Multi-Chamber Nucleic Acid Testing With Isothermal Sample Dosing
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Solution Overview
Problem
Existing nucleic acid amplification technologies, such as PCR, require thermal cycling and sophisticated equipment, making them unsuitable for rapid, reliable, and cost-effective point-of-care diagnostics, while isothermal methods like RPA and LAMP face issues with non-specific amplification and high temperatures.
Innovation Solution
A portable detection device with multiple detection chambers, light sources, optical sensors, and a controller for isothermal recombinase polymerase amplification (RPA), using target-specific probes and enzymes, and a system for easy sample lysing and distribution, enabling simultaneous testing for different nucleic acids without complex setup.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If PCR is used for nucleic acid amplification, then sensitivity and specificity are improved, but device complexity and requirement for sophisticated equipment increase
Solution Approach 1:
The patent changes the temperature parameter from cyclic variation (PCR) to constant isothermal condition (37-42°C), enabling simplification of heating equipment while maintaining amplification capability. This parameter change allows the system to achieve reliable detection without complex thermal cycling equipment.
Solution Approach 2:
The patent replaces the mechanical thermal cycling system with a simple isothermal heating system. By substituting the complex temperature cycling mechanism with a constant temperature maintenance system, the device complexity is reduced while preserving detection reliability through the use of isothermal nucleic acid amplification.
2Productivity
If thermal cycling is used in PCR, then nucleic acid amplification is achieved, but time consumption and energy usage increase
Solution Approach 1:
The patent changes the temperature parameter from cyclic variation to constant isothermal condition, eliminating the time required for repeated heating and cooling cycles. This parameter change enables faster amplification by maintaining a constant optimal temperature for enzyme activity throughout the reaction process.
Solution Approach 2:
The patent implements continuous isothermal amplification without interruption for thermal cycling. The useful action of nucleic acid synthesis continues uninterrupted at constant temperature, eliminating idle time during temperature transitions and thereby reducing total testing time.
3Device complexity
If isothermal methods like LAMP are used, then equipment simplicity is improved, but temperature requirement increases to 65°C
Solution Approach 1:
The patent changes the temperature parameter to a lower isothermal range (37-42°C) compared to LAMP (65°C), making the device more suitable for point-of-care applications. This parameter change maintains equipment simplicity while reducing the thermal load and energy consumption.
4Device complexity
If RPA is used for isothermal amplification, then equipment requirement is reduced, but non-specific amplification occurs
Solution Approach 1:
The patent introduces probe molecules as intermediaries that specifically bind to target sequences. These probes act as mediators between the amplification reaction and detection system, enabling specific detection of amplified products and eliminating non-specific amplification issues inherent in RPA.
Solution Approach 2:
The patent replaces reliance on purely enzymatic specificity with probe-based hybridization specificity. By substituting the mechanical/enzymatic amplification mechanism with a probe-mediated detection mechanism, the system achieves high specificity while maintaining simple isothermal equipment requirements.
5Productivity
If multiple targets are tested simultaneously, then diagnostic efficiency is improved, but sample distribution complexity increases
Solution Approach 1:
The patent segments the testing process into separate reaction chambers, each dedicated to a specific target. This segmentation allows simultaneous testing of multiple targets in parallel without complex sample distribution, as each chamber independently processes its assigned target using pre-loaded reagents.
Solution Approach 2:
The patent performs preliminary preparation of reaction mixtures in separate chambers before sample introduction. By pre-configuring each chamber with specific reagents and probes for particular targets, the system eliminates the need for complex real-time sample distribution during multi-target testing.
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
Facilitates fast, reliable, and customizable nucleic acid testing for multiple targets in various environments, reducing the need for specialized labs and personnel, with fail-safe results and minimal sample consumption.
Implementation Method 1
a light source (26) arranged and configured to illuminate the contents of the respective detection chamber (20) with light that can cause luminescence in a sample to be tested
Implementation Method 2
an optical sensor (24) arranged and configured to detect luminescence in the detection chamber (20)
Implementation Method 3
heating means (28) for maintaining a predetermined temperature in the detection chambers (20)
Implementation Method 4
a mixture of chemicals including target-specific probes and enzymes that can cause an amplification of nucleic acid in a sample
Data Source
AI summary
The invention relates to a test system, a detection device for simultaneous test of samples contained in different test containers and a test container assembly comprising a single lysing chamber and a dosing assembly that is selectively fluid connected to the lysing chamber and that comprises a plurality of dosing compartments for dosed and simultaneous transfer of equal portions of a lysed sample from the lysing chamber into test vials.