Modular Molecular Diagnostic System for Nucleic Acid Processing
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Solution Overview
Problem
Current molecular diagnostics face challenges in flexibility and repeatability due to the complexities of nucleic acid isolation and amplification processes, which are influenced by the chemical properties and stability of DNA and RNA, and are prone to contamination risks.
Innovation Solution
An automated, random access system with an assay cartridge comprising a sample preparation module and a PCR module, detachably coupled, which includes a purification well with magnetic microparticles and reagent compartments, and a thermal cycler module for amplification, along with an optic module for fluorescence detection, allowing for flexible processing and minimal user intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual nucleic acid isolation and amplification processes are used, then user control and flexibility are maintained, but processing complexity increases and repeatability decreases
Solution Approach 1:
The system divides the molecular diagnostic process into distinct modular components: a sample preparation module for nucleic acid extraction and a PCR module for amplification. Each module can be independently optimized and operated, reducing overall process complexity while maintaining flexibility through modular assembly and detachable coupling.
2Measurement precision
If amplification is performed to increase sensitivity, then detection capability improves, but contamination risk increases
Solution Approach 1:
The system physically separates the amplification process into an isolated PCR module that is detachably coupled to the sample preparation module. This segmentation allows the amplification to occur in a controlled, isolated environment, reducing contamination risk while maintaining high detection sensitivity through proper thermal cycling conditions.
Solution Approach 2:
The system introduces an intermediary sealed reaction environment within the PCR module that mediates between the sample and the amplification reagents. This intermediary barrier prevents external contamination while allowing the amplification reaction to proceed with high sensitivity, and enables automated processing that minimizes user intervention.
3Stability of the object's composition
If different processing conditions are used for DNA and RNA isolation, then nucleic acid stability is improved, but system adaptability requirements increase
Solution Approach 1:
The system employs dynamic, adjustable processing conditions within the sample preparation module that can be modified based on the type of nucleic acid being processed. The modular design allows different protocols and reagent combinations to be used for DNA versus RNA isolation, maintaining optimal stability for each nucleic acid type while the automated system adapts to the specific requirements through programmable control.
4Object-affected harmful factors
If automated processing is implemented to reduce contamination, then user intervention is minimized, but device complexity increases
Solution Approach 1:
The automated system is divided into two main detachable modules: sample preparation and PCR amplification. This segmentation allows each module to be independently automated with appropriate level of complexity, reducing overall system complexity while maintaining automated processing that minimizes user intervention and contamination risk.
Solution Approach 2:
The system incorporates self-service features including automated sample processing, thermal cycling control, and detection capabilities within the modular architecture. The detachable modules can be independently operated and maintained, reducing the complexity burden on the user while achieving automated processing that minimizes contamination through reduced human contact.
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 system provides flexible and efficient processing of nucleic acid sequences with reduced contamination risks, enabling seamless integration into clinical workflows for accurate diagnostics without the need for extensive user intervention.
Implementation Method 1
the purification well contains magnetic microparticles capable of binding to nucleic acid
Implementation Method 2
a thermal cycler module for amplification
Implementation Method 3
an optic module for fluorescence detection
Data Source
AI summary
The present disclosure provides systems, devices and methods associates with processing and analyzing samples for molecular diagnostics. The system may process samples using assay cartridges including sample preparation modules and PCR modules. The system may include thermal cycler modules and optics modules to detect the specific nucleic acid sequences in the samples.