Nucleic Acid Amplification Device With Internal Venting
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Solution Overview
Problem
Current genetic testing devices face issues with environmental contamination, false positives due to carry-over contamination, and user error, particularly in rapid diagnostic tests that lack effective sealing and are incompatible with genetic assays, limiting accessibility to central laboratories.
Innovation Solution
A testing device with a fluid management layer, internal vents, and a multi-layered layout that includes a sample port, assay strip, nucleic acid amplification pad, reagent labeling pad, and detection pad, along with a valve system and heating elements, to manage fluid flow, prevent contamination, and ensure accurate amplification and detection of nucleic acids without the need for instrumentation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If rapid diagnostic tests use open porous materials to draw fluids by capillary action, then fluid transport is achieved, but environmental contamination and carry-over contamination occur
Solution Approach 1:
The device is divided into separate sealed zones (reagent reservoir, reaction chamber, detection zone) connected by controlled fluid paths. This segmentation prevents open porous materials from contacting the environment while maintaining capillary-driven fluid transport between enclosed compartments.
Solution Approach 2:
Sealing membranes and flexible seals are used to close the porous materials and fluid paths, creating a sealed system that prevents contamination while allowing controlled fluid flow through the assay components.
2Reliability
If sealed tubes are used for nucleic acid amplification, then carry-over contamination is reduced, but user error increases and accessibility to central laboratories is required
Solution Approach 1:
The device uses self-contained sealed reservoirs with pre-loaded reagents and automated fluid management through capillary action and pressure equalization vents, eliminating the need for user handling of sealed tubes and reducing user error while maintaining contamination prevention.
Solution Approach 2:
Reagents are pre-prepared and sealed in the device before use, with fluid paths and valves pre-configured for the assay sequence, eliminating the need for users to manually assemble or handle sealed tubes during the test.
3Productivity
If internal vents are added to prevent pressure buildup, then fluid flow is improved, but device complexity increases
Solution Approach 1:
Pressure equalization vents are extracted as simple passive air channels that allow pressure balancing without requiring active control mechanisms, maintaining fluid flow while minimizing added complexity.
Solution Approach 2:
The vents act as intermediary elements that mediate pressure differences between sealed zones, enabling smooth fluid flow through the device without requiring complex pressure control systems.
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 effectively prevents carry-over contamination and evaporation, enabling accurate and accessible genetic testing in a self-contained format, reducing user error and increasing accessibility beyond central laboratories.
Implementation Method 1
a first internal vent having a first vent inlet, a first vent outlet, and a first venting channel connecting the first vent inlet to the first vent outlet, wherein the first vent inlet is arranged at a first location in the fluid management body along the fluid path downstream of the valve, and the first vent outlet is at a second location in the fluid management body upstream of the valve
Implementation Method 2
the testing device comprises a heating layer adjacent to the fluid management layer
Implementation Method 3
as their materials draw fluids forward by capillary action
Data Source
AI summary
Methods, apparatuses, and testing devices comprising a fluid management layer including a fluid management body, a sample port defined in the fluid management body, an assay strip encased in the fluid management body along a fluid path, a valve defined on the assay strip, and a first internal vent having a first vent inlet, a first vent outlet, and a first venting channel connecting the first vent inlet to the first vent outlet, wherein the first vent inlet is arranged at a first location in the fluid management body along the fluid path downstream of the valve, and the first vent outlet is at a second location in the fluid management body upstream of the valve.