Integrated Biosensor Platform for One-Step Lateral Flow Testing

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current lateral flow devices for POC testing require multi-step procedures, separate components, and are prone to end-user errors due to the need for liquid sample extraction and precise delivery, making them cumbersome and less desirable for field applications.

Innovation Solution

A modular biosensor platform that integrates an immunoassay test strip with sample extraction and liquid delivery in a single-use, disposable format, utilizing a test receptacle with a central opening and a flex plate to create capillary force for analyte transfer through the test strip, providing a simple and accurate one-step testing process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If separate components (test strip, extraction buffer, pipette) are used for lateral flow testing, then the testing capability is comprehensive, but the device complexity and ease of operation deteriorate due to multi-step procedures and integration challenges

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

Solution Approach 1:

The patent merges the test strip, extraction buffer reservoir, and liquid transfer mechanism into a single integrated lateral flow device. The buffer reservoir is directly connected to the test strip, eliminating the need for separate pipettes and manual transfer steps. This integration maintains comprehensive testing capability while significantly reducing device complexity and improving ease of operation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated device performs multiple functions within a single unit: storing the extraction buffer, transferring the liquid sample, and conducting the immunoassay test. This multi-functionality allows the device to replace multiple separate components (buffer bottle, pipette, test strip) while maintaining adaptability for various testing applications.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If separate components with multi-step procedures are used, then the testing function is complete, but the ease of operation deteriorates due to end-user errors in liquid delivery volume and location

Engineering Contradiction:
Improvetesting functionVSAvoidease of operation
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

By combining the buffer reservoir and test strip into a single integrated device with a direct fluidic connection, the patent eliminates the manual liquid transfer step that causes user errors. The buffer is automatically delivered to the test strip through capillary action or pressure-driven flow, ensuring precise volume and location without requiring user skill or attention.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated device performs the liquid transfer function automatically through its internal design. The buffer reservoir and test strip are connected such that the liquid flows automatically from the reservoir to the test strip without requiring manual pipetting. This self-service mechanism eliminates end-user errors in liquid delivery volume and location while maintaining complete testing function.

Inventive Principle:
Principle #25Self-service

3Reliability

If a single-use disposable format is used, then the ease of operation and reliability improve, but the device complexity increases due to integration of extraction and delivery mechanisms

Engineering Contradiction:
ImprovereliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent integrates the buffer reservoir, transfer mechanism, and test strip into a single disposable unit. This merging of components into one integrated system improves reliability by eliminating contamination risks between uses and ensuring consistent performance, while the compact integration actually reduces overall complexity compared to managing multiple separate components.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent designs the entire lateral flow device as a single-use disposable unit. This disposable format improves reliability by eliminating cross-contamination and calibration issues between uses. The integrated design allows the entire device to be manufactured as a low-cost disposable item, where the simplicity of the integrated structure actually reduces manufacturing complexity compared to reusable devices with multiple moving parts.

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

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 and accurate detection of analytes from various substrates with minimal user training, reducing errors and complexity, and is compatible with standard test strip dimensions and digital readers for data recording.

Implementation Method 1

The restrictor port—in combination with the test strip chamber and a bottom portion of the test strip, forms a structural relationship that functions to create a capillary force that wicks the analyte from the bottom of the sleeve, through the restrictor port and up the test strip

Methodology Applied
Scientific EffectCapillary force: Capillary Action

Implementation Method 2

The sleeve also includes a resilient flex plate that extends into the test strip chamber and abuts the test strip

Methodology Applied
Scientific EffectElastic contact: Elasticity

Data Source

PatentUS11415578B2Biosensor platform for rapid diagnostic testing
Publication Date: 2022.08.16 THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY DEPARTMENT OF HEALTH & HUMAN SERVICES
  • US11415578B2 patent drawing
  • US11415578B2 patent drawing
  • US11415578B2 patent drawing

AI summary

The bio sensor platform is a rapid point-of-care (POC) device wherein detection of a target analyte from a liquid or solid substrate is performed in a single step using a fully integrated disposable test system that includes a test strip immunoassay. In operation, a user initiates the test by rupturing the bottom of a liquid-filled analyte capsule seated in a capsule sleeve. A small volume of liquid flows by capillary action from the capsule sleeve and through a restrictor port to a test strip chamber where contact with the absorptive sample pad of the test strip (among other things) moves liquid by capillary action upwardly through the test strip. The detection of the target analyte is resolved by the test strip reagents and the test results are obtained at a test result window where a portion of the test strip is exposed to the user.