Monoclonal antibody of mycobacterium tuberculosis secreted protein 64 and its application

By preparing a dual-recognition monoclonal antibody capable of recognizing both wild-type and 63bp deletion mutant MPT64, and combining it with a double-antibody sandwich method, the false negative problem of MPT64 detection was solved, achieving high sensitivity and high detection rate in the diagnosis of Mycobacterium tuberculosis.

CN121159680BActive Publication Date: 2026-02-27WASON BIOTECH INC
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Patent Information

Application Number
CN202511725803.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-11-24
Publication Date
2026-02-27
Estimated Expiration
2045-11-24

AI Technical Summary

Technical Problem

Among existing methods for detecting Mycobacterium tuberculosis, the MPT64 antigen test is prone to false negative results, especially because the structural changes in the MPT64 protein caused by the 63bp deletion mutation cannot be recognized by existing monoclonal antibodies, resulting in missed detection and low detection rate.

Method used

A dual-recognition monoclonal antibody capable of simultaneously recognizing wild-type MPT64 (W-MPT64) and 63bp deletion mutant MPT64 (D-MPT64) was prepared. Using mouse hybridoma technology and a prokaryotic expression system, an enzyme-linked immunosorbent assay (ELISA) and fluorescence immunochromatographic assay were established using a dual-antibody sandwich method.

Benefits of technology

It significantly improves the detection rate and sensitivity of MPT64 protein in Mycobacterium tuberculosis, achieves positive detection earlier than existing methods, reduces the false negative rate, and is suitable for rapid diagnosis in primary healthcare institutions.

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Abstract

The application discloses a kind of simultaneously identifying wild type (W-MPT64) and 63bp deletion mutant (D-MPT64) Mycobacterium tuberculosis secreted protein 64 monoclonal antibody.The antibody heavy chain and light chain variable region amino acid sequence as shown in SEQ ID NO.1 and SEQ ID NO.5.The Mycobacterium tuberculosis MPT64 double antibody sandwich enzyme-linked immunosorbent assay and fluorescence immunoassay method established using the monoclonal antibody reach 1.5625 pg / mL, significantly higher than the minimum detection limit of prior art, can be used for qualitative and quantitative detection of Mycobacterium tuberculosis secreted protein 64.
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