Miniaturized Lateral Flow Device for Nucleic Acid Detection

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Solution Overview

Problem

Current pathogen detection methods, particularly for nucleic acids, are complex, costly, and require sophisticated instrumentation, limiting their utility for field-deployable, point-of-care diagnostics and rapid screening due to reliance on PCR and fluorescence detection.

Innovation Solution

Development of miniaturized lateral flow chromatographic devices (LFM devices) that integrate isothermal nucleic acid amplification techniques, enabling rapid and sensitive detection of nucleic acids without the need for thermocyclers or fluorescence detection hardware, using labeled oligonucleotides and capture oligonucleotides immobilized on microporous membranes for hybridization-based detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If PCR and fluorescence detection are used for nucleic acid detection, then sensitivity and specificity are improved, but device complexity and cost increase

Engineering Contradiction:

Improvedetection sensitivityVSAvoidinstrumentation complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex fluorescence detection hardware with a simple lateral flow chromatographic system that uses capillary action and visual colorimetric detection. The detection mechanism shifts from optical fluorescence measurement to mechanical fluid flow and human visual inspection, eliminating the need for thermocyclers and fluorescence detectors while maintaining detection capability through isothermal amplification and labeled probe hybridization

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention employs disposable lateral flow test strips with integrated reagents (labeled detection oligonucleotides and capture oligonucleotides immobilized on microporous membranes) that are inexpensive to manufacture and use. Each test strip is a single-use device that combines multiple components into one affordable unit, making nucleic acid detection accessible without costly reusable instrumentation

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Adaptability or versatility

If DNA microarray technology is used for multiplexed detection, then information capacity increases, but device complexity and cost increase

Engineering Contradiction:

Improvemultiplexed detection capabilityVSAvoiddetection system complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The lateral flow device achieves multiplexed detection by incorporating multiple capture oligonucleotides targeting different nucleic acid sequences on a single test strip. Each capture zone can detect a different pathogen or genetic marker simultaneously, allowing one device to perform multiple diagnostic functions without requiring separate assays or complex instrumentation for each target

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Ease of operation

If conventional lateral flow immunoassays are used for rapid detection, then ease of use and cost are improved, but detection sensitivity for nucleic acids deteriorates

Engineering Contradiction:

Improvesimplicity of useVSAvoidnucleic acid detection sensitivity

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent enhances the sensitivity of lateral flow nucleic acid detection by incorporating isothermal nucleic acid amplification techniques that generate abundant target sequences before hybridization with labeled detection oligonucleotides. This pre-amplification step increases the concentration of detectable targets, enabling sensitive detection of nucleic acids using the simple lateral flow platform without requiring complex instrumentation

Inventive Principle:

Principle #35Parameter changes

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

LFM devices provide rapid, sensitive, and cost-effective detection of nucleic acids with reduced reagent use and sample volumes, enabling multiplexed assays and detection within minutes, suitable for field applications with minimal infrastructure.

Implementation Method 1

using labeled oligonucleotides and capture oligonucleotides immobilized on microporous membranes for hybridization-based detection

Methodology Applied

Scientific EffectHybridization:

Implementation Method 2

lateral flow chromatographic devices

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS10458978B2Miniaturized lateral flow device for rapid and sensitive detection of proteins or nucleic acids

Publication Date: 2019.10.29 TRIAD NATIONAL SECURITY LLC

AI summary

The invention provides miniaturized lateral flow chromatographic and lateral flow chromatographic microarray devices (LFM). The miniaturization of lateral flow nucleic acid detection achieved by the present invention offers reduced reagent use, femtomole sensitivity, excellent linear dynamic range, and rapid detection. Moreover, the small feature sizes of capture oligonucleotides renders the potential information capacity of the platform comparable to more traditional spotted fluorescence microarrays as well as improving sensitivity. The LFM devices exemplified herein enable analytes to be detected within 10 seconds from the time of sample introduction to the LFM device. Sample volumes may be as low as about 10 microliters, significantly reducing assay costs and ameliorating reagent storage logistics. Additionally, the miniaturization of lateral flow opens the door to highly multiplexed assays, allowing many proteins or nucleic acids to be detected in a single assay.