Portable Molecular Diagnostic Device for Point-of-Care Testing

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Solution Overview

Problem

Current molecular diagnostic testing methods are inadequate for point-of-care or in-home use due to complexity, high cost, and safety concerns, often resulting in inaccurate or delayed results, which can lead to misuse and antibiotic resistance issues.

Innovation Solution

A disposable, portable molecular diagnostic test device that includes a detection module with capture probes and reagents producing a visible signal for nucleic acid amplification, allowing for accurate and rapid visual output without the need for specialized equipment or training.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If centralized laboratory molecular diagnostics testing is used, then measurement precision is improved, but device complexity and loss of time increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidinstrumentation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The centralized laboratory testing system is segmented into a portable device that integrates sample processing, nucleic acid amplification, and detection functions into a single handheld unit, eliminating the need for complex centralized instrumentation while maintaining diagnostic accuracy

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device is designed to be self-contained with all necessary reagents, amplification components, and detection mechanisms integrated into the portable unit, allowing it to perform molecular diagnostics independently without requiring complex laboratory infrastructure or trained personnel

Inventive Principle:
Principle #25Self-service

2Measurement precision

If centralized laboratory molecular diagnostics testing is used, then measurement precision is improved, but loss of time increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidturn-around time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

Sample processing, nucleic acid amplification, and detection functions are merged into a single integrated portable device that can complete the entire molecular diagnostic workflow in one location, eliminating batch processing delays and enabling immediate results at the point of care

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device performs nucleic acid amplification and detection in rapid succession immediately after sample collection, eliminating the delay of transporting samples to centralized laboratories and waiting for batch processing before results are available

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If sophisticated optics and laser light sources are used, then measurement precision is improved, but object-affected harmful factors increase

Engineering Contradiction:
Improvedetection sensitivityVSAvoidsafety hazard
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The device uses disposable components and non-hazardous detection methods that do not require sophisticated optics or laser light sources, eliminating safety hazards while maintaining sufficient detection sensitivity for point-of-care use

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

Solution Approach 2:

Complex optical detection systems with lasers and sophisticated optics are replaced with simpler detection mechanisms that use non-hazardous light sources or alternative detection methods, eliminating safety risks associated with high-powered lasers while maintaining diagnostic capability

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Adaptability or versatility

If flexible laboratory-based systems are used, then adaptability is improved, but device complexity increases

Engineering Contradiction:
Improvetesting flexibilityVSAvoidsystem complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The portable device is designed with universal functionality to perform multiple molecular diagnostic tests using a single integrated platform, allowing it to adapt to different testing needs without requiring complex reconfiguration or additional specialized equipment

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

Enables rapid, accurate, and safe molecular diagnostic testing at the point of care or in-home settings, reducing the risk of misuse and improving timely treatment decisions.

Implementation Method 1

The second reagent includes a precipitating substrate formulated to catalyze the production of the visible signal by producing an insoluble colored product when the second reagent is in contact with the first reagent

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Implementation Method 2

The second reagent includes a precipitating substrate formulated to catalyze the production of the visible signal

Methodology Applied
Scientific EffectCatalysis: Catalysis

Implementation Method 3

The detection module includes a detection surface including a series of capture probes to which a first portion of the target amplicon is bound when the detection solution is conveyed

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS10675623B2Devices and methods for the detection of molecules using a flow cell
Publication Date: 2020.06.09 VISBY MEDICAL INC
  • US10675623B2 patent drawing
  • US10675623B2 patent drawing
  • US10675623B2 patent drawing

AI summary

A method includes conveying a detection solution containing a target amplicon into a detection module of a molecular diagnostic test device. The detection module includes a detection surface including a series of capture probes to which a first portion of the target amplicon is bound when the detection solution is conveyed. A first reagent formulated to produce a visible signal indicating a presence of the target amplicon is then conveyed into the detection module. The first reagent is bound to a second portion of the target amplicon when the first reagent is conveyed. A second reagent is conveyed into the detection module. The second reagent includes a precipitating substrate formulated to catalyze the production of the visible signal by producing an insoluble colored product when the second reagent is in contact with the first reagent. The method includes viewing the visible signal via a transparent portion of the detection module.