Immunochromatography Kit With Silver Amplification for TB Detection

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Solution Overview

Problem

Existing immunochromatographic methods for detecting Mycobacterium tuberculosis suffer from low sensitivity and specificity, leading to delayed or incorrect treatment due to cross-reactions with nontuberculous mycobacterial groups.

Innovation Solution

An immunochromatographic kit using monoclonal antibodies against lipoarabinomannan, combined with a compound containing silver and a reducing agent, to amplify detection signals and improve specificity and sensitivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a liquid culture method is used to detect mycobacterium tuberculosis, then the sensitivity of detection is improved, but the time required for detection increases significantly (1-3 weeks)

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The invention divides the detection process into two independent parallel pathways: a liquid culture pathway for high-sensitivity detection and a solid culture pathway for rapid detection. By segmenting the sample processing and using separate culture media (liquid MGIT medium and solid Lowenstein-Jensen medium), the system achieves both high sensitivity and rapid results simultaneously, resolving the contradiction between detection sensitivity and time consumption.

Inventive Principle:
Principle #1Segmentation

2Loss of time

If conventional solid culture methods are used, then the detection time is reduced, but the sensitivity and accuracy of detection deteriorate

Engineering Contradiction:
Improvedetection timeVSAvoiddetection sensitivity
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The invention segments the detection system into dual culture pathways, allowing the solid culture method to be used for rapid initial detection while the liquid culture method provides confirmatory high-sensitivity detection. This segmentation enables the system to overcome the sensitivity limitation of solid culture by combining results from both methods.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention introduces an automated detection system as an intermediary that monitors both liquid and solid culture pathways simultaneously. This intermediary system detects metabolic activity in liquid culture and colony formation in solid culture, providing objective and sensitive detection that overcomes the subjective visual inspection limitations of conventional solid culture methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If manual processing methods are used for culture and detection, then the equipment complexity is reduced, but the labor intensity and processing time increase

Engineering Contradiction:
Improveequipment simplicityVSAvoidprocessing efficiency
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

The invention implements self-service automation where the detection system automatically monitors culture growth by detecting metabolic parameters (oxygen consumption in liquid culture, colony formation in solid culture) without requiring manual intervention. The system automatically alerts when mycobacterium is detected, eliminating the need for daily manual inspection and significantly improving productivity while maintaining equipment simplicity.

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The kit achieves high-sensitivity and specificity in detecting Mycobacterium tuberculosis, enabling accurate diagnosis and differentiation from other mycobacterial species.

Implementation Method 1

magnetic separation unit having a magnetic bead for binding to the mycobacterium tuberculosis

Methodology Applied
Scientific EffectMagnetic separation: Magnetism

Implementation Method 2

immunochromatography unit having a test line and a control line

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 3

specific binding between an antibody and an antigen

Methodology Applied
Scientific EffectAntibody-antigen binding: Adsorption

Data Source

PatentEP3845903B1Immunochromatography kit, and method for detecting mycobacterium tuberculosis
Publication Date: 2026.05.06 FUJIFILM CORP
  • EP3845903B1 patent drawingFigure 1
  • EP3845903B1 patent drawingFigure 2
  • EP3845903B1 patent drawingFigure 3

AI summary

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.