Biological Sample Analysis via Custom Protocols and Cartridge Validation
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Solution Overview
Problem
Existing fully automated diagnostic analytical systems lack the flexibility to accommodate custom assays, limiting their use in scenarios such as detecting emerging epidemics or research studies.
Innovation Solution
An analysis system that allows for the creation and implementation of custom analysis protocols by using a controller to validate and modify identifiers on cartridges, enabling the use of custom reagents and protocols through a protocol creation system and identification units.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fully automated diagnostic analytical systems use validated assays and workflows, then reliability is improved, but adaptability deteriorates
Solution Approach 1:
The system dynamically adjusts between validated and custom assay modes. The controller can switch between executing pre-validates protocols and user-defined custom protocols based on the cartridge identifier type, allowing the system to maintain reliability for routine tests while adapting to custom research or outbreak investigation needs
Solution Approach 2:
The system changes the operational parameters by accepting different identifier types (validated vs. custom). When a custom identifier is detected, the system transitions from validated assay parameters to custom protocol parameters, enabling flexibility without compromising the integrity of validated testing pathways
2Adaptability or versatility
If the system accepts custom cartridges with custom identifiers, then adaptability is improved, but device complexity increases
Solution Approach 1:
The identifier validation system serves multiple functions: it validates traditional validated assay identifiers, accepts custom cartridge identifiers, and routes to appropriate processing modes. This multi-functionality allows the system to handle both validated and custom cartridges through a single unified interface, adding adaptability without proportionally increasing complexity
Solution Approach 2:
The controller acts as an intermediary between the identifier detection mechanism and the assay execution engine. It mediates by interpreting different identifier types and translating them into appropriate processing workflows, thereby simplifying the overall system architecture while enabling custom cartridge support
3Adaptability or versatility
If the system allows custom protocol creation and transfer, then adaptability is improved, but ease of operation deteriorates
Solution Approach 1:
The system enables end-users to independently create, configure, and transfer custom analysis protocols without requiring manufacturer intervention or complex setup procedures. Users can define their own assay parameters and directly load them onto cartridges, making the system self-sufficient for custom testing needs while maintaining ease of operation through intuitive user interfaces
Data Source
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AI summary
The invention provides for a method of analyzing a biological sample (108) in a fully automated and validated analysis system (100, 300, 400) comprising an analyzer (102) with an analytical unit (106) for analyzing the biological sample to obtain an analysis result (140). The analyzer is configured for receiving a cartridge (110) comprising an identifier (114) and containing at least one reagent for analyzing the biological sample. The analyzer comprises an identification unit (116) for reading the identifier. The analysis system further comprises a protocol creation system (150, 104). Instructions cause the protocol creation system to: receive (200) analysis protocol parameters (164) from a user interface (158); generate (202) a custom analysis protocol (138) using the analysis protocol parameters; link (204) the custom analysis protocol to an invalid identifier which changes the invalid identifier into a valid identifier, and transfer (206) the user created analysis protocol associated with the now valid identifier to the analyzer controller.