RT-LAMP Pathogen Detection Device with Colorimetric Readout

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Solution Overview

Problem

Current methods for detecting viral nucleic acids, such as SARS-CoV-2, require professional expertise, sophisticated equipment, and laborious processes, limiting their availability and throughput, especially during pandemics, and do not provide real-time on-site surveillance capabilities.

Innovation Solution

A device and system comprising a sample module and a reaction module for isothermal amplification, allowing for self-sampling and self-performing detection of nucleic acid sequences, including viral pathogens, using a reverse-transcribed Loop-Mediated Isothermal Amplification (RT-LAMP) method that eliminates the need for RNA purification and can be performed with minimal equipment and reagents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If standard RT-qPCR detection methods are used, then detection accuracy is improved, but device complexity and operational difficulty increase

Engineering Contradiction:
Improvedetection accuracyVSAvoidequipment sophistication
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent changes the detection parameter from fluorescence-based qPCR to colorimetric LAMP, operating at isothermal conditions (65°C) rather than thermal cycling. This parameter change enables accurate pathogen detection using simple heating blocks or water baths, eliminating the need for complex real-time PCR instruments while maintaining diagnostic reliability through visual color readout

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the mechanical and electronic complexity of RT-qPCR instruments with a simplified thermal system. Instead of requiring programmed thermal cyclers, fluorescence detectors, and automated liquid handling, the invention uses basic heating devices to maintain isothermal conditions and visual observation for result detection, substituting sophisticated mechanical systems with simple thermal and optical principles

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

2Reliability

If professional sampling and detection procedures are required, then detection reliability is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvedetection reliabilityVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent enables non-experts to perform pathogen detection independently through self-sampling (collecting their own nasal or throat swabs) and self-detection (visualizing results without professional interpretation). The colorimetric LAMP assay provides intuitive color changes that require no specialized training to interpret, allowing community members to conduct their own surveillance while maintaining reliable detection through the robust isothermal amplification chemistry

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent uses colorimetric indicators that change color based on the presence of target nucleic acids during LAMP amplification. This visual signal transformation converts complex molecular detection into simple color observation, enabling non-experts to reliably interpret results without professional training while maintaining detection accuracy through the specific color response to amplification products

Inventive Principle:
Principle #32Color changes

3Measurement precision

If RNA purification steps are included, then measurement precision is improved, but loss of time increases

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

Solution Approach 1:

The patent extracts and eliminates the time-consuming RNA purification step from the detection workflow. By designing the LAMP assay to work directly with crude clinical samples containing viral RNA, the invention removes the intermediate purification phase while maintaining detection precision through the robustness of isothermal amplification chemistry that can tolerate sample impurities and directly amplify target sequences from raw extracts

Inventive Principle:
Principle #2Taking out (Extraction)

4Measurement precision

If multiple reagents and chemicals are used, then detection accuracy is improved, but device complexity increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidreagent complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges multiple separate steps and reagents into a single integrated isothermal LAMP reaction. Instead of requiring separate purification buffers, reverse transcription enzymes, and amplification reagents used in RT-qPCR, the invention combines all necessary components into one reaction mixture that performs reverse transcription and amplification simultaneously at constant temperature, reducing reagent complexity while maintaining detection accuracy through the efficiency of the LAMP chemistry

Inventive Principle:
Principle #5Merging (Combining)

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

Enables rapid, on-site detection of viral nucleic acids, increasing surveillance capabilities and reducing the need for specialized personnel and equipment, while providing accurate results for medium to high viral loads with minimal false positives.

Implementation Method 1

reverse-transcribed Loop-Mediated Isothermal Amplification (RT-LAMP) method

Methodology Applied
Scientific EffectLoop-mediated isothermal amplification:

Data Source

PatentUS20240002957A1Device, systems, kits and methods for rapid and simple detection of pathogens
Publication Date: 2024.01.04 TECHNION RES & DEV FOUND LTD
  • US20240002957A1 patent drawing
  • US20240002957A1 patent drawing
  • US20240002957A1 patent drawing

AI summary

The present disclosure provides devices, systems, kits and methods for rapid, simple self-sampling and self-performing detection of nucleic acid sequence of interest in a sample, specifically, nucleic acid sequences of pathogenic agents.