Automated Cell Enrichment System Error Recovery
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Solution Overview
Problem
Current methods for isolating rare cells from body fluids are labor-intensive, prone to variability due to manual processes, and require complex robotic systems, leading to errors and inefficiencies in sample preparation for clinical diagnostics.
Innovation Solution
An automated sample processing system, AutoPrep, that uses computer-controlled fluidic and motion control systems, error detection, and recovery mechanisms to enrich circulating cells, eliminating manual intervention and reducing assay variability by assessing inventory, performing precise plasma aspiration, magnetic separation, and cell staining, and transferring enriched cells to an analysis cartridge.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual cell enrichment techniques are used, then flexibility and adaptability are maintained, but operator variability and error rates increase
Solution Approach 1:
The system performs self-checks at multiple stages including reagent inventory assessment, sample processing verification, and error detection/recovery without operator intervention. The automated error detection and recovery mechanisms enable the system to self-correct or self-report issues, eliminating operator variability while maintaining high reliability through consistent automated execution of cell enrichment protocols
Solution Approach 2:
The system incorporates feedback mechanisms through error detection and recovery processes that monitor each step of the automated cell enrichment workflow. This feedback loop ensures assay consistency by automatically detecting deviations from protocol and implementing corrective actions, thereby maintaining reliability without requiring manual operator input
2Productivity
If complex robotic systems are implemented to automate sample processing, then productivity increases, but device complexity and cost increase
Solution Approach 1:
The automated system is divided into discrete functional modules including reagent inventory assessment, plasma aspiration, magnetic separation, and cell staining stations. Each module performs a specific function independently, allowing the system to achieve high throughput through automated sequencing of operations while managing complexity through modular design that can be controlled through software protocols
Solution Approach 2:
The automated device integrates multiple cell processing functions including enrichment, separation, washing, and staining into a single multi-functional platform. This universal system handles diverse sample types and protocols through programmable automation, increasing productivity while avoiding the need for multiple separate specialized devices
3Manufacturing precision
If centrifugation methods are used for cell separation, then separation efficiency is improved, but automation requires complex robotic handling
Solution Approach 1:
The system replaces mechanical centrifugation-based separation with magnetic field-based cell separation using magnetically labeled antibodies. This substitution eliminates the need for complex robotic centrifuge handling while maintaining high separation precision through automated magnetic bead-based enrichment protocols executed by the automated device
4Reliability
If manual wash steps with centrifugation are performed, then cell purity is improved, but sample loss and operator variability increase
Solution Approach 1:
The automated device performs self-monitored wash steps with magnetic separation that precisely control fluid handling volumes and timing. The system automatically detects and corrects potential errors, ensuring sample integrity is maintained while minimizing cell loss through precise automated aspiration and dispensing operations that eliminate manual handling variability
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
The system provides a rapid, standardized, and precise method for isolating rare cells, reducing operator errors and sample loss, and improving the integrity of samples for clinical analysis, enabling more reliable detection and enumeration of target cells for diseases like cancer.
Implementation Method 1
Magnetic separation of immuno-magnetically labeled target entities directly from the specimen
Implementation Method 2
Centrifugation, with or without density gradients, is a common method employed
Data Source
AI summary
The present invention provides a protocol and apparatus for enriching circulating tumor cells and other rare cells from blood, including debris and other components, from samples with high precision and at high throughput rates. This invention discloses an improved processing system from previously described semi-automated sample processing. The system further reduces operator intervention and hands-on time from prior systems. While this system has general utility in processing diverse materials, the system is configured for sample processing of biological specimens to provide an enriched fraction suitable for detection, enumeration and identification of target cells by appropriate analytical methodologies. The presence and quantities of such target cells in a sample specimen can utilized for screening and detection in disease such as cancer, assessing early stage pre-metastatic cancer, monitoring for disease remission in response to therapy and selection of more effective dose regimens or alternative therapies in case of relapse.