Lateral Flow Devices with Instrument Controlled Fluidics
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Solution Overview
Problem
Existing lateral flow diagnostic devices are limited by their inability to perform quantitative assays due to lack of rigorous wash steps, amplification, and high sensitivity detection, making them unsuitable for detecting low abundance analytes without laboratory equipment.
Innovation Solution
An instrument-controlled diagnostic assay device with an injector pump for controlled fluid delivery, incorporating electro-osmotic flow and integrated chemical entities like luminogenic, fluorogenic, and chemiluminescent substrates for reagent addition, washing, and amplification within the device, enabling quantitative detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If lateral flow devices use visually observable reporters for rapid detection, then ease of operation and speed are improved, but measurement precision and sensitivity deteriorate
Solution Approach 1:
The patent changes the detection parameter from visual observation to instrument-based measurement of light emission (chemiluminescence or fluorescence). This allows the device to maintain simplicity in sample application while achieving quantitative detection capabilities through instrumental measurement of signal intensity.
Solution Approach 2:
The patent replaces the mechanical/visual detection system with an optical detection system using chemiluminescent or fluorescent reporters measured by instruments. This substitution enables quantitative analysis while preserving the simplicity of the lateral flow format for sample application.
2Device complexity
If lateral flow devices lack rigorous wash steps, then device complexity and ease of operation are improved, but measurement precision and sensitivity deteriorate
Solution Approach 1:
The patent replaces mechanical wash steps with a different detection mechanism (chemiluminescence/fluorescence) that inherently provides high signal-to-noise ratios. The instrumental detection of light emission from specific reporters allows quantitative measurement without requiring extensive washing to remove unbound conjugate.
Solution Approach 2:
The patent changes the detection parameter to light emission measurement, which provides inherent signal amplification and specificity. This parameter change eliminates the need for rigorous wash steps while maintaining or improving measurement precision through the specificity of optical detection.
3Device complexity
If lateral flow devices use capillary flow without active pumping, then device complexity and ease of operation are improved, but measurement precision and reliability deteriorate due to flow rate variability
Solution Approach 1:
The patent replaces passive capillary flow with active electro-osmotic pumping to achieve controlled, reproducible fluid delivery. This substitution maintains the simplicity of the lateral flow format while improving measurement precision through consistent flow rates that eliminate variability in signal intensity.
Solution Approach 2:
The patent uses electro-osmotic flow (a form of hydraulic control) to actively pump fluids through the device. This provides precise control over flow rates and timing, ensuring reproducible delivery of reagents and samples while maintaining the portability and simplicity of the device 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
Enables quantitative detection of low abundance analytes with improved sensitivity and reduced variability, maintaining the simplicity and cost-effectiveness of lateral flow devices while integrating advanced fluidic capabilities.
Implementation Method 1
The flow path is actively pumped by electro-osmosis to a receiving element fluid-receiving location
Implementation Method 2
The isolation means is an air gap
Implementation Method 3
integrated chemical entities like luminogenic, fluorogenic, and chemiluminescent substrates
Implementation Method 4
integrated chemical entities like luminogenic, fluorogenic, and chemiluminescent substrates
Data Source
AI summary
Devices with lateral flow elements and integral fluidics are disclosed. The integral fluidics consist of injector pumps comprised of fluidic elements under instrument control. The fluidic element of an injector pump is fluidically connected to lateral flow elements and can be used to control fluid entry into containment chambers referred to as micro-reactors. The lateral flow elements comprise conductor elements that can be used for sample application and transport of analyte contained in the sample to the micro-reactor. Fluidic transport through the fluidic element of the injector pump is under instrument-control. Both the lateral flow element and the fluidic element may contain chemical entities incorporated along their length. The chemical reactions that can be used for analyte detection using the devices are described. Also described are methods of manufacture of these devices.