Nucleic Acid Amplification for Drug Resistant TB Identification

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Solution Overview

Problem

Current methods for diagnosing and characterizing tuberculosis infection, particularly drug-resistant TB, are inadequate, leading to delayed treatment and increased spread of resistant strains, especially in developing countries where treatment is longer, more costly, and has lower cure rates.

Innovation Solution

A method involving nucleic acid amplification assays using reagents such as primers and probes to detect the presence of Mycobacterium complex and identify resistance to rifampicin and isoniazid by targeting specific mutations in rpoB, katG, and inhA regions, enabling timely and accurate identification of drug-resistant TB.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current diagnostic methods are used for tuberculosis, then diagnosis can be performed, but identification of drug-resistant TB is delayed and imprecise

Engineering Contradiction:
Improveidentification accuracy of drug-resistant TBVSAvoiddiagnosis time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs preliminary identification of drug-resistant TB strains by detecting specific genetic mutations (rpoB for rifampicin resistance, katG and inhA for isoniazid resistance) before initiating treatment. This preliminary genetic analysis allows clinicians to know the resistance profile in advance, eliminating delays in treatment customization and enabling immediate selection of appropriate antibiotics.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces traditional mechanical culture-based diagnostic methods with molecular biology techniques (PCR-based genetic detection). This substitution enables rapid amplification and detection of resistance-associated gene mutations, providing precise identification of drug-resistant TB strains within hours rather than weeks, thereby significantly reducing diagnosis time while improving accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If treatment is delayed for drug-resistant TB, then treatment can be initiated, but spread of resistant strains increases

Engineering Contradiction:
Improvespread of resistant strainsVSAvoidtreatment initiation time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The diagnostic method performs preliminary detection of drug resistance mutations before treatment begins, allowing immediate implementation of targeted therapy. By identifying resistant strains upfront through genetic analysis of rpoB, katG, and inhA genes, the system enables clinicians to start appropriate treatment without waiting for culture results, thereby preventing further transmission of resistant bacteria to other individuals.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies preliminary anti-action by detecting and identifying drug-resistant TB strains before they can spread further. Through rapid genetic detection of resistance mutations, the system enables immediate isolation and targeted treatment of infected individuals, counteracting the transmission process before it can significantly increase the spread of resistant strains in the community.

Inventive Principle:
Principle #9Preliminary anti-action

3Reliability

If standard treatment protocols are used without resistance identification, then treatment can be administered, but treatment effectiveness decreases and costs increase

Engineering Contradiction:
Improvetreatment effectivenessVSAvoiddiagnostic assay complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent performs preliminary identification of specific resistance mutations (rpoB for rifampicin, katG and inhA for isoniazid) before treatment selection. This preliminary genetic characterization enables clinicians to choose targeted antibiotics based on the actual resistance profile, ensuring treatment effectiveness from the start and avoiding the trial-and-error approach that wastes time and resources.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The diagnostic system segments the resistance detection process into specific modular assays for different resistance mechanisms: rpoB mutation detection for rifampicin resistance, katG mutation detection for isoniazid resistance, and inhA promoter region analysis. This segmentation allows the complex diagnostic task to be divided into manageable, targeted tests, each addressing a specific resistance pathway, thereby improving reliability while making the overall system more manageable.

Inventive Principle:
Principle #1Segmentation

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

This approach allows for immediate identification of drug-resistant TB, facilitating appropriate treatment and reducing the spread of resistant strains, thereby improving treatment outcomes and public health.

Implementation Method 1

nucleic acid amplification assays using reagents such as primers and probes to detect the presence of Mycobacterium complex and identify resistance to rifampicin and isoniazid by targeting specific mutations in rpoB, katG, and inhA regions

Methodology Applied
Scientific EffectNucleic acid amplification:

Data Source

PatentUS11225693B2Compositions and methods for identifying drug resistant tuberculosis
Publication Date: 2022.01.18 ABBOTT MOLECULAR INC
  • US11225693B2 patent drawing
  • US11225693B2 patent drawing
  • US11225693B2 patent drawing

AI summary

Provided herein are compositions and methods for diagnosing and characterizing tuberculosis infection. In particular, provided herein are compositions and methods for identifying drug resistant tuberculosis.