Lateral Flow Cassette Quantification via Digital Imaging

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Solution Overview

Problem

Current lateral flow chromatographic immunoassay tests are limited to providing only qualitative results, lacking the capability for quantitative analysis, which restricts their use in diagnosing and managing conditions at the point of care without centralized clinical facilities.

Innovation Solution

The development of a diagnostic test system that includes a lateral-flow chromatographic assay cassette with a capture ligand and reporter, along with a compact, portable testing device for data collection and analysis, enabling the generation of a two-point calibration curve for quantifying analytes in biological samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If lateral flow chromatographic immunoassay tests are used, then ease of use and rapid testing are improved, but quantitative analysis capability deteriorates

Engineering Contradiction:
Improveease of useVSAvoidquantitative analysis capability
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent merges the simplicity of lateral flow chromatographic immunoassay with quantitative analysis capability by integrating a portable testing device that captures images of the test strip and uses image processing algorithms to quantify analyte concentrations based on signal intensity measurements from the visual bands

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces complex centralized laboratory equipment with a portable testing device that uses digital imaging and computational algorithms to perform quantitative analysis, eliminating the need for expensive centralized equipment while maintaining measurement capability

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

2Measurement precision

If centralized clinical testing equipment is used, then quantitative analysis capability is improved, but device complexity and cost deteriorate

Engineering Contradiction:
Improvequantitative analysis capabilityVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the essential quantitative analysis function from complex centralized equipment and implements it in a portable device using digital imaging and image processing, removing the need for bulky laboratory equipment while maintaining measurement capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses disposable test strips with embedded calibration information that can be read by the portable device, replacing expensive reusable centralized equipment with low-cost single-use components that eliminate the need for complex calibration procedures

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

3Adaptability or versatility

If lateral flow chromatographic immunoassay tests are used, then portability and point of care capability are improved, but measurement precision deteriorates

Engineering Contradiction:
Improvepoint of care capabilityVSAvoidquantitative accuracy
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent incorporates calibration standards directly onto the test strip during manufacturing, performing the calibration setup in advance so that the portable device can directly quantify results without requiring separate calibration procedures at the point of care

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses digital imaging to create a copy of the visual test results and processes this digital copy through algorithms that convert image data into quantitative measurements, enabling accurate analysis without direct physical measurement equipment

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 solution allows for rapid, accurate, and affordable laboratory-quality testing at the point of care, providing quantitative results and eliminating the need for expensive centralized equipment and technical personnel, while enabling automated data reporting and decision support.

Implementation Method 1

a capture ligand capable of capturing and localizing at least one analyte of interest in a sample on an analysis surface

Methodology Applied
Scientific EffectSpecific binding:

Implementation Method 2

at least one reporter configured for interacting with at least one of the analyte of interest or the capture ligand

Methodology Applied
Scientific EffectReporter interaction:

Implementation Method 3

a light source capable of transmitting at least one wavelength of light configured to yield a detectable signal from the at least one reporter

Methodology Applied
Scientific EffectLight transmission:

Implementation Method 4

a detector positioned to capture the detectable signal from the at least one reporter

Methodology Applied
Scientific EffectSignal detection:

Data Source

PatentEP2839264B1Device for performing diagnostic test and methods for use thereof
Publication Date: 2017.07.26 EHRENKRANZ JOEL R L
  • EP2839264B1 patent drawingFigure 1
  • EP2839264B1 patent drawingFigure 2A~2B
  • EP2839264B1 patent drawingFigure 3A~3B

AI summary

Assay cassettes and testing devices that can be used to provide rapid, accurate, affordable, laboratory-quality testing at the point of care. Such assay cassettes and testing devices are designed to provide rapid, quantitative test results in a point-of-care setting or the like. Likewise, such assay cassettes and testing devices may eliminate or replace expensive, centralized clinical testing equipment and technical personnel. Such testing device may include automated data reporting and decision support. Methods for performing point of care diagnostic tests are also disclosed.