Amphipathic Polymer Assay Device for Rapid Lipid Measurement

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Solution Overview

Problem

Lateral flow assay devices for blood analysis, particularly for cholesterol and lipid testing, face challenges with uneven fluid flow and accuracy due to reliance on capillary action, which is slow and unsuitable for small samples, and existing methods for cholesterol assays are complex, time-consuming, and require specialized equipment.

Innovation Solution

The use of amphipathic polymers, such as polyethylene glycol, to enhance fluid flow and interaction between hydrophobic reagents and analytes in assay devices, allowing for faster and more controlled lateral fluid flow without the need for porous membranes and reducing the reliance on organic solvents, enabling direct measurement of lipoprotein concentrations in blood samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If capillary action is used for fluid flow in lateral flow devices, then the device structure is simple, but the fluid flow is uneven and slow, reducing assay accuracy and speed

Engineering Contradiction:
Improvedevice structureVSAvoidassay speed
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

A wick material is introduced as an intermediary component between the sample application area and the test line. The wick actively draws fluid through capillary action, ensuring uniform and controlled fluid flow across the test area, thereby improving both assay speed and accuracy without significantly increasing device complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The wick is made from porous material that provides capillary forces to drive fluid flow. The porous structure enables the wick to absorb and transport fluid uniformly across the test area, resolving the issue of uneven flow while maintaining a simple device structure

Inventive Principle:
Principle #31Porous materials

2Device complexity

If capillary action alone is used for fluid flow, then the device is simple, but the assay is slow and unreliable due to inconsistent fluid wicking

Engineering Contradiction:
Improvedevice structureVSAvoidfluid flow consistency
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The wick acts as a mediator that ensures reliable and consistent fluid flow to the test area. By introducing this intermediate component, the system achieves uniform fluid distribution and eliminates the unreliability of capillary action alone, while keeping the overall device structure simple

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of manufacture

If organic solvents are used to dissolve hydrophobic reagents, then the reagents can be properly dissolved, but the method becomes complex and time-consuming, requiring specialized equipment

Engineering Contradiction:
Improvereagent preparationVSAvoidassay system complexity
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The invention changes the chemical parameter of the solvent system by using amphipathic polymers that can solubilize hydrophobic reagents in aqueous environments. This eliminates the need for organic solvents and complex preparation procedures, simplifying both manufacture and device complexity

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

Amphipathic polymers are used as composite materials that combine hydrophilic and hydrophobic properties. These polymers enable the dissolution of hydrophobic reagents in aqueous solutions without requiring organic solvents, thereby simplifying the assay system while maintaining ease of manufacture

Inventive Principle:
Principle #40Composite materials

4Quantity of substance

If small blood samples are used for testing, then the sample collection is feasible at point of care, but the membrane may dry before assay completion or insufficient fluid reaches the test area

Engineering Contradiction:
Improvesample volumeVSAvoidassay completion
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The wick serves as an intermediary that efficiently transports small volumes of blood sample to the test area. Its capillary action ensures that sufficient fluid reaches the test line and remains there long enough for the assay to complete, preventing premature drying even with minimal sample volumes

Inventive Principle:
Principle #24Intermediary (Mediator)

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 approach enables rapid, efficient, and accurate measurement of lipoprotein concentrations, facilitating point-of-care cholesterol assays with improved speed and accuracy, suitable for small samples and reducing the need for specialized equipment.

Implementation Method 1

Such devices rely on capillary action of the fluids alone. Unfortunately, variations associated with sample transfer and diffusion of the sample to the membrane result in a flow that is largely Uncontrolled and uneven

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

the passage of fluid along the flow path is greater than that expected by capillary action alone

Methodology Applied
Scientific EffectAmphipathic polymer-enhanced lateral flow: Wetting

Implementation Method 3

enhance lateral flow and reagent mixing on assay devices

Methodology Applied
Scientific EffectHydrophobic interaction: Hydrophobe

Data Source

PatentEP2321050B1Assay device and methods
Publication Date: 2014.09.03 L3 TECH
  • EP2321050B1 patent drawingFigure 1
  • EP2321050B1 patent drawingFigure 2a~2c
  • EP2321050B1 patent drawingFigure 3a~3b

AI summary

The present invention relates to the use of amphipathic polymers to enhance lateral flow and reagent mixing on assay devices. More specifically, the invention relates to use of an amphipathic polymer in assay methods including a device for determining the concentration of lipids in blood serum or plasma.