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A kit for rapidly and accurately detecting novel coronavirus igm antibody and preparation method thereof

A coronavirus and kit technology, applied in the field of rapid and accurate detection of new coronavirus IgM antibodies, can solve the problems of high detection environment and false negative results in nucleic acid detection, and achieve the effect of improving sensitivity and detection rate

Active Publication Date: 2021-02-05
BEIJING BEIER BIOENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in clinical practice, nucleic acid testing may be affected by factors such as sample collection site, collection method, and course of disease, resulting in false negative results.
Moreover, due to the high requirements on the testing environment and personnel for nucleic acid testing, it also brings great challenges to the CDC and hospitals.

Method used

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  • A kit for rapidly and accurately detecting novel coronavirus igm antibody and preparation method thereof
  • A kit for rapidly and accurately detecting novel coronavirus igm antibody and preparation method thereof
  • A kit for rapidly and accurately detecting novel coronavirus igm antibody and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] 1. A test kit for rapidly and accurately detecting novel coronavirus IgM antibodies, said test kit comprising:

[0065] Luminescent substrate solution A, luminescent substrate solution B, sample diluent, enzyme label working solution, calibrator and magnetic bead suspension;

[0066] Wherein the luminescent substrate solution A comprises the following final concentrations of components:

[0067] Tris 0.02g / L, hydrochloric acid 0.006ml / L, luminol 0.003g / L;

[0068] Luminescent substrate solution B includes the following final concentrations of components:

[0069]Sodium dihydrogen phosphate 0.2g / L, disodium hydrogen phosphate 2.9g / L, carbamide peroxide 0.01g / L, sodium chloride 9g / L;

[0070] Sample diluents consisted of components at the following final concentrations:

[0071] BSA 10g / L, sodium chloride 9g / L, ProCLin300 0.5ml / L;

[0072] The enzyme-labeled working solution includes the following final concentrations of components:

[0073] Horseradish peroxidase-la...

Embodiment 2

[0081] 1. A fast and accurate test kit for detecting novel coronavirus IgM antibody, the components of the kit are the same as in Example 1, the difference is only that the magnetic bead suspension is a magnetic particle coupled with mouse anti-human IgM antibody 2;

[0082] Among them, the mouse anti-human IgM antibody 2 was purchased from Hangzhou Longji Biotechnology Co., Ltd., the product number is MS00704, and the batch number is M19111501.

[0083] 2. Refer to Example 1 for the preparation method of the above kit.

Embodiment 3

[0085] 1. A fast and accurate test kit for detecting novel coronavirus IgM antibodies, the components of the kit are the same as those in Example 1, the only difference being that the magnetic bead suspension is magnetic particles coupled with mouse anti-human IgM antibody 3;

[0086] Among them, the mouse anti-human IgM antibody 3 was purchased from Hefei Kangruixiang Biotechnology Co., Ltd., the product number is XY080, and the batch number is 20190906.

[0087] 2. Refer to Example 1 for the preparation method of the above kit.

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Abstract

The embodiment of the present invention relates to clinical in vitro detection, in particular to a kit for rapidly and accurately detecting novel coronavirus IgM antibody and a preparation method thereof. The kit provided by the present invention includes: horseradish peroxidase-labeled novel coronavirus antigen; and, magnetic particles coupled with anti-human IgM antibody; the novel coronavirus antigen comprises N protein derived from novel coronavirus N Protein antigen and S protein antigen derived from the novel coronavirus S protein. The kit provided by the invention uses the IgM antibody of the new coronavirus as the detection object, which is helpful for early auxiliary diagnosis of patients; it uses N protein and S protein fragments together as antigens, which can improve specificity without affecting specificity. The sensitivity of related products can complement nucleic acid detection to increase the detection rate of new coronary pneumonia; and its positive detection rate is significantly higher than that of similar new coronavirus IgM detection products on the market, which can more accurately serve the field of in vitro diagnosis.

Description

technical field [0001] The invention relates to clinical in vitro detection, in particular to a kit for rapidly and accurately detecting novel coronavirus IgM antibodies and a preparation method thereof. Background technique [0002] 2019 Novel Coronavirus (2019Novel Coronavirus, 2019-nCoV) causes Novel Coronavirus Pneumonia (COVID-19). Nucleic acid testing is recommended as the main diagnostic method for COVID-19. However, in clinical practice, nucleic acid testing may be affected by factors such as sample collection site, collection method, and course of disease, resulting in false negative results. Moreover, due to the high requirements for the testing environment and personnel, nucleic acid testing also brings great challenges to the CDC and hospitals. Therefore, it is of great significance to establish a fast, accurate, simple, safe and effective detection method for the new coronavirus. [0003] 2019-nCoV belongs to the genus Betacoronavirus, and its genome is a pos...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/68G01N33/569G01N33/543G01N33/535
CPCG01N33/535G01N33/54326G01N33/56983G01N33/6854G01N2469/20
Inventor 王玲
Owner BEIJING BEIER BIOENG
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