles; then add 5ml of CRP (enhanced C-reactive protein) monoclonal antibody with a concentration of 0.1g / L, and incubate at 37°C for 4 hours; Add 0.21 g of bovine serum albumin (BSA), 0.21 g of vitamin C (Vc) and 0.042 g of glycine, stir to dissolve completely, and obtain the CRP latex reagent.

[0037] 2. Carry out cryogenic vacuum freeze-drying of the latex reagent: divide the CRP latex reagent into 2ml bottles, then put it into a vacuum freeze-dryer (Jiang...

Embodiment 2

[0040] refer to figure 1 , according to the method for preparing latex turbidimetric freeze-dried reagent of the present invention, prepare latex CRP freeze-dried reagent, specifically as follows:

[0041] 1. Latex reagent preparation: take 100ml of latex solution with a particle size of 200nm and a concentration of 1‰, and 500ml of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride with a concentration of 0.1‰ (EDC) mixed, stirred gently at room temperature for 2 hours, in order to pre-activate the latex particles; then add 100ml of CRP monoclonal antibody with a concentration of 0.1g / L, and incubate for 4 hours at 37°C; add 3.5g of BSA, 7.0 gVc and 1.4g glycine were stirred to dissolve completely to obtain CRP latex reagent.

[0042] 2. Carry out cryogenic vacuum freeze-drying of the latex reagent: divide the CRP latex reagent into 2ml bottles, then put it into a vacuum freeze-dryer (Jiangyin Science and Technology Co., Ltd., model GD-2) to start the vacuum pump, a...

Embodiment 3

[0045] refer to figure 1 , according to the method for preparing latex turbidimetric freeze-dried reagent of the present invention, prepare latex CRP freeze-dried reagent, specifically as follows:

[0046] 1. Latex reagent preparation: Take 100ml of latex solution with a particle size of 200nm and a concentration of 0.5‰, and 250ml of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride with a concentration of 0.3‰ (EDC) mixed, stirred gently at room temperature for 2 hours, in order to pre-activate the latex particles; then add 20ml of CRP monoclonal antibody with a concentration of 0.1g / L, and incubate at 37°C for 4 hours; then add 1.0g of BSA, 3.0 gVc and 0.5g glycine were stirred to dissolve completely to obtain CRP latex reagent.

[0047] 2. Carry out cryogenic vacuum freeze-drying of the latex reagent: divide the CRP latex reagent into 2ml bottles, then put it into a vacuum freeze-dryer (Jiangyin Science and Technology Co., Ltd., model GD-2) to start the vacuum p...

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Abstract

The invention discloses a latex turbidimetry freeze-drying reagent and a preparation method thereof. The method comprises the following steps: coupling latex particles and monoclonal antibodies, and then adding a protective agent, so as to obtain a latex antibody reagent, and ensuring that the protective agent comprises bovine serum albumin, vitamin C and glycine; performing low-temperature vacuum freeze drying on the latex antibody reagent, so as to obtain a lyophilized product, and ensuring that low-temperature vacuum freeze drying is realized through repeated freezing and thawing; sealing the lyophilized product in an inert gas atmosphere, so as to obtain the latex turbidimetry freeze-drying reagent. The latex turbidimetry freeze-drying reagent prepared through the method is good in stability, fast to redissolve and good in uniformity, without suspended solids; after the latex turbidimetry freeze-drying reagent is redissolved, the performance of the latex turbidimetry freeze-drying reagent is not affected, the latex turbidimetry freeze-drying reagent is rapid in reaction with a whole blood sample, a result can be reported within 1 minute, the repeatability is very good, and the result is accurate and reliable.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic reagents, in particular to a latex turbidimetric freeze-dried reagent and a preparation method thereof. Background technique [0002] In vitro diagnostic reagents are those that can be used alone or in combination with instruments, appliances, equipment or systems, and are used to test human samples in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and prediction of genetic diseases. (Various body fluids, cells, tissue samples, etc.) Reagents, kits, calibrator (items), quality control items (items), etc. for in vitro testing. As a type of medical device, in vitro diagnostic reagents are different from instruments and equipment in that the reagents have an expiration date, that is, the period during which the performance of the reagents can be stably maintained under the declared storage conditions. The validity perio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/82G01N33/68G01N33/577G01N33/543G01N33/531
CPCG01N33/531G01N33/54313G01N33/577G01N33/68G01N33/82
Inventor 艾峰刘丹刘彪
Owner 深圳优迪生物技术有限公司
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