Isothermal Test Plate for Automated Nucleic Acid Detection
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Solution Overview
Problem
Current diagnostic methods for detecting infectious microorganisms and other biological markers, such as PCR tests, are lengthy and costly due to the need for temperature cycles, and there is a need for a system that can process multiple samples quickly and reliably using isothermal methods like LAMP or RT-LAMP.
Innovation Solution
A test plate with isolated channels and housings for sample processing, including an extraction membrane, reaction zones with lyophilized reagents, and a recovery reservoir, designed for automated processing without manual intervention, allowing for isothermal nucleic acid amplification and detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If PCR tests are used for diagnostic detection, then detection accuracy is improved, but test duration and cost increase significantly
Solution Approach 1:
The patent changes the temperature parameter from cyclic variation (PCR) to constant isothermal condition (LAMP), eliminating the need for thermal cycling while maintaining detection accuracy. This parameter change reduces test duration significantly while preserving the ability to detect nucleic acid sequences with high precision
Solution Approach 2:
The patent replaces the mechanical thermal cycling system with an isothermal amplification system that uses constant temperature conditions. This substitution eliminates complex temperature control mechanisms while achieving reliable nucleic acid detection through enzymatic amplification at a single temperature
2Ease of operation
If manual processing steps are used in test systems, then flexibility is improved, but reliability and speed decrease
Solution Approach 1:
The test plate is designed to perform extraction, purification, and amplification steps automatically through integrated channels and reagent compartments. The system guides the liquid flow and reagent mixing autonomously, eliminating manual intervention while ensuring consistent, reliable results across multiple samples
Solution Approach 2:
The patent combines multiple separate processing steps (sample extraction, nucleic acid purification, and amplification) into a single integrated test plate. This merging of functions into one automated system improves reliability by eliminating manual transfer steps and increases processing speed through continuous automated operation
3Productivity
If thermal cyclers are used for PCR amplification, then amplification efficiency is improved, but device complexity and cost increase
Solution Approach 1:
The patent extracts the amplification reaction from the complex thermal cycler environment and places it in a simple isothermal setting. By taking out the temperature cycling requirement and using constant temperature LAMP amplification, the system achieves high productivity with minimal device complexity, suitable for point-of-care settings
Solution Approach 2:
The patent employs disposable test plates with pre-loaded reagents and integrated reaction chambers. This approach eliminates the need for expensive, complex thermal cyclers by using single-use plates that perform isothermal amplification, reducing device complexity while maintaining amplification efficiency for each test
4Adaptability or versatility
If multiple samples are processed manually, then customization is improved, but processing speed and consistency decrease
Solution Approach 1:
The patent uses individual test plates for each sample, with each plate being a self-contained processing unit. This segmentation allows multiple samples to be processed in parallel, dramatically increasing processing speed while maintaining the ability to customize each test according to specific sample requirements through the standardized plate 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 rapid, reliable, and cost-effective processing of multiple samples by automating the nucleic acid amplification and detection process, ensuring accurate results without the need for temperature cycles, and allowing for easy integration with existing analysis stations.
Implementation Method 1
an extraction membrane, arranged in a first housing... the test plate being configured to feed the biological sample to be tested into the extraction membrane
Implementation Method 2
a first reaction zone containing a porous media arranged in a second housing and containing a first test reaction mixture in lyophilized form
Data Source
AI summary
A single-use test plate in a biological test system for determining the presence of one or more nucleic acid sequences, the test plate including a body having channels and sockets formed therein, an inlet for receiving a test sample, an air inlet, an extraction membrane, reaction zones containing a porous media with first and second reaction mixtures allowing amplification and detection of the nucleic acid species, an air outlet, a recovery reservoir, the plate being configured to feed the biological sample to be tested into the extraction membrane, then after rinsing, drying and elution of said extraction membrane, to feed the resulting eluate into the reaction zones, in order, after reaction, to deduce therefrom a result through the readout zone.