CRP latex enhanced kit and preparation method and application thereof

A latex-enhanced and kit-based technology, applied in the field of medical products, can solve the problems of unfavorable product expansion, reduced sensitivity, accuracy, and high loss of raw materials, so as to meet the requirements of immune transmission and scattering detection, improve detection range and sensitivity, and simplify preparation. The effect of craftsmanship

Pending Publication Date: 2021-11-19
广西康柏莱科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, in the preparation process of R2 in CRP reagents, it takes a long time, low efficiency, and high loss of raw materials, which is not conducive to the expansion of product production and cannot achieve the purpose of mass production. During the production process, free EDC and antibodies need to be removed by centrifugation. , it is necessary to use ultrasonic method to disperse and resuspend the latex particles to improve the performance of the R2 reagent; otherwise, if the free EDC and antibody cannot be removed, the performance of the reagent R2 will be directly affected, the sensitivity and accuracy will be reduced, and the market demand cannot be met.

Method used

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  • CRP latex enhanced kit and preparation method and application thereof
  • CRP latex enhanced kit and preparation method and application thereof
  • CRP latex enhanced kit and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A CRP latex enhanced test kit comprising reagent R1 and reagent R2,

[0035] The reagent R1 contains ingredients at the following concentrations: 15.0 g / L of Na 2 HPO 4 12H 2 O, 1.2g of NaH 2 PO 4 2H 2 O, the Proclin 300 of the NaCl of the NaCl of 5.0g / L, the polyethylene glycol 6000 of 5.0g / L, 1g / L, the Proclin 300 of 1ml; The reagent R1 is prepared according to conventional methods;

[0036] The reagent R2 comprises the following concentrations of components: Tris-HCl buffer solution of 50mmol / L, 2-(N-morpholine)ethanesulfonic acid buffer solution of 50mmol / L, latex microspheres (80nm) of 2g / L, 1g / L latex microspheres (240nm), 0.15g / L EDC, 0.08g / L C-reactive protein antibody 1, 0.05g / L C-reactive protein antibody 2, 40g / L trehalose, 2.5g / L L bovine serum albumin;

[0037]The preparation method of the reagent R2 per two liters: the stirring speed is 200rpm;

[0038] (1) Activation: Take two containers A and B, add 500ml of 2-(N-morpholine) ethanesulfonic acid b...

Embodiment 2

[0075] A CRP latex enhanced test kit comprising reagent R1 and reagent R2,

[0076] The reagent R1 contains ingredients at the following concentrations: 20.0 g / L of Na 2 HPO 4 12H 2 O, 4.8g / L NaH 2 PO 4 2H 2 The NaCl of 0,20.0g / L, the Proclin300 of the Polyethylene Glycol 6000 of 15.0g / L, the Tween 20 of 5g / L, 1ml; Described reagent R1 is prepared according to conventional method;

[0077] The reagent R2 comprises the following concentrations of ingredients: 5mmol / L Heppes buffer, 5mmol / L 2-(N-morpholine)ethanesulfonic acid buffer, 1g / L latex microspheres (80nm), 0.5g / L latex microspheres (240nm), 0.08g / L EDC, 0.03g / L C-reactive protein antibody 1, 0.05g / L C-reactive protein antibody 2, 15g / L trehalose, 1.5g / L bovine serum albumin;

[0078] The preparation method of the reagent R2 per two liters: the stirring speed is 200rpm;

[0079] (1) Activation: Take two containers A and B, add 500ml of 2-(N-morpholine) ethanesulfonic acid buffer, A container adds latex microsphe...

Embodiment 3

[0084] A CRP latex enhanced test kit comprising reagent R1 and reagent R2,

[0085] The reagent R1 contains ingredients at the following concentrations: 16.0 g / L of Na 2 HPO 4 12H 2 O, 3.2g / L NaH 2 PO 4 2H 2 O, the Proclin300 of the NaCl of the NaCl of 15.0g / L, the polyethylene glycol 6000 of 8.0g / L, 3g / L, the Proclin300 of 1ml; The reagent R1 is prepared according to conventional methods;

[0086] Include the composition of following concentration in the described reagent R2: the PBS damping fluid of 25mmol / L, the glycine buffering fluid of 25mmol / L, the latex microsphere (80nm) of 1.2g / L, the latex microsphere (240nm) of 0.7g / L , 0.25g / L of EDC, 0.08g / L of C-reactive protein antibody 1, 0.08g / L of C-reactive protein antibody 2, 20g / L of sucrose, and 3g / L of bovine serum albumin;

[0087] The preparation method of the reagent R2 per two liters: the stirring speed is 200rpm;

[0088] (1) Activation: Take two containers A and B, add 500ml of glycine buffer, add latex mic...

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Abstract

The invention discloses a CRP latex enhanced kit and a preparation method and application thereof, which belong to the technical field of medical products. The CRP latex enhanced kit comprises a reagent R1 and a reagent R2, and the reagent R2 comprises the following components: a buffer solution 1, a buffer solution 2, latex microspheres 1, latex microspheres 2, EDC, a C-reactive protein antibody 1, a C-reactive protein antibody 2, a stabilizer and a sealing agent. The uniformly dispersed reagent R2 is obtained by controlling the feeding amount and simplifying the preparation process, the sensitivity of the obtained kit can achieve 0.15 mg / L, the CRP content at the high concentration level can be accurately determined, and the kit can be used for diagnosing various infectious diseases, inflammation diseases and other diseases.

Description

technical field [0001] The invention belongs to the field of medical products and technologies, and in particular relates to a CRP latex-enhanced kit and its preparation method and application. Background technique [0002] C-reactive protein (C-reactive protein, CRP) is synthesized by hepatocytes, produced during fetal life, and transmitted by non-maternal placenta. When the body is infected or the tissue is damaged, macrophages and other white blood cells are activated to produce interleukin-6, interleukin-1, tumor necrosis factor (TNF-a) and other cytokines and other mediators, these cells Factors and mediators reach the liver and stimulate hepatocytes and epithelial cells to synthesize CRP. [0003] C-reactive protein can be divided into ordinary CRP, ultra-sensitive CRP and full-scale CRP due to different detection sensitivity performance. Ordinary CRP is mainly used clinically to evaluate infection, tissue damage and inflammatory diseases, and at the same time provid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/546G01N33/543
CPCG01N33/6893G01N33/54346G01N33/54393G01N2333/4737G01N2800/7095G01N2800/26
Inventor 李名星刘利民张设熙韦佳志黄多全韦松利
Owner 广西康柏莱科技有限公司
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