Molecular Diagnostic Assay Components with Configurable Analysis Modules
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Solution Overview
Problem
Existing molecular diagnostic methods face challenges in efficiently deploying and managing processing/analysis modules and parameter values due to the need for hard-coded software updates for each change in target nucleic acid detection, making it inconvenient to add new parameters or modify operations.
Innovation Solution
A method and device for generating an assay component that includes processing/analysis modules and parameter values, which are generated based on molecular diagnostic amplification data and can be distributed to target presence/absence determining software, allowing for flexible and efficient deployment and management of these components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If hard-coded software is used for determining target presence/absence, then the software structure is simple and reliable, but any changes to parameters or modules require individual software updates and redeployment
Solution Approach 1:
The patent segments the determining module into separate, independent modules that can be individually selected and configured. Each module performs a specific function in the data processing chain (e.g., baseline subtraction, derivative calculation, threshold determination), allowing them to be modified, added, or removed without affecting the entire software system. This modular architecture enables flexible adaptation while maintaining system stability.
Solution Approach 2:
The patent implements dynamic configuration of determining modules and parameters through executable instructions that can be loaded and executed based on specific assay requirements. The system allows runtime selection of modules and parameters rather than fixed hard-coding, enabling the software to adapt to different molecular diagnostic assays without requiring full software updates. This dynamic approach resolves the contradiction by making the system flexible while maintaining a stable core infrastructure.
2Ease of operation
If hard-coded determining modules and parameter values are used, then the software is easier to manage, but adding new parameters or changing operation orders requires individual software reflection and new version deployment
Solution Approach 1:
The patent prepares determining modules and parameter configurations in advance as separate executable components that can be quickly deployed. The modular design allows new parameters and modules to be pre-configured and validated independently, then integrated into the system without requiring full software redevelopment. This preliminary preparation of modular components significantly reduces the time needed to implement changes while maintaining ease of operation.
Solution Approach 2:
The patent uses template-based configurations and reusable determining module patterns that can be copied and adapted for different assays. Instead of creating custom software for each new parameter or module, the system replicates and configures standardized modular components, dramatically reducing the time and effort required for software updates and deployments while maintaining ease of operation.
3Adaptability or versatility
If multiple determining modules are used for different target nucleic acid molecules, then the detection capability is enhanced, but the types and execution orders of functions vary depending on target characteristics
Solution Approach 1:
The patent designs determining modules with universal interfaces and standardized configuration formats that can handle different target nucleic acid molecules. Each module is built to be multi-functional, capable of adapting to various assay types and target characteristics through configuration parameters rather than requiring completely different module implementations. This universal design enables enhanced detection capability across multiple targets while controlling complexity through standardized module architecture.
Data Source
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AI summary
A method for generating a component for an assay, the method comprising: acquiring molecular diagnostic amplification data generated by using a molecular diagnostic assay for a plurality of target nucleic acid molecules; and generating the component for the assay based at least partially on the molecular diagnostic amplification data, wherein the component for the assay includes: a processing/analysis module including sub-modules for processing and analyzing, in the target presence/absence determining software, the molecular diagnostic amplification data for the plurality of target nucleic acid molecules; and a parameter value referenced by the sub-modules, and wherein a sub-module predefined to be called for the processing and analyzing the molecular diagnostic amplification data among the sub-modules processes and analyzes the molecular diagnostic amplification data for the plurality of target nucleic acid molecules by referencing the parameter value in response to a request of the target presence/absence determining software.