Streamlined Assay Assembly for Pathogen Detection
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Solution Overview
Problem
Conventional methods for detecting pathogenic microorganisms are cumbersome, costly, and inefficient, requiring skilled technicians, lengthy processing times, and are not portable, making them unsuitable for rapid diagnosis and at-home testing, especially in resource-poor settings where accessibility and contamination risks are high.
Innovation Solution
A streamlined assay assembly that includes a single-use consumable sample collection tube and a reusable base unit, with integrated bi-stable locking mechanisms and a sample collector cap, allowing for simplified and cost-effective sample collection, assay preparation, and bubble-free puncturing, enabling rapid detection of pathogenic microorganisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional multi-step detection methods are used, then detection accuracy is maintained, but processing time is excessive and requires skilled technicians
Solution Approach 1:
The device is divided into distinct functional modules: a disposable sample collection tube with integrated reagents and a reusable base unit with heating and detection components. This segmentation allows the complex analytical functions to be concentrated in the reusable base while the disposable tube handles simple sample preparation, dramatically reducing the skill level needed for operation while maintaining detection capabilities.
Solution Approach 2:
Reagents are pre-loaded into the sample collection tube during manufacturing, and the device is designed to perform automated sample processing steps. This preliminary preparation eliminates the need for technicians to manually prepare samples and reagents during testing, reducing both processing time and skill requirements.
2Ease of operation
If disposable systems are used for at-home testing, then accessibility is improved, but auxiliary read-out systems become expensive and limit disposability
Solution Approach 1:
The system separates the disposable sample collection tube (containing all consumable reagents and sample processing components) from the reusable base unit (containing expensive electronics, heating elements, and detection systems). This allows the expensive read-out infrastructure to be shared across multiple disposable tubes, making at-home testing economically viable while maintaining full diagnostic capability.
Solution Approach 2:
The reusable base unit is designed to accommodate multiple different disposable sample collection tubes for various pathogen detections. This multi-functionality allows a single expensive base unit to serve multiple testing purposes over time, reducing the per-test cost and making the system economically sustainable for widespread deployment.
3Ease of manufacture
If low-cost manufacturing techniques are used, then device cost is reduced, but ability to shape fluidic chambers to prevent air bubbles is restricted
Solution Approach 1:
The fluidic system is segmented into the disposable sample collection tube (containing all complex fluidic channels and chambers) and the reusable base unit. The disposable tube can be manufactured using low-cost techniques like therm成型 or injection molding, while the complex fluidic geometry is confined to this single disposable component that is replaced after each use, eliminating the need for expensive precision manufacturing of the reusable base unit.
Solution Approach 2:
The sample collection tube is designed as a disposable component that contains all the complex fluidic chamber geometry needed for bubble-free operation. Since it is discarded after a single use, it can be manufactured using inexpensive molding techniques without requiring high-precision, expensive manufacturing processes. The reusable base unit has simpler fluidic interfaces that are easier and cheaper to manufacture with high precision.
Data Source
AI summary
The present disclosure provides assay and method for using assay for streamlined assay preparation and testing. These assay are useful for pathogen (e.g., viral or bacterial) detection. The present disclosure also provides assay assemblies and means to prevent or minimize the formation of bubbles when using puncturing elements in fluidic devices or chambers.