Lateral Flow Test Strip with Dual Matrix Interface

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Solution Overview

Problem

Current lateral flow assays often rely on pre-immobilized reagents, which can limit sensitivity and increase costs, and there is a need for more efficient and cost-effective methods for detecting biological compounds, especially in point-of-care clinical diagnostics that can be used by untrained personnel.

Innovation Solution

A novel lateral flow test strip design where all detection reactants are movably bound to a first flow matrix, with a capture zone formed at the interface between two matrices of different characteristics, allowing for the accumulation of detectable products without pre-immobilized reagents, enhancing sensitivity and reducing costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If pre-immobilized reagents are used in lateral flow assays, then the assay structure is simplified and manufacturing is easier, but sensitivity is limited and costs increase

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

Solution Approach 1:

The test strip is divided into distinct functional zones: a first flow matrix containing movably bound detection reactants, a second flow matrix with different porosity characteristics, and a capture zone at their interface. This segmentation allows each zone to perform its specific function optimally while maintaining overall system simplicity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The interface between the first and second flow matrices serves as an intermediary capture zone that concentrates the detectable product. This intermediate region facilitates the accumulation of reaction products without requiring pre-immobilized reagents, thereby enhancing sensitivity while maintaining structural simplicity

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If pre-immobilized reagents are used in lateral flow assays, then device fabrication is simplified, but manufacturing costs increase

Engineering Contradiction:
Improvedevice fabrication simplicityVSAvoidcost-effectiveness
Core Design Contradiction:
Ease of manufactureVSQuantity of substance

Solution Approach 1:

The detection reactants are bound movably to the first flow matrix rather than being rigidly immobilized, allowing them to move freely within the matrix pores. This dynamic binding enables the reactants to interact more effectively with the analyte while using less expensive materials and simplifying the manufacturing process

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes the porosity parameter by using two flow matrices with different porosity characteristics. The first matrix has higher porosity to allow reactant movement, while the second matrix has lower porosity to concentrate the detectable product at the interface, optimizing both manufacturing and detection performance

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If detection reactants are movably bound to the first flow matrix, then sensitivity is enhanced, but the complexity of reagent binding increases

Engineering Contradiction:
Improvedetection sensitivityVSAvoidreagent binding complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection reactants bound to the first flow matrix are mobile and can autonomously move within the matrix pores to interact with analyte molecules. This self-service mechanism eliminates the need for complex pre-immobilization procedures while enhancing detection sensitivity through increased reactant-analyte interaction opportunities

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

This design improves the sensitivity and cost-effectiveness of lateral flow assays by allowing for the detection of enzymes and their substrates in bodily fluids, providing a clear, visible signal at the interface between the matrices, suitable for qualitative, semi-quantitative, or quantitative analysis without the need for additional equipment.

Implementation Method 1

The sample is drawn along the strip by capillary action, traveling through an indicator zone

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

The detection composition is selected so as to produce at least one detectable product upon exposure to the analyte

Methodology Applied
Scientific EffectChemical reaction: Chemical Bonding

Implementation Method 3

The first matrix is of higher porosity than the second matrix to allow higher permeation rate of the detectable product through the first matrix

Methodology Applied
Scientific EffectPorosity difference: Porosity

Data Source

PatentUS7704702B2Test strip for lateral flow assays
Publication Date: 2010.04.27 INVERNESS MEDICAL SWITZERLAND GMBH
  • US7704702B2 patent drawing
  • US7704702B2 patent drawing
  • US7704702B2 patent drawing

AI summary

A test strip configured for the detection of an analyte in a fluid sample and methods for manufacturing and for using the same. The test strip comprises a first flow matrix and a second flow matrix sequentially arranged to form an interface therebetween. The first flow matrix comprises a detection composition movably bound thereto, wherein the detection composition when exposed to the analyte produces at least one detectable product and wherein the first and second solid matrices are selected so as to accumulate the at least one detectable product at the interface between the two matrices, when the fluid sample travels from the first flow matrix to the second flow matrix.