Immunochromatographic kit and method for detecting mycobacterium tuberculosis

a technology immunochromatography, which is applied in the field of immunochromatographic kits for detecting mycobacterium tuberculosis, can solve the problems of lack of specificity and diagnostic sensitivity

Inactive Publication Date: 2021-08-26
FUJIFILM CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]An object of the present invention is to provide an immunochromatographic kit and a method, which are capable of detecting Mycobacterium tuberculosis with high-sensitivity and specificity.
[0009]As a result of intensive studies to achieve the above-mentioned object, the inventors of the present invention have found that it is possible to detect Mycobacterium tuberculosis with high-sensitivity and specificity by incorporating a compound containing silver, and a reducing agent capable of reducing silver ions, and by allowing at least one of a first antibody or a second antibody to be a monoclonal antibody, in an immunochromatographic kit for detecting Mycobacterium tuberculosis, the kit including a label substance modified with the first antibody against lipoarabinomannan, and a porous carrier having a reaction site holding the second antibody against lipoarabinomannan. Therefore, the inventors of the present invention have completed the present invention.

Problems solved by technology

Lack of diagnostic sensitivity, lack of specificity for Mycobacterium tuberculosis caused by cross-reaction with a nontuberculous mycobacterial group due to use of polyclonal antibodies, and the like have been pointed out in existing kits and methods for detecting lipoarabinomannan (LAM) and diagnosing tuberculosis, which is an infectious disease.

Method used

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  • Immunochromatographic kit and method for detecting mycobacterium tuberculosis
  • Immunochromatographic kit and method for detecting mycobacterium tuberculosis
  • Immunochromatographic kit and method for detecting mycobacterium tuberculosis

Examples

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examples

[0162]Immunochromatographic kits of an example and a comparative example are Mycobacterium tuberculosis antigens-detecting immunochromatographic kits which are for detecting lipoarabinomannan antigens as a test substance.

[0163](1) Production of Immunochromatographic Kit

[0164](1-1) Production of Anti-Lipoarabinomannan Antibody-Modified Gold Colloid as Label Substance Modified with First Substance that can Bind to Test Substance

[0165]1 mL of a 50 mmol / L of KH2PO4 buffer (pH 8.0) was added to 9 mL of a solution (Product No.: EM. GC50, manufactured by Boston Biomedical Inc.) containing gold colloid having a diameter of 50 nm to adjust a pH. Thereafter, 1 mL of a solution containing 20 μg / mL of an anti-lipoarabinomannan monoclonal antibody (antibody A194-01 produced according to a method for producing A-194-01 described in WO2017 / 139153A (DETAILED DESCRIPTION D. Anti-LAM and Anti-PIM6 / LAM Antibodies 1. A194-01)) was added thereto and stirred for 10 minutes. Thereafter, after the solution...

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Abstract

An object of the present invention is to provide an immunochromatographic kit and a method, which are capable of detecting Mycobacterium tuberculosis with high-sensitivity and specificity. According to the present invention, an immunochromatographic kit for detecting Mycobacterium tuberculosis is provided, the kit including: a label substance modified with a first antibody against lipoarabinomannan; a porous carrier having a reaction site holding a second antibody against lipoarabinomannan; a compound containing silver; and a reducing agent reducing silver ions, in which at least one of the first antibody or the second antibody is a monoclonal antibody.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation of PCT International Application No. PCT / JP2019 / 034112 filed on Aug. 30, 2019, which claims priority under 35 U.S.C § 119(a) to Japanese Patent Application No. 2018-163097 filed on Aug. 31, 2018. Each of the above application(s) is hereby expressly incorporated by reference, in its entirety, into the present application.REFERENCE TO SEQUENCE LISTING SUBMITTED VIA EFS-WEB[0002]This application includes an electronically submitted sequence listing in .txt format. The .txt file contains a sequence listing entitled “2021-04-19_2870-0780PUS1_ST25.txt” created on Apr. 19, 2021 and is 13,087 bytes in size. The sequence listing contained in this .txt file is part of the specification and is hereby incorporated by reference herein in its entirety.BACKGROUND OF THE INVENTION1. Field of the Invention[0003]The present invention relates to an immunochromatographic kit for detecting Mycobacterium tuberculosis, the kit...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/569G01N33/548C07K16/12
CPCG01N33/5695G01N33/548C07K16/1289G01N2333/35G01N2400/00G01N2405/00G01N2469/10G01N2400/02G01N33/54388A61K39/04
Inventor OHARA, TOMOYAOYABU, NATSUKIWADA, ATSUHIKOKATADA, JUNICHIUJIHARA, DAI
Owner FUJIFILM CORP
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