Microbial Screening Assays for Statistical Process Control
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Solution Overview
Problem
Existing microbial detection schemes are prone to type-1 and type-2 errors, leading to unreliable presence/absence tests, and are not effectively applicable to statistical process control (SPC), particularly in environments with low or undetectable target microbe levels, limiting early warning and risk assessment in manufacturing processes.
Innovation Solution
The use of microbial markers shared by target and index microbes to generate an aggregate index value from multiple presence/absence tests, allowing for more accurate monitoring of microbial growth, contaminants, and performance potential, and enabling trend analysis and SPC in processes receptive to genetically distinct microbes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If presence/absence tests are used to detect target microbes, then detection simplicity is maintained, but reliability deteriorates due to type-1 and type-2 errors
Solution Approach 1:
The patent combines multiple presence/absence tests for different marker genes (e.g., rfb, eae, stx1, stx2, hly) into an integrated diagnostic system. By merging the results of these individual tests, the system achieves higher reliability in detecting target microbes while maintaining the simplicity of presence/absence test format. The combined approach reduces false positives and false negatives that occur with single-marker tests.
2Device complexity
If single-marker presence/absence tests are used, then test complexity is reduced, but measurement precision deteriorates due to inability to provide quantitative trend data
Solution Approach 1:
The patent transitions from single-dimensional presence/absence data to multi-dimensional profiling by testing multiple marker genes simultaneously. This dimensional expansion allows the system to generate composite scores and trend data that provide quantitative measurement precision while maintaining relatively simple test procedures. The multi-marker profile approach creates a more nuanced detection capability without proportionally increasing test complexity.
3Ease of operation
If traditional presence/absence detection schemes are used, then ease of operation is maintained, but applicability to statistical process control deteriorates due to lack of trend information
Solution Approach 1:
The patent creates a multi-functional detection system that serves both simple detection purposes and statistical process control requirements. The same multi-marker presence/absence test platform generates data suitable for both immediate diagnostic interpretation and longitudinal trend analysis. This universal approach allows the system to adapt to different operational needs without requiring separate testing protocols.
4Reliability
If multiple marker genes are tested simultaneously, then detection reliability is improved, but device complexity increases
Solution Approach 1:
The patent segments the detection task into multiple independent marker gene tests that can be performed in parallel. Each marker gene (rfb, eae, stx1, stx2, hly) is tested separately using standardized presence/absence methods, then the results are integrated. This segmentation approach maintains the simplicity and reliability of individual tests while achieving comprehensive detection through combination, avoiding the need for complex single-step multi-detection systems.
Data Source
AI summary
Aspects of the present invention provide novel multi-targeted microbiological screening and monitoring methods having substantial utility for monitoring and control of microbial growth and contaminants, microbiological processes, predictive microbiology, and for exposure and risk assessment. Microbial markers shared by both target and index microbes are used in novel methods for microbial monitoring, monitoring of microbial performance potential, trend analysis, and statistical process control (SPC) in processes or systems that are receptive to a plurality of genetically distinct microbes.