Customizable Molecular Assay Software for Lab Developed Tests
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Solution Overview
Problem
Current molecular assay systems lack flexibility to perform user-defined assay protocols, limiting their ability to accommodate custom-developed Lab Developed Tests (LDTs) that require specific assay parameters.
Innovation Solution
A software tool and method that enable users to define and customize assay protocols by selecting user-defined assay parameters, allowing for the development and execution of LDTs on automated analyzers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the system performs IVD assays in batch mode with preloaded protocols, then system reliability and consistency are improved, but adaptability to custom LDT protocols deteriorates
Solution Approach 1:
The system transitions from static preloaded protocols to dynamic user-definable protocols. Users can now modify assay parameters, reagent volumes, thermal cycling conditions, and data analysis settings in real-time based on specific LDT requirements, while the system maintains operational reliability through structured protocol management.
Solution Approach 2:
The invention enables changing multiple assay parameters simultaneously including reagent volumes, incubation times, temperature profiles, and detection thresholds. This allows the same hardware platform to adapt to different LDT protocols by adjusting software-controlled parameters without physical modifications.
2Adaptability or versatility
If the system allows user-defined assay parameters for LDTs, then adaptability and versatility are improved, but device complexity increases
Solution Approach 1:
The protocol configuration is divided into modular sections: reagent parameters, thermal cycling conditions, data collection settings, and analysis parameters. Each section can be independently configured and validated, reducing the complexity burden on users while maintaining comprehensive customization capability.
Solution Approach 2:
A software interface acts as an intermediary between the user and the complex hardware system. This interface provides user-friendly controls for defining assay parameters, automatically translates user inputs into machine-executable protocols, and manages the complexity of coordinating multiple system components.
3Productivity
If batch mode processing is used for IVD assays, then productivity is improved, but loss of time occurs when switching between different assay types
Solution Approach 1:
The system uses a universal reagent introduction mechanism that can handle both IVD and LDT assays through the same fluid handling pathways. Reagent racks are designed with universal positioning, and the fluid transfer system can adapt to different reagent configurations, eliminating the need for separate introduction systems for different assay types.
Solution Approach 2:
The system pre-positions reagent racks and configures fluid transfer pathways before assay initiation. User-defined LDT protocols are pre-loaded with reagent locations and volumes, allowing the system to begin processing without delays when transitioning between different assay types.
4Adaptability or versatility
If custom LDT protocols are implemented, then adaptability is improved, but measurement precision may deteriorate due to user-defined parameters
Solution Approach 1:
The system incorporates validation feedback mechanisms that check user-defined parameters against acceptable ranges and best practices. The software provides real-time feedback on parameter configurations, warns of potential precision issues, and guides users toward optimized settings while maintaining the ability to perform custom LDTs.
Solution Approach 2:
The system includes pre-configured validation rules and parameter constraints that prevent obviously erroneous inputs before they can affect assay results. Default parameter sets provide a safety cushion, and the system can fall back to validated defaults if user inputs fall outside acceptable ranges, protecting against precision degradation.
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
This approach enhances the flexibility of molecular systems, enabling them to perform custom assay protocols and optimize assay results by allowing users to modify and refine assay parameters based on data review and analysis.
Implementation Method 1
PCR employs thermal cycling, which consists of repeated cycles of heating and cooling of a reaction mixture
Implementation Method 2
The growth of the amplicon may be detected using signal detecting devices (e.g., fluorescence detection devices) that measure signal emissions (e.g., level of fluorescence at a predetermined wavelength or range of wavelengths, etc.) indicative of the amplicon
Data Source
AI summary
A system for specifying user-defined assay parameters of a user-defined assay protocol for processing a sample includes a first graphical user interface for defining an analyte extraction parameter for an extraction process to extract a targeted analyte from the sample, a second graphical user interface for defining a target parameter specifying one or more channels of a multi-channel signal detector for detecting the targeted analyte, a third graphical user interface for defining parameters of a thermal profile specifying thermal conditions to which a reaction mixture is to be exposed to amplify the targeted analyte, and system-defined assay protocols pre-programmed into storage media and performed in accordance with system-defined assay parameters that are not changeable by a user and wherein at least one of the system-defined assay parameters is combined with the user-defined assay parameters to form the user-defined assay protocol.