Machine-Readable Lateral Flow Assay Using Bioelectrochemical Signals

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Solution Overview

Problem

Conventional lateral flow assays (LFAs) suffer from user errors due to faint color changes and reliance on visual cues, and smartphone applications for reading LFAs often produce inaccurate results under poor lighting conditions, making them unreliable for objective and accurate diagnostics.

Innovation Solution

A machine-readable LFA device that generates electrical signals based on bioelectrochemical reactions, using wireless chips to transmit data to smartphones for accurate result analysis, eliminating the need for visual indicators and reducing human error.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional lateral flow assays use visual color change indicators, then the device structure remains simple, but the measurement precision and reliability deteriorate due to faint color changes and user error

Engineering Contradiction:
Improvedetection accuracyVSAvoiddevice structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the optical/visual detection system with an electrochemical detection system. The LFA device incorporates working and reference electrodes that measure electrical potential differences generated by bioelectrochemical reactions at the test and control lines, substituting the mechanical/visual observation method with an electrical measurement system to achieve machine-readable, objective results

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

Solution Approach 2:

The patent introduces electrochemical mediators that facilitate electron transfer between the biochemical reactions at the test lines and the electrodes. These mediators enable the transduction of biochemical signals into electrical signals that can be measured and processed, serving as an intermediary between the biological recognition event and the electronic detection system

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If smartphone applications rely on visual cues under poor lighting conditions, then the device portability is maintained, but the measurement precision and reliability worsen due to inaccurate results

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidlighting condition dependency
Core Design Contradiction:
ReliabilityVSIllumination intensity

Solution Approach 1:

The patent replaces the light-dependent optical detection system with an electricity-based detection system. By measuring electrical potential differences generated through bioelectrochemical reactions, the system eliminates dependency on lighting conditions and external power sources, enabling reliable operation in resource-limited settings without compromising diagnostic reliability

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

Solution Approach 2:

The device generates its own electrical signals through bioelectrochemical reactions at the test lines, requiring no external power source. The electrochemical mediators and enzyme-substrate reactions self-generate the electrical potential needed for detection, making the system autonomous and independent of external lighting or power infrastructure

Inventive Principle:
Principle #25Self-service

3Loss of information

If manual visual reading of LFAs is used, then the device complexity remains low, but the loss of information increases due to user errors and subjective interpretation

Engineering Contradiction:
Improveuser error rateVSAvoidreading system
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent replaces the human visual interpretation system with an electronic measurement and communication system. The electrodes measure electrical potential differences objectively, and the results are transmitted via wireless communication (Bluetooth, WiFi, or NFC) to a computing device for automated analysis, eliminating subjective user interpretation and reducing information loss from human error

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

Solution Approach 2:

The system provides automated feedback through wireless communication between the LFA device and external computing devices. The electrical measurements are automatically processed, analyzed, and transmitted to provide objective diagnostic results, replacing the manual visual reading process with an automated feedback loop that reduces user error and information loss

Inventive Principle:
Principle #23Feedback

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

Provides objective, accurate, and automated test results through electrical signals, enabling reliable diagnostics even in resource-limited settings and facilitating integration with healthcare systems for large-scale data collection.

Implementation Method 1

a porous membrane structured to facilitate lateral flow

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

test and control zones coated with analyte-specific antibodies or antigens

Methodology Applied
Scientific EffectAntigen-antibody binding: Adsorption

Implementation Method 3

At least a portion of the porous membrane acts as a bioelectrochemical cell that generates an electrical signal

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Data Source

PatentEP4158342B1Machine readable diagnostic test devices and methods and apparatus to make and/or process the same
Publication Date: 2026.04.15 ABBOTT RAPID DIAGNOSTICS INT UNLTD
  • EP4158342B1 patent drawingFigure 1A~1B
  • EP4158342B1 patent drawingFigure 2A~2C
  • EP4158342B1 patent drawingFigure 2D~2E

AI summary

Methods, apparatus, systems, and articles of manufacture to make and/or process a diagnostic test device are disclosed. An example apparatus includes a sensor to measure a current between a first electrode and a second electrode of a bioelectrochemical cell coupled to a test zone corresponding to a target analyte on a porous media of a device; a processor to compare the current to a threshold; and when the current is more than the threshold, identify that the target analyte is present in a sample; and an antenna to wirelessly transmit results.