Integrated Nucleic Acid Test System with Sensor-Driven Workflow

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Solution Overview

Problem

Current nucleic acid processing systems are complex and require specialized knowledge to operate, with workflows involving multiple steps for sample preparation, detection, and interpretation, limiting flexibility and efficiency in diagnostics, especially in point-of-care settings.

Innovation Solution

A system with a reaction chamber and multiple wells, equipped with sensors, allows for flexible configuration and reconfiguration of assays based on intermediate results, using fluid control to introduce primers and probes, and incorporating decision points to optimize the workflow, enabling real-time data-driven adjustments for nucleic acid analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If traditional nucleic acid processing systems are used, then detection precision is maintained, but device complexity and ease of operation deteriorate due to requiring specialized knowledge and multiple manual steps

Engineering Contradiction:
Improveease of operationVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent merges multiple separate workflow steps (sample preparation, amplification, detection, interpretation) into a single integrated instrument system. The reaction chamber combines all these functions in one device, eliminating the need for multiple manual operations and specialized knowledge while maintaining detection precision through automated integration of all processing stages.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system performs self-service through automated workflow execution. The instrument automatically executes nucleic acid extraction, amplification, and detection without requiring specialized operator intervention. The integrated design enables the system to self-manage the complex multi-step process, reducing operational complexity while maintaining high detection accuracy.

Inventive Principle:
Principle #25Self-service

2Productivity

If multiple separate tests are performed manually, then adaptability to different assays is maintained, but productivity and time efficiency deteriorate

Engineering Contradiction:
ImproveproductivityVSAvoidadaptability
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The integrated instrument provides universal functionality by performing multiple different nucleic acid tests (sequencing, SNP detection, gene expression analysis) within a single device. The reaction chamber can be configured for different assays without requiring separate instruments, thereby improving productivity while maintaining adaptability to various diagnostic applications.

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

Solution Approach 2:

The system incorporates dynamic reconfiguration capabilities where the workflow can be adjusted based on intermediate results. The instrument can dynamically switch between different test protocols and reconfigure parameters in real-time, enabling flexible adaptation to different diagnostic needs while maintaining high throughput and efficiency.

Inventive Principle:
Principle #15Dynamics

3Loss of time

If manual workflow steps are used, then flexibility in decision-making is maintained, but loss of time increases due to sequential processing requirements

Engineering Contradiction:
Improveloss of timeVSAvoidextent of automation
Core Design Contradiction:
Loss of timeVSExtent of automation

Solution Approach 1:

The integrated instrument enables continuous processing by executing workflow steps sequentially and automatically without interruption. Sample preparation, amplification, and detection occur in continuous cycles within the reaction chamber, eliminating idle time between manual operations. This continuous automated processing significantly reduces time loss while maintaining the flexibility to adjust workflows based on intermediate results.

Inventive Principle:
Principle #20Continuity of useful action

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 enables efficient, flexible, and automated nucleic acid analysis, allowing for dynamic workflow adjustments and optimized test performance, reducing the need for specialized expertise and improving diagnostic speed and accuracy.

Implementation Method 1

the incorporation of nucleotides (A,T,C,G) during extension of a DNA strand can be monitored by using an ISFET to measure the variation in ionic concentration as a by-product of the reaction. When a nucleotide extends a DNA strand, it releases pyrophosphate which is hydrolysed and generates H+ ions, reducing the pH.

Methodology Applied
Scientific EffectpH measurement:

Implementation Method 2

an ISFET can be used to detect hybridisation whereby a hybridisation probe attaches to a matching sequence on a DNA strand.

Methodology Applied
Scientific EffectIonic concentration detection:

Implementation Method 3

amplification of the nucleic acid or said fragments is performed within the chamber using an amplification primer or primers

Methodology Applied
Scientific EffectNucleic acid amplification:

Data Source

PatentUS11879116B2Integrated nucleic acid test system, instrument and method
Publication Date: 2024.01.23 DNAE GROUP HOLDINGS LIMITED
  • US11879116B2 patent drawing
  • US11879116B2 patent drawing
  • US11879116B2 patent drawing

AI summary

A method of analysing nucleic acid using apparatus comprising a reaction chamber and plurality of sensors located in the base of the chamber, with each sensor preferably located within a respective well. The method comprises flowing a fluid containing the nucleic acid or fragments thereof into the reaction chamber. While the chamber is fully or at least partially sealed, amplification of the nucleic acid or said fragments is performed within the chamber using an amplification primer or primers whilst detecting the generation of amplicons using said sensors. Sequencing or hybridisation is then performed on the amplicons, and sequencing or hybridisation is detected using said sensors.