CN-122011179-A - Anti-mycobacterium tuberculosis MPT64 protein antibody or antigen binding fragment thereof and application thereof

Abstract

The invention relates to an antibody of anti-mycobacterium tuberculosis MPT64 protein or antigen binding fragment thereof in the technical field of immunological detection, which can specifically bind to the mycobacterium tuberculosis MPT64 protein, and comprises a heavy chain variable region and a light chain variable region, wherein the amino acid sequence of the heavy chain variable region is shown as SEQ ID NO. 2, and the amino acid sequence of the light chain variable region is shown as SEQ ID NO. 4. The antibody or the antigen binding fragment thereof is used as a key recognition molecule in an immune detection system, is used for immunological detection of MPT64 protein, and provides a basis for constructing a stable and reliable mycobacterium tuberculosis related immune detection method and detection reagent.

Inventors

• ZHOU HEFENG
• SHAO MIN
• LI HAI

Assignees

• 遵义医科大学珠海校区

Dates

Publication Date

20260512

Application Date

20260304

Claims (9)

1. 1. An antibody or antigen binding fragment thereof for resisting mycobacterium tuberculosis MPT64 protein is characterized in that the antibody can specifically bind mycobacterium tuberculosis MPT64 protein, the antibody comprises a heavy chain variable region and a light chain variable region, the amino acid sequence of the heavy chain variable region is shown as SEQ ID NO. 2, and the amino acid sequence of the light chain variable region is shown as SEQ ID NO. 4.
2. 2. The antibody or antigen-binding fragment thereof against the MPT64 protein of Mycobacterium tuberculosis according to claim 1, wherein the antibody is a monoclonal antibody.
3. 3. An antibody or antigen-binding fragment thereof against the MPT64 protein of Mycobacterium tuberculosis as described in claim 2, wherein the heavy chain subclass of the antibody is IgG1 and the light chain is kappa type.
4. 4. A nucleic acid molecule encoding the antibody of any one of claims 1 to 3, wherein the nucleic acid molecule comprises a nucleotide sequence encoding the heavy chain variable region as shown in SEQ ID NO.1 and a nucleotide sequence encoding the light chain variable region as shown in SEQ ID NO. 3.
5. 5. A recombinant expression vector comprising the nucleic acid molecule of claim 4.
6. 6. The recombinant expression vector of a nucleic acid molecule of claim 5, wherein said vector is a pET28a (+) expression vector.
7. 7. A host cell comprising the recombinant expression vector of claim 5 or 6.
8. 8. A cell line capable of producing the antibody according to any one of claims 1 to 3.
9. 9. Use of the antibody or antigen binding fragment thereof according to any one of claims 1-3 in the preparation of a reagent or kit for detecting mycobacterium tuberculosis MPT64 protein.

Description

Anti-mycobacterium tuberculosis MPT64 protein antibody or antigen binding fragment thereof and application thereof Technical Field The invention relates to the technical field of immunological detection, in particular to an antibody against mycobacterium tuberculosis MPT64 protein or an antigen binding fragment thereof and application thereof. Background Tuberculosis (TB) is a chronic infectious disease caused mainly by mycobacterium Tuberculosis (Mycobacterium Tuberculosis, MTB), which can involve multiple organs throughout the body, with Tuberculosis being the most common. At present, tuberculosis has become a single infectious disease with highest global mortality rate, and seriously threatens human health. China is one of the countries with high global tuberculosis burden, so that the development of a rapid, accurate and simple diagnosis technology has important significance for prevention, control and treatment of tuberculosis. The diagnosis technology of the mycobacterium tuberculosis mainly comprises a plurality of methods such as tuberculin test, bacteriological detection, molecular biological technology, immunological detection and the like. Tuberculin Skin Test (TST), while simple and rapid to operate, is not specific enough to distinguish between Mycobacterium tuberculosis infection, BCG vaccination response and nontuberculous mycobacterial (NTM) infection. In bacteriological detection, the acid-fast staining method can only identify mycobacterium species but cannot distinguish specific strains, the fluorescent staining method has the limitation of higher false positive rate, the traditional culture method has the problems of long culture period, lower positive rate and the like when being used as a diagnosis 'gold standard', and the instrument system culture method (such as BACTEC MGIT 960) also has the challenges of expensive equipment, radioactive pollution and the like. Molecular biology techniques such as GeneXpert, TB-LAMP and whole genome sequencing have good diagnostic value, but are limited by high equipment cost and professional technical requirements, and are limited in popularization and application. The gamma-interferon release assay (IGRA) recommended by the world health organization, while highly specific and unaffected by bcg vaccination, results in higher detection costs due to the need for specialized equipment. Since one of the earliest biomarkers generated after infection of the organism with mycobacterium tuberculosis is a tuberculosis specific antigen, antigen detection can be used as direct evidence of tuberculosis infection. The immunological detection method established based on antigen-antibody specific reaction has high specificity and sensitivity, and is simple, convenient, quick and efficient to operate, thus becoming an important auxiliary means in early diagnosis of tuberculosis. In recent years, immunological detection research on specific antigens of mycobacterium tuberculosis and corresponding antibodies thereof is receiving increasingly wide attention from students at home and abroad. Among the antigens related to the mycobacterium tuberculosis, MPT64 is one of immunogenic proteins secreted by a mycobacterium tuberculosis complex, has better antigen specificity, and is widely focused in the research and immunological detection of the mycobacterium tuberculosis. Detection strategies based on MPT64 antigen generally rely on the ability of antibodies to specifically recognize target antigens, the detection effect of which depends largely on the specificity, stability and batch-to-batch consistency of the antibodies employed. In the prior art, antibodies aiming at MPT64 still have differences in sources, preparation modes and immunological properties, and partial antibodies can have problems of non-specific binding or insufficient reaction consistency and the like in practical application, thereby influencing the reliability and the repeatability of an immune detection result. Therefore, the high-specificity monoclonal antibody aiming at the MPT64 protein is obtained, and the immunological characteristics of the monoclonal antibody are systematically identified, so that the monoclonal antibody has important significance for constructing a stable and reliable MPT64 antigen immunodetection system. Disclosure of Invention The invention aims to provide an antibody or antigen binding fragment thereof for resisting mycobacterium tuberculosis MPT64 protein, which is used as a key recognition molecule in an immune detection system for immunological detection of the MPT64 protein, and provides a foundation for constructing a stable and reliable mycobacterium tuberculosis related immune detection method and detection reagent. In a first aspect, the present invention provides an antibody or an antigen-binding fragment thereof against mycobacterium tuberculosis MPT64 protein, the antibody being capable of specifically binding to mycobacterium tuberculosis MPT64 protein, the ant