Automated Sample Analysis System with Continuous Operator Access
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Solution Overview
Problem
Current molecular analysis techniques, such as PCR, face challenges in efficient sample preparation and continuous operation without operator intervention, particularly in clinical settings where real-time analysis and detection of nucleic acids for diseases like cancer and infections require rapid and reliable methods.
Innovation Solution
An automated sample analysis system that integrates real-time PCR technology for nucleic acid preparation and analysis, allowing continuous operation with redundant components and 'lockstep' protocols for parallel processing of multiple assays, enabling continuous operator access for replenishment and waste removal without halting the system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated sample preparation and analysis is implemented, then productivity and speed of diagnosis are improved, but device complexity increases
Solution Approach 1:
The automated molecular analysis system is divided into distinct functional modules: sample preparation module, nucleic acid extraction module, PCR amplification module, and detection module. Each module operates independently with specialized components, allowing high-speed automated processing while managing complexity through modular design. This segmentation enables continuous operation and rapid diagnostics.
Solution Approach 2:
The automated system integrates multiple functions into a single platform: sample processing, nucleic acid extraction, PCR amplification, and fluorescent detection. This multi-functional integration improves productivity by eliminating manual transfer steps between separate instruments while the standardized module design manages overall system complexity.
2Measurement precision
If real-time PCR analysis is performed, then measurement precision and sensitivity are improved, but the time required for analysis increases
Solution Approach 1:
The system performs real-time PCR amplification and detection in a continuous process without interruption. The thermal cycler maintains continuous cycling through denaturation, annealing, and extension phases while the detection system continuously monitors fluorescent signals. This continuous operation achieves high detection sensitivity while completing the full analysis in approximately one hour or less, minimizing total analysis time.
Solution Approach 2:
The system combines PCR amplification and fluorescent probe detection in the same reaction vessel simultaneously. The amplification process and detection process occur concurrently rather than sequentially, allowing real-time monitoring of nucleic acid amplification. This merging of functions maintains high measurement precision and sensitivity while significantly reducing total analysis time compared to conventional sequential methods.
3Measurement precision
If conventional PCR with Southern blot analysis is used, then measurement precision is maintained, but the risk of contamination and loss of time increase
Solution Approach 1:
The system combines PCR amplification and fluorescent probe detection in the same closed reaction vessel. The fluorescent probes hybridize to amplified nucleic acids during the amplification process itself, allowing detection without opening the reaction vessel. This eliminates the need for post-PCR handling steps that would require vessel opening, thereby maintaining detection specificity while eliminating contamination risks associated with conventional Southern blot analysis.
Solution Approach 2:
The PCR reaction occurs in a closed, sterile reaction vessel that maintains an inert environment throughout the amplification and detection process. The fluorescent detection is performed through the vessel wall or lid without opening it, preventing exposure to external contaminants. This closed-system approach maintains measurement precision while eliminating contamination risks present in conventional open-system methods.
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
Enables rapid, sensitive, and specific analysis of nucleic acids, supporting continuous operation in clinical settings with reduced risk of contamination and improved efficiency in diagnosing diseases, including cancer and infectious agents.
Implementation Method 1
isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples
Implementation Method 2
fluorescent probe detection of amplified product
Data Source
AI summary
Aspects of the present disclosure include sample analysis methods and systems. According to certain embodiments, provided are methods of analyzing samples in an automated sample analysis system. The methods include introducing samples and sample preparation cartridges into the system, isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples at a sample preparation station, and performing analyte detection assays in assay mixtures that include the purified analyte. Also provided are automated sample analysis systems that find use, e.g., in performing the methods of the present disclosure. In certain aspects, the methods and systems provide for continuous operator access during replenishment or removal of one or any combination of samples, bulk fluids, reagents, commodities, waste, and/or the like.