Handheld Nucleic Acid Assay for Rapid Field Identification

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Solution Overview

Problem

Current methods for identifying biological agents and human individuals are cumbersome, requiring large machines and laboratories, and struggle with sensitivity, specificity, and the analysis of degraded DNA samples, especially in field settings where rapid and multiplex detection is needed.

Innovation Solution

A handheld device and method that extracts nucleic acid, amplifies it using isothermal NASBA, tags the amplicon with a capture probe and detector partner, and performs a lateral flow or ELISA assay to identify target organisms or individuals, enabling rapid, sensitive, and specific detection at the point of sample collection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If large machines and laboratories are used for identification, then measurement precision and reliability are improved, but device complexity and portability are worsened

Engineering Contradiction:
Improveidentification accuracyVSAvoiddevice portability
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The identification system is divided into separate functional modules: nucleic acid extraction module, amplification module, and detection module. Each module can be independently optimized and combined, allowing the complex identification process to be distributed across portable components rather than requiring a single large laboratory instrument.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A portable amplification device serves as an intermediary between sample collection and laboratory analysis. This intermediate step enables field-based preprocessing of samples, reducing the need to transport entire samples to laboratories while maintaining identification accuracy through standardized amplification protocols.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If traditional amplification and hybridization methods are used, then measurement precision is improved, but productivity and ease of operation are worsened

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddetection speed
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The system changes the physical parameters of the detection process by using isothermal amplification instead of thermal cycling, and by implementing real-time detection without post-amplification processing. These parameter changes maintain detection sensitivity while dramatically reducing the time required for identification.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The amplification and detection processes are continuous rather than sequential. The system performs real-time detection during the amplification process itself, eliminating idle time between steps and enabling rapid identification without compromising sensitivity through continuous monitoring of the amplification reaction.

Inventive Principle:
Principle #20Continuity of useful action

3Adaptability or versatility

If multiplex detection format is implemented, then adaptability is improved, but device complexity and ease of manufacture are worsened

Engineering Contradiction:
Improvemultiplex detection capabilityVSAvoidassay complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The portable amplification device is designed with universal applicability for detecting multiple different targets simultaneously. The system uses a standardized amplification platform that can accommodate various probe sets and detection chemistries, allowing the same device to perform singleplex or multiplex detection without requiring different hardware configurations.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 rapid, cost-effective, and sensitive identification of multiple biological agents or individuals in urgent situations, reducing the need for laboratory transport and enabling analysis of degraded samples, with the device being lightweight and portable.

Implementation Method 1

amplifying the extracted nucleic acid to form a nucleic acid amplicon

Methodology Applied
Scientific EffectIsothermal amplification:

Implementation Method 2

amplifies it using isothermal NASBA

Methodology Applied
Scientific EffectNASBA:

Implementation Method 3

tags the amplicon with a capture probe and detector partner

Methodology Applied
Scientific EffectHybridization:

Implementation Method 4

performs a lateral flow or ELISA assay

Methodology Applied
Scientific EffectLateral flow:

Implementation Method 5

performs a lateral flow or ELISA assay

Methodology Applied
Scientific EffectELISA:

Data Source

PatentUS11459619B2Handheld nucleic acid-based assay for rapid identification
Publication Date: 2022.10.04 JOHNS HOPKINS UNIVERSITY
  • US11459619B2 patent drawing
  • US11459619B2 patent drawing
  • US11459619B2 patent drawing

AI summary

A method for identifying a predefined target organism includes extracting a nucleic acid from a sample to form an extracted nucleic acid, amplifying the extracted nucleic acid to form a nucleic acid amplicon, tagging the nucleic acid amplicon with a capture probe and a detector partner to form a detector partner-nucleic acid amplicon-capture probe complex, and performing a detection assay on the detector partner-nucleic acid amplicon-capture probe complex to identify whether the predefined target organism is present in the sample.