Microbiological Analysis Module for Reliable Rapid Testing After Enrichment
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Solution Overview
Problem
Current rapid assay analyzers for pathogen detection in food preparation facilities lack an enrichment step, leading to unreliable results due to the potential for high false positives and delayed reporting, as they do not ensure microorganism viability and require prolonged incubation periods.
Innovation Solution
A self-contained microbiological analysis system integrating a culture enrichment chamber and a microfluidic cartridge, enabling automated sample preparation and analysis, which includes a compliant culture enrichment chamber and a microfluidic cartridge with analysis chambers, reagent chambers, and a rotatable selector valve for fluid transfer, allowing for both enrichment and rapid testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If rapid assay analyzers are used without enrichment, then testing speed is improved, but detection reliability deteriorates due to high false positives and inability to ensure microorganism viability
Solution Approach 1:
The patent merges the enrichment step and rapid testing into a single integrated system. The microfluidic cartridge connects to the rapid assay analyzer, allowing the enriched sample to be directly analyzed. This combination ensures that the benefits of both enrichment (reliability, viability confirmation) and rapid testing (speed) are achieved simultaneously, resolving the contradiction between speed and reliability.
Solution Approach 2:
The enrichment step is performed as a preliminary action before rapid testing. By pre-enriching the sample in a controlled environment and confirming microorganism viability beforehand, the system ensures that the subsequent rapid assay starts with a reliable, enriched sample. This preliminary enrichment action eliminates the need to choose between speed and reliability, as both are achieved in sequence.
2Reliability
If traditional culturing methods are used, then detection reliability is improved, but time consumption increases to 24-72 hours or longer
Solution Approach 1:
The patent combines traditional enrichment culturing with modern rapid assay technology. The microfluidic cartridge enables controlled enrichment similar to traditional methods, ensuring reliability and viability confirmation. However, instead of requiring 24-72 hours for final analysis, the enriched sample is immediately analyzed using rapid assay techniques, reducing total time while maintaining the reliability benefits of enrichment.
Solution Approach 2:
The system enables continuous operation where enrichment and rapid testing occur in seamless succession without interruption. The microfluidic cartridge allows the enriched sample to be directly transferred and analyzed, eliminating idle time between enrichment and testing. This continuous workflow maintains the reliability advantages of traditional culturing while dramatically reducing the total time to results.
3Measurement precision
If off-site bacteriological laboratories are used, then detection accuracy is improved, but turnaround time increases due to transportation and wait times
Solution Approach 1:
The rapid assay analyzer with integrated enrichment is designed to be a multi-functional system that can perform both enrichment and rapid detection in one device. This eliminates the need to send samples to specialized off-site laboratories, as the system provides comparable or superior detection accuracy while keeping the entire process on-site. The universal capability of the device resolves the contradiction by making external laboratory services unnecessary.
Solution Approach 2:
The system is self-sufficient, performing both enrichment and rapid testing internally without requiring external laboratory services. The integrated design allows the device to handle the entire analytical process from sample preparation to results generation, eliminating transportation and external wait times while maintaining high detection accuracy through the combination of enrichment and rapid assay capabilities.
Data Source
AI summary
A microbiological analysis module and analysis station is disclosed. The microbiological analysis module comprises a culture enrichment chamber subassembly, insertable within an attachment collar. The attachment collar is attachable to a cartridge adapter. A microfluidic cartridge subassembly comprising a stage extending laterally from a receptacle. The stage comprises a channel manifold having one or more channels fluidically coupled to the culture enrichment chamber and to one or more analysis chambers, a prime chamber and reagent chambers. The chambers are integral with the channel manifold.