Fluid Transfer Assay Integration for Low-Contamination Diagnosis
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Solution Overview
Problem
Existing diagnostic technologies for bodily fluids are prone to contamination, require trained personnel, and take too long to yield results, making them unsuitable for rapid diagnosis of conditions like sepsis, which can progress rapidly and require immediate treatment.
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, while also allowing for subsequent sampling for more sensitive tests.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If rapid diagnostic testing is implemented, then diagnostic speed is improved, but accuracy and reliability deteriorate due to contamination risks
Solution Approach 1:
The device divides the fluid sampling process into distinct segments: an initial sequestration phase where the first volume of fluid is isolated in a sequestration chamber, and a subsequent sampling phase where a second volume is collected for testing. This segmentation allows the first volume (which may contain contaminants) to be separated from the second volume (used for accurate testing), thereby maintaining both rapid testing capability and test accuracy.
Solution Approach 2:
The device performs a preliminary action by sequestering the first volume of bodily fluid in the sequestration chamber before the actual diagnostic testing occurs. This preliminary sequestration step prepares the system by removing potential contaminants in advance, ensuring that subsequent rapid tests are performed on clean samples, thus maintaining both speed and reliability.
2Measurement precision
If advanced diagnostic technologies are used, then measurement precision is improved, but device complexity increases requiring trained personnel
Solution Approach 1:
The device merges multiple functions into a single integrated system: fluid sequestration, fluid transfer, and diagnostic testing are combined in one device. The sequestration chamber, transfer mechanism, and testing interface work together as a unified system, eliminating the need for separate complex equipment and reducing the requirement for highly trained personnel while maintaining diagnostic precision.
Solution Approach 2:
The device provides self-service capabilities by automatically managing the fluid sequestration and transfer processes. The system performs preliminary fluid handling operations without requiring manual intervention or complex operational procedures, making advanced diagnostic capabilities accessible to users with minimal training while maintaining high measurement precision.
3Reliability
If initial fluid volume is sequestered to reduce contamination, then sample purity is improved, but time required for testing increases
Solution Approach 1:
The sequestration of the first fluid volume is performed as a preliminary action that occurs rapidly during the initial phase of sample collection. By establishing the sequestration chamber connection and transferring the first volume in advance, the system prepares pure samples for subsequent testing without adding significant time to the overall diagnostic process, thus maintaining both sample purity and testing speed.
Solution Approach 2:
The device maintains continuity of useful action by seamlessly transitioning from the sequestration phase to the testing phase. The second volume of fluid is continuously transferred from the sequestration chamber to the testing interface without interruption or additional setup time, ensuring that the purity benefits of sequestration are achieved without sacrificing diagnostic speed.
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 point-of-care diagnostic testing with reduced contamination, enabling timely treatment decisions and integration with additional testing methods for improved patient outcomes.
Implementation Method 1
a flow-based assay device configured to be coupled to the port to receive a portion of the first volume of bodily fluid and provide an indication associated with the presence of a target analyte in the portion of the first volume of bodily fluid
Data Source
Figure 1~2
Figure 3~4
Figure 5A~5B
AI summary
A system comprises a fluid transfer device (305) including a housing, the housing forming an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a sample reservoir, the housing including a sequestration chamber and a port in fluid communication with the sequestration chamber, the sequestration chamber configured to be placed in fluid communication with the inlet via a first flow path to receive a first volume of bodily fluid when the fluid transfer device is in a first state, the outlet configured to be placed in fluid communication with the inlet via a second flow path to receive a second volume of bodily fluid when the fluid transfer device is in a second state; and a flow-based assay device coupleable to the port to receive a portion of the first volume of bodily fluid via a third flow path when the fluid transfer device is in a third state, the flow-based assay device configured to provide an indication associated with the presence of a target analyte in the portion of the first volume of bodily fluid.