Isothermal Nucleic Acid Detection System with Pre-configured Test Strip

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Solution Overview

Problem

Current nucleic acid detection methods, such as LFA and PCR, face challenges including low sensitivity and specificity, complex operation requirements, and lengthy detection times, particularly due to the need for specialized personnel and equipment like temperature cycling machines.

Innovation Solution

An integrated nucleic acid loop-mediated isothermal amplification and mobile device system that includes a test strip with pre-prepared reagents and compartments for sample, primer, and polymerase, utilizing a ceramic heating chip and temperature sensor for isothermal amplification, and a control unit for automated operation, powered by a battery, allowing for rapid and sensitive detection without specialized technical expertise.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If LAMP technology is used for nucleic acid amplification, then sensitivity and specificity are improved, but detection time increases to 40-60 minutes

Engineering Contradiction:
Improvedetection sensitivity and specificityVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent pre-configures all LAMP reaction reagents (primers, polymerase, dNTPs, buffer) in the test strip before use. This preliminary preparation eliminates the time-consuming step of reagent configuration during detection, reducing the overall detection time from 40-60 minutes to a shorter duration while maintaining the high sensitivity and specificity of LAMP technology

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If LAMP reagents are configured manually for each detection, then detection flexibility is maintained, but operation complexity increases and requires specialized technical personnel

Engineering Contradiction:
Improvedetection flexibilityVSAvoidoperation complexity
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The patent segments the LAMP detection system into a disposable test strip containing all reagents in separate compartments and a reusable main body device. This segmentation allows the complex reagent configuration to be pre-packaged in the test strip, eliminating the need for specialized personnel to manually configure reagents during each detection, while still allowing flexibility by using different pre-configured test strips for different detection targets

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs disposable test strips that contain all LAMP reagents pre-configured in separate compartments. These single-use test strips eliminate the need for specialized technical personnel to handle and configure complex reagents repeatedly, as each test strip is self-contained and ready-to-use, significantly reducing operation complexity while maintaining detection flexibility through variety of pre-configured strips

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

3Measurement precision

If indirect methods are used to verify LAMP results (LFA or pH measurement), then detection accuracy is improved, but device complexity and cost increase

Engineering Contradiction:
Improveresult verification accuracyVSAvoidverification system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses color-changing indicators within the test strip to directly visualize LAMP amplification results. The test strip contains pH-sensitive color indicators that change color in response to pH changes during amplification, or fluorescent indicators that can be observed under UV light. This direct color-based readout eliminates the need for complex indirect verification methods like LFA or electronic pH measurement systems, reducing device complexity and cost while maintaining result verification accuracy

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent creates a visual copy of the amplification result through color changes or fluorescence that can be directly observed or captured by a mobile device camera. This visual representation serves as a simplified copy of the molecular amplification event, eliminating the need for complex indirect verification systems while preserving the ability to accurately verify detection results

Inventive Principle:
Principle #26Copying

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 system simplifies the detection process, reduces assembly costs, and achieves high sensitivity and specificity, completing nucleic acid amplification in 30 minutes with direct interpretation of results, and allows for flexible primer changes to detect different pathogens.

Implementation Method 1

a heating unit comprising a ceramic heating chip and a temperature sensor to provide a temperature suitable for performing a loop-mediated isothermal amplification reaction

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 2

the plurality of compartments of the test strip are squeezed and destroyed by the pressure roller and the test strip rotating roller when the test strip passes through the gap

Methodology Applied
Scientific EffectMechanical force: Mechanical Force

Implementation Method 3

a control unit electrically connected to the delivery unit and the heating unit to control operations of the delivery unit and the heating unit

Methodology Applied
Scientific EffectThermal regulation:

Data Source

PatentUS20230313280A1Integrated nucleic acid loop-mediated isothermal amplification and mobile device system
Publication Date: 2023.10.05 NAT TAIWAN UNIV
  • US20230313280A1 patent drawing
  • US20230313280A1 patent drawing
  • US20230313280A1 patent drawing

AI summary

An integrated nucleic acid loop-mediated isothermal amplification and mobile device system is provided and includes a main body and a power supply, where the 5 main body at least has a delivery unit, a heating unit and a control unit, the control unit is electrically connected to the delivery unit and the heating unit, and the power supply is electrically connected to the main body. A method for operating the integrated nucleic acid loop-mediated isothermal amplification and mobile device system is also provided.