Lateral Flow Nucleic Acid Device with Waste Diversion Valve
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Solution Overview
Problem
Current nucleic acid amplification and detection techniques face challenges due to inhibitory components in biological samples, which can degrade amplification and detection reagents, reducing sensitivity and requiring complex wash steps to remove contaminants.
Innovation Solution
A lateral flow sample assessment device with a substrate containing lysis, amplification, and waste regions, utilizing a valve to separate and divert waste products from amplification products, allowing for simultaneous amplification and detection without manual washing, using a porous substrate for efficient nucleic acid amplification and detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If wash steps are added to remove lysis reagents and waste products, then sensitivity and detection accuracy are improved, but device complexity and user intervention requirements increase
Solution Approach 1:
The device is divided into distinct functional regions: a lysis region for sample preparation, an amplification region for nucleic acid amplification, and a detection region for signal generation. This spatial segmentation allows waste products to be physically separated from the detection zone, enabling accurate detection without complex wash steps.
Solution Approach 2:
Waste products and lysis reagents are extracted and directed to a waste collection region separate from the amplification and detection regions. This extraction prevents contaminants from interfering with detection while maintaining a simple single-step user operation.
2Measurement precision
If manual wash steps are required to remove contaminants, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The device performs self-cleaning through its internal fluidic design. As sample fluid flows through the device, waste products are automatically directed to the waste collection region by capillary forces and pressure gradients, eliminating the need for user-performed wash steps while maintaining high sensitivity.
3Productivity
If lysis reagents are present in the amplified sample, then cell lysis is effective, but harmful factors increase due to degradation of amplification reagents
Solution Approach 1:
The device separates the lysis function from the amplification function by creating distinct lysis and amplification regions. This allows aggressive lysis reagents to be concentrated in the lysis region where they are needed, while the amplification region contains only the reagents required for nucleic acid amplification, preventing degradation and maintaining both lysis efficiency and amplification integrity.
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 faster, more convenient nucleic acid amplification and detection with reduced contaminant interference, allowing for point-of-care testing without the need for additional wash steps, improving sensitivity and workflow efficiency.
Implementation Method 1
a porous substrate for efficient nucleic acid amplification and detection
Implementation Method 2
an amplification region capable of being heated to a temperature range sufficient for nucleic acid amplification
Data Source
AI summary
The present disclosure relates to a sample assessment device. By way of example, the sample assessment device may include a substrate including a sample application region; an amplification region comprising a plurality of amplification reagents; a waste region comprising an entrance fluidically coupled to the amplification region and extending away from the amplification region; and a detection region spaced apart from the amplification region. The sample assessment device may also include a valve coupled to the substrate and configured to separate the amplification region from the detection region in a closed configuration, wherein the amplification region and the valve are positioned on the sample assessment device between the sample application region and the detection region and wherein the sample assessment device is configured to permit lateral flow from the amplification region to the detection region when the valve is in an open configuration.