C-reactive protein kit suitable for various POCT instruments

A reactive protein and kit technology, applied in the biological field, can solve the problems of poor reagent compatibility, low coupling efficiency, and long coupling time, and achieve the effects of improving poor compatibility, simplifying cross-linking steps, and shortening the cross-linking method

Pending Publication Date: 2020-11-06
SHANGHAI JIEMEN BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the existing method of preparing carboxyl microspheres using activators, there are many problems, such as the need for centrifugation to remove free activators and free unbound antibodies after the antibody is coupled to the microspheres, making the operation process difficult. Inefficient and time-consuming, it is not conducive to the industrial preparation of carboxyl microspheres; it is necessary to activate the microspheres with a cross-linking agent for a period of time, and then add additional solution to adjust the pH value before the cross-linking reaction can proceed, thus prolonging the preparation time of the reaction , Increased the complexity of the operation; the requirements for the pH value are strict, and there are high requirements for the solution and the microspheres. At this time, the coupling efficiency is low, which limits the operability of cross-linking to a certain extent; in addition , the coupling effect obtained by the existing preparation method is often limited to a certain similar instrument, and at least two steps of centrifugation or multi-step microsphere and antibody treatment are required, and the application range of the latex reagent is narrow, which is not suitable for a variety of products currently on the market. Various POCT instruments
Therefore, in summary, the biggest problems of the cross-linking methods commonly used in the prior art are long coupling time, poor reagent compatibility and strict requirements on cross-linking conditions.

Method used

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  • C-reactive protein kit suitable for various POCT instruments
  • C-reactive protein kit suitable for various POCT instruments
  • C-reactive protein kit suitable for various POCT instruments

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] The kit of the present invention is a liquid double reagent, that is, reagent R1 and reagent R2; wherein, the volume ratio of reagent R1 to R2 is 10:1. specific,

[0085] Reagent R1 formula is as follows:

[0086]

[0087]

[0088] The pH is 7.1.

[0089] Reagent R2 contains the following components:

[0090]

[0091] The pH value is 7.1.

[0092] Preparation of reagents:

[0093] 1. The preparation of R1: Dissolve each component in purified water according to the content, mix well, and constant volume.

[0094] 2. The mixed C-reactive protein polyclonal antibody latex particles 1.25g / L were prepared by one-step method:

[0095] (1) the latex microspheres of 70nm and 300nm of 30ml are diluted to the microsphere solution of 5% 70nm and the microsphere solution of 300nm with 0.1mol / L MES damping fluid respectively to final reaction concentration;

[0096] (2) Prepare 5ml of 10g / L C-reactive polyclonal protein antibody and store it at room temperature for la...

Embodiment 2

[0115] The kit of the present invention is a liquid double reagent, that is, reagent R1 and reagent R2; wherein, the volume ratio of reagent R1 to R2 is 10:1. specific,

[0116] Reagent R1 formula is as follows:

[0117]

[0118] The pH is 7.1.

[0119] Reagent R2 contains the following components:

[0120]

[0121] The pH value is 7.1.

[0122] Preparation of reagents:

[0123] 1. The preparation of R1: Dissolve each component in purified water according to the content, mix well, and constant volume.

[0124] 2. Preparation of the mixed C-reactive protein polyclonal antibody latex particles 1.25g / L:

[0125] (1) the latex microspheres of 70nm and 300nm of 30ml are diluted to the microsphere solution of 5% 70nm and the microsphere solution of 300nm with 0.1mol / L MES damping fluid respectively to final reaction concentration;

[0126] (2) Prepare 5ml of 10g / L C-reactive protein polyclonal antibody and store it at room temperature for later use;

[0127] (3) After w...

Embodiment 3

[0139] The kit of the present invention is a liquid double reagent, that is, reagent R1 and reagent R2, wherein the ratio of reagent R1 to R2 is 10:1. specific,

[0140] Reagent R1 formula is as follows:

[0141]

[0142] The pH is 7.1.

[0143] Reagent R2 contains the following components:

[0144]

[0145] Preparation of reagents:

[0146] 1. The preparation of R1: Dissolve each component in purified water according to the content, mix well, and constant volume.

[0147] 2. Preparation of the mixed C-reactive protein polyclonal antibody latex particles 1.25g / L:

[0148] (1) the latex microspheres of 70nm and 300nm of 30ml are diluted to the microsphere solution of 5% 70nm and the microsphere solution of 300nm with 0.1mol / L MES damping fluid respectively to final reaction concentration;

[0149] (2) Prepare 5ml of 10g / L C-reactive protein polyclonal antibody and store it at room temperature for later use;

[0150] (3) After weighing 0.025g of EDC activator and ful...

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Abstract

The invention provides a C-reactive protein kit suitable for various POCT (point-of-care testing) instruments. The C-reactive protein kit comprises a reagent R1, a reagent R2 and a C-reactive proteincalibrator, wherein the reagent R1 comprises a buffer solution, an electrolyte, a protective agent, a thickener and a preservative; the reagent R2 comprises C-reactive protein polyclonal antibody latex particles, a buffer solution, a protective agent, an electrolyte, a precipitator and a preservative; the C-reactive protein calibrator comprises a C-reactive protein antigen, a buffer solution and aprotective agent. The C-reactive protein kit is high in sensitivity, good in stability, good in repeatability, capable of improving the production efficiency and shortening the reaction time and suitable for various POCT instruments.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a C-reactive protein kit suitable for various POCT instruments. Background technique [0002] C-reactive protein (CRP) is an acute phase response protein with very low concentrations in healthy people. Patients with invasive bacterial infection, inflammation or tissue damage will have increased serum CRP concentrations, and the increase in CRP can be detected 6-12 hours after the onset of inflammation, because its peak value increases faster than other inflammatory indicators , so it can be used as an early diagnostic indicator for diagnosing related diseases. [0003] There are also many methods for detecting CRP. Most of the current detection methods require the use of automatic biochemical analyzers or automatic immune analyzers. Although these instruments have accurate test results, their prices are often too high. With the development of the medical industry, the a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/543
CPCG01N33/68G01N33/54313G01N2333/4737
Inventor 张冉冉周伟毛晓波
Owner SHANGHAI JIEMEN BIO TECH
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