Segmented Lateral-Flow Capture Assay for Point-of-Care Quantitation

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Solution Overview

Problem

There is a need for point-of-care testing (POCT) devices that are easier to use, less prone to errors, more compact, and provide sufficient analytical performance, particularly in the detection of infectious diseases, with a lack of sensitive quantitation technology in existing POCT systems.

Innovation Solution

A lateral flow device comprising sections arranged along a horizontal axis with a sample collecting surface, a recognition molecule linked to a reporter molecule, and a substrate molecule generating a signal in response to a trigger, allowing for lateral flow and detection of analytes such as viruses, proteins, and pathogens, with optional calibration areas for quantitation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional laboratory testing is used, then analytical performance is maintained, but device portability and ease of use at point-of-care are compromised

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

Solution Approach 1:

The device is divided into multiple functional sections (sample application section, recognition molecule section, analyte capture section, substrate section) arranged along a horizontal axis. Each section performs a specific function in the assay process, enabling the entire testing sequence to be integrated into a single portable unit while maintaining laboratory-level analytical performance.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A lateral flow medium serves as an intermediary to transport the sample and generated complexes through the various sections. This intermediary enables the sample to move sequentially through each functional zone without requiring complex pumping or handling mechanisms, simplifying the overall device structure while maintaining controlled interaction between reagents.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If sensitive detection technology is implemented, then detection capability improves, but device compactness and portability deteriorate

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddevice compactness
Core Design Contradiction:
Measurement precisionVSVolume of moving object

Solution Approach 1:

The assay utilizes colorimetric detection where the substrate molecule generates a visible color change in response to the trigger from the reporter molecule. This optical signal can be detected by simple visual inspection or basic imaging devices, eliminating the need for bulky and expensive specialized detection instruments while maintaining sufficient sensitivity for diagnostic applications.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent replaces complex mechanical or electronic detection systems with optical detection principles. The reporter molecule generates a trigger that initiates a chemical reaction producing a detectable optical signal, substituting sophisticated electronic sensors with simpler optical detection methods that are more compatible with compact device design.

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

3Measurement precision

If quantitation capability is added, then analytical performance improves, but device complexity and ease of operation worsen

Engineering Contradiction:
Improvequantitation capabilityVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device incorporates a calibration area that provides reference information for quantitation. By comparing the signal intensity from the test section with the calibration reference, the system enables quantitative measurement of analyte concentration. This feedback mechanism allows quantitation capability to be integrated without requiring complex computational or electronic systems.

Inventive Principle:
Principle #23Feedback

4Reliability

If multiple functional sections are integrated, then assay performance improves, but ease of operation and device simplicity deteriorate

Engineering Contradiction:
Improveassay performanceVSAvoidease of operation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The lateral flow medium automatically guides the sample through all functional sections in the correct sequence without requiring user intervention or external control systems. The capillary action and gravity-driven flow enable the sample to self-navigate through the recognition molecule section, analyte capture section, and substrate section, maintaining reliable assay performance while preserving ease of operation.

Inventive Principle:
Principle #25Self-service

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 detection and quantitation of analytes in biological samples, suitable for point-of-care testing, reducing errors and enhancing analytical performance in compact devices.

Implementation Method 1

the reporter molecule generates a trigger; and the section 4 comprises a surface in contact with a substrate molecule generating a signal in response to the trigger

Methodology Applied
Scientific EffectChemiluminescence: Chemiluminescence

Data Source

PatentUS12422431B2Capture flow assay device and methods
Publication Date: 2025.09.23 BG NEGEV TECHNOLOGIES & APPLICATIONS LTD
  • US12422431B2 patent drawing
  • US12422431B2 patent drawing
  • US12422431B2 patent drawing

AI summary

Disclosed is a device including at least a section 1, a section 2, a section 3 and a section 4 wherein section 2 is coupled to section 1, section 3 is coupled to section 2 and comprises a surface functionalized with an analyte or equivalent thereof, section 4 is coupled to section 3, and section 1, section 2, section 3 and section 4 are arranged along a horizontal axis and in fluid communication allowing lateral flow from section 1 throughout all sections to section 4. Disclosed are also a kit and method for determining and quantifying the presence of an analyte in a sample.