Automated Sample Processing Reagent Validation via Segmentation
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Solution Overview
Problem
Existing automated sample processing systems face challenges in validating new reagents and troubleshooting reagent performance, particularly when switching between reagent containers, due to difficulties in determining the exact switching point and inherent variations in tissue samples.
Innovation Solution
The implementation of a virtual split run mode in automated sample processing systems, which divides sample carriers and reagent containers into groups to perform validation and troubleshooting tasks, allowing for separate processing protocols and comparison of results to ensure reagent validity and identify potential issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated sample processing systems process samples using multiple reagent containers sequentially, then productivity is improved, but reliability deteriorates due to difficulty in determining the exact switching point and inherent variations in tissue samples
Solution Approach 1:
The system segments the sample carriers into different groups (e.g., first group, second group) and assigns different reagent containers to each group. This segmentation allows simultaneous processing of validation samples and routine samples using separate reagent containers, enabling clear determination of reagent switching points while maintaining high throughput.
Solution Approach 2:
The system performs preliminary validation processing by processing a first group of sample carriers with a first reagent container before processing the second group with a second reagent container. This preliminary action establishes baseline performance data and validates reagent performance before routine processing, ensuring reliability without interrupting overall productivity.
2Reliability
If the system processes all samples with a single reagent container, then reliability is maintained, but productivity decreases due to inability to efficiently validate new reagents
Solution Approach 1:
The system divides sample carriers into multiple groups that can be processed with different reagent containers. This allows the system to maintain reliable processing with known reagents while simultaneously validating new reagents on separate sample groups, eliminating the need to choose between reliability and validation efficiency.
Solution Approach 2:
The system design allows the same processing apparatus to perform multiple functions: routine sample processing with established reagents and validation processing with new reagents. The controller is configured to manage both validation protocols and routine protocols, making the system multi-functional and increasing productivity without compromising reliability.
3Reliability
If the system implements separate validation protocols for each reagent container, then reliability is improved, but device complexity increases
Solution Approach 1:
The controller is designed with multi-functionality to manage both validation protocols and routine processing protocols using the same hardware resources. This universal design allows the system to implement thorough validation for each reagent container while avoiding the complexity of separate dedicated validation systems, as the same processor handles both functions.
4Reliability
If the system uses control samples to validate reagents, then reliability is improved, but loss of time increases due to additional validation steps
Solution Approach 1:
The system performs validation using control samples as a preliminary action before routine processing begins. By validating reagents in advance on dedicated control samples, the system ensures reliability is established beforehand, and subsequent routine processing can proceed without time-consuming validation interruptions, thus minimizing overall time loss.
Data Source
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Figure 2a
AI summary
Method and apparatus for automatic sample processing including reagent validation are disclosed. The apparatus may include a reagent section, a slide section, a robotic element configured to perform sample processing operations, and a sample processing controller configured to control the robotic element according to a processing protocol. The method of performing automatic sample processing using an automatic sample processing apparatus that includes a plurality of sample carriers, a plurality of reagent containers, and a robotic processing element, may include designating at least one group from among the plurality of sample carriers as corresponding to at least one group from among the plurality of reagent containers according to a grouping plan and controlling the robotic processing element to perform processing steps according to a processing protocol on the at least one group of the plurality of sample carriers using reagents obtained from the corresponding at least one group of the plurality of reagent containers and not from a non-corresponding group of reagent containers.