Integrated Fluid Transfer for Rapid Contamination-Reduced Assays
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Solution Overview
Problem
Existing diagnostic technologies for bodily fluids are prone to contamination, require extensive time for results, and are unsuitable for rapid diagnosis, especially in conditions like sepsis where timely treatment is critical.
Innovation Solution
A fluid transfer device with an integrated flow-based assay system, such as a lateral flow assay, that allows for rapid diagnostic testing by sequestering an initial bodily fluid volume to reduce contamination and providing immediate results, coupled with a system that transitions between states to facilitate sample processing and analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If advanced diagnostic technologies (microbial detection, molecular diagnostics, genetic sequencing) are used to improve sensitivity and specificity, then measurement precision is improved, but the time required for testing increases to 6 hours to 5 days or more
Solution Approach 1:
The device segments the testing process into two independent pathways: (1) a rapid flow-based assay pathway that provides immediate results for rapid-acting antibiotics, and (2) a traditional culture pathway that continues in parallel for comprehensive pathogen identification. This segmentation allows the system to deliver actionable results within minutes while maintaining the option for extended diagnostic workup.
Solution Approach 2:
The device performs preliminary diagnostic testing using flow-based assays immediately upon sample collection, before the results of traditional culture methods are available. This preliminary action enables clinicians to initiate appropriate antibiotic therapy without waiting for definitive culture results, particularly for time-critical conditions like sepsis.
2Reliability
If traditional culture methods are used to reduce contamination, then reliability is improved, but the testing time increases to 6 hours to 5 days or more
Solution Approach 1:
The device segments the testing process into two independent pathways: (1) a rapid flow-based assay pathway that provides immediate results for rapid-acting antibiotics, and (2) a traditional culture pathway that continues in parallel for comprehensive pathogen identification. This segmentation allows the system to deliver actionable results within minutes while maintaining the option for extended diagnostic workup.
Solution Approach 2:
The flow-based assay acts as an intermediary testing method that bridges the gap between immediate clinical decision-making needs and the slower but more reliable traditional culture methods. It provides preliminary results that guide initial treatment while the culture results refine the diagnostic picture later.
3Measurement precision
If initial bodily fluid volume is sequestered to reduce contamination, then purity is improved, but device complexity increases due to multiple chambers and state transitions
Solution Approach 1:
The device is segmented into distinct functional chambers (sequestration chamber, flow-based assay chamber, culture chamber) that perform specific tasks in sequence. This segmentation allows each chamber to be optimized for its specific function while maintaining overall system manageability through clear functional boundaries.
Solution Approach 2:
The device employs dynamic state transitions between different operational modes (first state for sequestration, second state for flow-based assay, third state for culture). Valves and flow controllers enable the system to transition between these states, allowing a single device to perform multiple functions without requiring separate static structures for each function.
4Productivity
If rapid diagnostic testing is implemented for conditions like sepsis, then productivity is improved through faster treatment decisions, but the need for highly trained personnel and specialized protocols increases device complexity
Solution Approach 1:
The flow-based assay portion of the device is designed to be self-contained and self-explanatory, with built-in controls and clear result interpretation guidelines. This self-service design reduces the burden on operators, allowing rapid diagnostic testing to be performed with minimal specialized training while maintaining high diagnostic speed.
Solution Approach 2:
The device merges the rapid flow-based assay functionality with the traditional culture system into a single integrated platform. This combination allows the system to leverage existing infrastructure and protocols for culture while adding rapid testing capability, thereby increasing productivity without proportionally increasing operational complexity.
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, accurate, and contamination-reduced diagnostic testing at the point of care, allowing for timely treatment decisions based on initial test results, particularly for conditions like sepsis.
Implementation Method 1
flow-based assay system such as, for example, a lateral flow assay
Data Source
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Figure 5A~5B
AI summary
A system includes a fluid transfer device and a lateral flow assay device. The fluid transfer device has an inlet fluidically coupleable to a bodily fluid source, an outlet fluidically coupleable to a sample reservoir, and a sequestration chamber configured to receive an initial volume of bodily fluid. The fluid transfer device can be transitioned between (1) a first state with the sequestration chamber in fluid communication with the inlet to receive the initial volume, (2) a second state with the outlet in fluid communication with the inlet to receive a subsequent flow of bodily fluid, and (3) a third state with the lateral flow assay device in fluid communication with the sequestration chamber to receive a portion of the initial volume of bodily fluid. The lateral flow assay device configured to provide an indication associated with a presence of a target analyte in the bodily fluid.