Lateral Flow Test Device Separable Reagent Zone
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Solution Overview
Problem
Conventional lateral flow devices are not amenable to adjusting detection thresholds and are not particularly useful for measuring analytes at low concentrations with high accuracy, often requiring buffer solutions that can affect results and pose safety concerns.
Innovation Solution
A test device with a separable second reagent zone that contains a mobilizable analyte-binding moiety, allowing for fluidic communication with a test strip to form an analyte:analyte-binding moiety complex, which then reacts with other specific binding moieties to produce a detectable complex indicative of the analyte's presence, minimizing the need for additional buffer solutions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional lateral flow devices are used for detecting analytes, then the device structure is simple and easy to manufacture, but the detection sensitivity and accuracy for low concentration analytes is insufficient
Solution Approach 1:
The device is divided into two separate reagent zones: a first reagent zone containing immobilized binding agents on the test strip, and a second reagent zone containing mobilizable analyte-binding moieties that can be separated from the test strip. This segmentation allows each zone to perform its specific function optimally, improving detection sensitivity while maintaining manufacturing simplicity.
Solution Approach 2:
A second reagent zone with mobilizable analyte-binding moieties is introduced as an intermediary between the sample and the first reagent zone. This intermediary enhances the binding efficiency and detection sensitivity for low concentration analytes, while the modular design keeps the overall device structure manageable.
2Measurement precision
If buffer solutions are used to extract analytes from samples, then the analyte extraction efficiency is improved, but the results may be affected and safety concerns arise
Solution Approach 1:
The harmful buffer solution extraction step is removed from the assay process. Instead, the device uses a direct flow-through mechanism where the liquid sample flows directly from the sample application area through the first and second reagent zones to the test result zone, eliminating the need for buffer solutions while maintaining analyte extraction efficiency.
Solution Approach 2:
The device enables self-service analyte extraction through the natural flow of the liquid sample. The sample's own flow properties drive it through the reagent zones without requiring external buffer solutions, thus avoiding contamination and safety issues while maintaining extraction efficiency.
3Adaptability or versatility
If conventional lateral flow devices require manual buffer addition, then the reagent preparation is flexible, but the manual operation increases and convenience decreases
Solution Approach 1:
The device is designed to automatically manage reagent delivery and sample flow without requiring manual buffer addition. The liquid sample naturally flows through the integrated reagent zones, and the separable second reagent zone automatically mobilizes binding moieties, eliminating manual operations while maintaining reagent preparation flexibility through the modular design.
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
The device provides high detection sensitivity and accuracy for analytes at low concentrations without the need for additional buffer solutions, reducing manual operation and safety concerns.
Implementation Method 1
the second reagent zone comprises a mobilizable analyte-binding moiety which exhibits specific binding to a first reagent that is disposed in dry state in said test strip
Implementation Method 2
the device can be configured to provide a fluidic flowpath when said second reagent zone is placed in fluidic communication with the test strip. The test device can have a flow path along which the liquid sample flows into the second reagent zone
Implementation Method 3
the mixture can flow into the first reagent zone and the test result zone to react with at least two other specific binding moieties such that a detectable complex indicative of the presence of said analyte:analyte-binding moiety complex is formed
Data Source
AI summary
The present invention relates to test devices, and in particular devices capable of detecting the presence or absence of an analyte in a sample, such as a liquid sample. Also provided are methods of using such devices for quantitative or qualitative measurement of one or more analytes in a liquid sample.