Single-Layer Lateral Flow Format Using Hydrophilic Matrix
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Solution Overview
Problem
Lateral flow tests face challenges due to material incompatibility and flow issues, requiring multiple materials with different properties, which complicates manufacturing and affects accuracy and efficiency.
Innovation Solution
A single-layer lateral flow format using a dry porous medium with a hydrophilic matrix comprising a network of fibers, including zones for sample application, conjugate release, capture testing, and absorbency, where labeled binding reagents are immobilized and released upon sample contact, and capture reagents bind to form complexes for detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple different materials are used for different parts of the test (sample wick, filtration material, conjugate release pad, reaction matrix, absorbent), then each component can have optimized properties for its specific function, but the device complexity and manufacturing difficulty increase due to material incompatibility and contact issues
Solution Approach 1:
The patent combines multiple previously separate materials (sample wick, filtration material, conjugate release pad, reaction matrix, and absorbent) into a single integrated porous support material. This single material performs all five functions simultaneously, eliminating material incompatibility and contact issues while simplifying manufacturing. The porous support is made hydrophilic through treatment with hydrophilic agents to enable proper liquid flow and functional performance.
Solution Approach 2:
The single porous support material is designed to be multi-functional, serving as the sample wick, filtration material, conjugate release pad, reaction matrix, and absorbent all in one. This universal material approach maintains the optimized performance of each individual function while eliminating the complexity of assembling multiple separate components.
2Reliability
If multiple overlapping pads of different materials are used, then specific functional requirements for each zone can be met, but flow consistency is adversely affected by boundaries between segments with different wicking rates
Solution Approach 1:
The patent eliminates the boundaries between multiple overlapping pads by using a single continuous porous support material. This removes the flow discontinuities and wicking rate mismatches that occur at interfaces between different materials, ensuring consistent and reliable liquid flow throughout the entire test device while maintaining functional specificity through zonal treatment of the single support.
3Ease of manufacture
If a single hydrophilic porous support material is used for all functions, then manufacturing is simplified and flow consistency is improved, but the ability to provide vastly different physical characteristics for each component is reduced
Solution Approach 1:
The patent applies local quality by treating different zones of the single porous support material with specific reagents to provide locally optimized properties. The support is made hydrophilic through treatment with hydrophilic agents, and different zones can be selectively treated to provide the specific functional characteristics needed for sample application, conjugate release, reaction, and absorption, all within a single unified material structure.
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 simplifies manufacturing, improves flow consistency, enhances accuracy, and reduces costs by using a single material for all functions, allowing for efficient detection of analytes in liquid samples.
Implementation Method 1
a wick to transport the sample to the test
Implementation Method 2
an absorbent where the sample is absorbed and the liquid is driven to flow along the test format
Implementation Method 3
the liquid is driven to flow along the test format
Data Source
AI summary
The present invention provides a lateral flow format and materials and methods for using the format in a variety of applications. More particularly, the present invention provides single-layer lateral flow formats, materials and methods for detecting the presence of an analyte using a test strip comprising a dry porous medium comprising a single hydrophilic matrix. Devices are also provided as well as methods of making and using the format. The format is particularly useful for diagnosis of physiological and genetic conditions. In addition, the present invention provides methods and materials for concentrating a reagent in a porous medium.