Portable Nucleic Acid Kit Using Self-Heating Pack for Field Testing

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Solution Overview

Problem

Current nucleic acid-based infection diagnostic testing requires controlled laboratory settings, extensive resources, and trained personnel, making it challenging for scalable, rapid, and cost-effective testing outside of laboratories, particularly due to manual sample preparation and amplification processes.

Innovation Solution

A self-contained kit for nucleic acid amplification and detection that includes a sampling swab, heat activation reagents, nucleic acid assay reagents, and a portable heating reaction chamber, allowing for manual operation by laypersons without specialized training, with results interpreted using a mobile app or printed chart, enabling direct consumer testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual sample preparation and amplification processes are used in controlled laboratory settings, then testing accuracy and reliability are maintained, but testing time, resource requirements, and operational complexity increase significantly

Engineering Contradiction:
Improvetesting accuracyVSAvoidtesting time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The kit divides the nucleic acid testing process into distinct functional modules: sampling swab, heat activation reagents, nucleic acid assay reagents, and separate reaction chambers. This segmentation allows each component to be optimized independently and enables parallel processing of multiple samples, reducing overall testing time while maintaining accuracy through controlled reagent delivery and reaction conditions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The kit includes pre-packaged reagents and pre-defined procedural steps that prepare everything in advance. The heat activation reagents and nucleic acid assay reagents are pre-positioned in separate chambers, and the sampling swab is pre-designed with specific absorption characteristics. This preliminary preparation eliminates the need for complex in-lab setup and reduces testing time while ensuring consistent, reliable results.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If manual sample preparation and amplification processes are used in controlled laboratory settings, then testing reliability is maintained, but device complexity and resource requirements increase

Engineering Contradiction:
Improvetesting reliabilityVSAvoidoperational complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The kit is designed to be self-contained with all necessary reagents, chambers, and instructions included. The heat activation reagents automatically initiate the amplification process when mixed with the sample, and the reaction chambers are pre-configured to contain all required components. This self-service design eliminates the need for complex laboratory equipment and trained personnel, reducing operational complexity while maintaining testing reliability through controlled, repeatable procedures.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The kit combines multiple functions into integrated components: the sampling swab integrates sample collection and initial lysis, the heat activation reagents combine heating function with reaction initiation, and the reaction chambers merge sample preparation with amplification and detection. This merging reduces the number of separate steps and components needed, simplifying operation while maintaining reliable testing through carefully integrated chemistry and physics.

Inventive Principle:
Principle #5Merging (Combining)

3Productivity

If large-scale lab automation processes are used, then testing throughput increases, but facility space and infrastructure requirements increase

Engineering Contradiction:
Improvetesting throughputVSAvoidfacility space
Core Design Contradiction:
ProductivityVSArea of stationary object

Solution Approach 1:

The kit extracts the essential nucleic acid amplification function from large-scale laboratory automation systems and packages it in a portable, self-contained format. By removing the need for complex automated equipment, large facility spaces, and specialized infrastructure, the kit enables high-throughput testing in minimal space. Multiple samples can be processed in parallel using identical portable kits, achieving scalability without requiring expansion of laboratory infrastructure.

Inventive Principle:
Principle #2Taking out (Extraction)

4Productivity

If sequencing technologies with barcoded sample templates are used for scaleup testing, then parallel processing capacity increases, but manual preparation steps and data analysis complexity increase

Engineering Contradiction:
Improveparallel processing capacityVSAvoidprocess complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The kit uses disposable, single-use reagent chambers and sampling swabs that are pre-configured for a specific testing procedure. These single-use components eliminate the need for expensive, complex automated sequencing equipment and manual data analysis infrastructure. The simplified chemistry-based detection provides sufficient throughput for public health monitoring without requiring sophisticated bioinformatics pipelines or specialized computational resources.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

Facilitates rapid, low-cost, and scalable nucleic acid testing outside laboratory settings, reducing the risk of infection and enabling immediate result generation and data collection for disease tracking, while minimizing human intervention and resource requirements.

Implementation Method 1

heat activation reagents

Methodology Applied
Scientific EffectExothermic reaction: Exothermic Reaction

Data Source

PatentUS12030056B2Kit, apparatus and method for a portable nucleic acid assay
Publication Date: 2024.07.09 HASU BIOTECH LTD
  • US12030056B2 patent drawing
  • US12030056B2 patent drawing
  • US12030056B2 patent drawing

AI summary

The self-contained kit comprises methods for receiving and preparing the biological samples for the nucleic acid amplification and sensing the presence of the target assay. The kit consists of a self-heating pack to provide the heat for nucleic acid sample preparation and amplification processes. The change of the amplification is indicated through colorimetric or turbidity sensing and detected through a mobile phone camera and associated mobile application for photographic scanning of physical or chemical differences of the samples to produce the test results.