SARS-CoV-2 neutralizing antibody detection kit

Abstract

The invention relates to an SARS-CoV-2 neutralizing antibody detection kit. The SARS-CoV-2 neutralizing antibody detection kit comprises a solid phase carrier, a first antigen and a second antigen ofS protein of SARS-CoV-2, and the second antigen is marked with a signal substance. Whether a tested person is infected by the new coronavirus or not and whether infection risks exist or not are judgedby detecting a neutralizing antibody through an immunodiagnosis technology, and the method is reliable in theory, practical and feasible and can be completed only in a secondary biosafety laboratory.

Description

technical field

[0001] The invention relates to the field of biomedical detection, in particular to a SARS-CoV-2 neutralizing antibody detection kit. Background technique

[0002] Coronaviridae is divided into 4 genera α, β, γ and δ, and the α and β genera coronaviruses can infect mammals and humans. Severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coro-navirus 2, SARS-CoV-2) is a new type of coronavirus belonging to the genus β, round or oval, with a diameter of 60-140nm, and a crown-like shape under an electron microscope. Similar to SARS-CoV that emerged in 2002, SARS-CoV-2 belongs to the subgenus Sarbecovirus (Coronaviridae, Coronaviridae), and both rely on the ACE2 protein on the surface of human cells as a cell entry receptor. Protein sequence analysis found that the amino acid similarity between SARS-CoV-2 and SARS-CoV was 94.6% in seven conserved non-structural proteins.

[0003] The existing detection methods for SARS-CoV-2 mainly...

Examples

Embodiment 1

[0057] The invention provides a novel coronavirus neutralizing antibody magnetic particle chemiluminescence detection kit and a preparation method, the specific steps are as follows:

[0058] 1) The novel coronavirus S protein antigen labeled with magnetic particles, including the preparation of magnetic particle preservation solution;

[0059] 2) The novel coronavirus S protein antigen labeled with acridinium ester, including the preparation of diluent;

[0060] 3) Preparation of novel coronavirus neutralizing antibody calibrator 1;

[0061] 4) Preparation of novel coronavirus neutralizing antibody calibrator 2.

[0062] Other materials that may be needed: Substrate A solution for automatic immunoassay system, Substrate B solution for automatic immunoassay system, cleaning solution, cuvette, purified water required for the experiment process.

[0063] The preparation of the magnetic particle preservation solution in the step 1) comprises the following steps:

[0064] 1.1 W...

Embodiment 2

[0097] A preparation method of a novel coronavirus neutralizing antibody rapid diagnostic kit, the cartridge of the kit contains a novel coronavirus neutralizing antibody detection test strip, and the test strip is composed of a sample pad, a gold standard pad, a reaction membrane and the water-absorbing layer are pasted on it in turn, the test strip is made of glass fiber as the sample pad, the absorbent paper is used as the water-absorbing layer, and the paper card with adhesion is used as the backing card; the gold standard pad is a new type of coronavirus antigen labeled with colloidal gold. Loaded on a glass fiber mat, the reaction membrane is made by coating a new coronavirus S protein antigen on a nitrocellulose membrane to make a detection line, and at the same time coated with a mouse anti-IgG antibody to make a quality control line. The specific preparation method includes the following steps :

[0098] 1. Preparation of Gold Label Pads

[0099] It is to load the co...

technical field

[0001] The invention relates to the field of biomedical detection, in particular to a SARS-CoV-2 neutralizing antibody detection kit. Background technique

[0002] Coronaviridae is divided into 4 genera α, β, γ and δ, and the α and β genera coronaviruses can infect mammals and humans. Severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coro-navirus 2, SARS-CoV-2) is a new type of coronavirus belonging to the genus β, round or oval, with a diameter of 60-140nm, and a crown-like shape under an electron microscope. Similar to SARS-CoV that emerged in 2002, SARS-CoV-2 belongs to the subgenus Sarbecovirus (Coronaviridae, Coronaviridae), and both rely on the ACE2 protein on the surface of human cells as a cell entry receptor. Protein sequence analysis found that the amino acid similarity between SARS-CoV-2 and SARS-CoV was 94.6% in seven conserved non-structural proteins.

[0003] The existing detection methods for SARS-CoV-2 mainly...

Examples

Embodiment 1

[0057] The invention provides a novel coronavirus neutralizing antibody magnetic particle chemiluminescence detection kit and a preparation method, the specific steps are as follows:

[0058] 1) The novel coronavirus S protein antigen labeled with magnetic particles, including the preparation of magnetic particle preservation solution;

[0059] 2) The novel coronavirus S protein antigen labeled with acridinium ester, including the preparation of diluent;

[0060] 3) Preparation of novel coronavirus neutralizing antibody calibrator 1;

[0061] 4) Preparation of novel coronavirus neutralizing antibody calibrator 2.

[0062] Other materials that may be needed: Substrate A solution for automatic immunoassay system, Substrate B solution for automatic immunoassay system, cleaning solution, cuvette, purified water required for the experiment process.

[0063] The preparation of the magnetic particle preservation solution in the step 1) comprises the following steps:

[0064] 1.1 W...

Embodiment 2

[0097] A preparation method of a novel coronavirus neutralizing antibody rapid diagnostic kit, the cartridge of the kit contains a novel coronavirus neutralizing antibody detection test strip, and the test strip is composed of a sample pad, a gold standard pad, a reaction membrane and the water-absorbing layer are pasted on it in turn, the test strip is made of glass fiber as the sample pad, the absorbent paper is used as the water-absorbing layer, and the paper card with adhesion is used as the backing card; the gold standard pad is a new type of coronavirus antigen labeled with colloidal gold. Loaded on a glass fiber mat, the reaction membrane is made by coating a new coronavirus S protein antigen on a nitrocellulose membrane to make a detection line, and at the same time coated with a mouse anti-IgG antibody to make a quality control line. The specific preparation method includes the following steps :

[0098] 1. Preparation of Gold Label Pads

[0099] It is to load the co...