Integrated Fluid Testing Module for Rapid Hemolysis Detection
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Solution Overview
Problem
Existing point-of-care testing devices do not have mechanisms for rapidly testing fluid samples, such as blood, to determine hemolysis before introducing them into analyzers, leading to interference and inaccurate results due to residual broken blood cells.
Innovation Solution
A fluid testing device with a fluid treatment module that includes a lateral flow strip or membrane for separating constituents, allowing for on-site hemolysis detection and analysis of fluid samples, seamlessly integrating with testing instruments for further assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a centrifuge is used to spin down blood samples for qualitative hemolysis assessment, then hemolysis can be determined, but the process is time-consuming and not suitable for rapid point-of-care testing
Solution Approach 1:
The device segments the blood sample analysis into two separate chambers: a first chamber for whole blood analysis and a second chamber for plasma analysis. This segmentation allows parallel processing of different sample types, enabling rapid hemolysis assessment without requiring sequential centrifugation steps, thus reducing testing time while maintaining accuracy.
Solution Approach 2:
The device performs preliminary separation of plasma from whole blood using capillary action through a porous membrane before analysis. This preliminary action eliminates the need for time-consuming centrifugation at the point of care, allowing rapid hemolysis detection to be performed directly on separated plasma while preserving the integrity of the original sample for further testing.
2Measurement precision
If Drabkin's Reagent is used to determine Hb levels, then intracellular and free hemoglobin can be measured, but it does not provide an accurate picture of free Hb present at a particular point in time
Solution Approach 1:
The device extracts and separates plasma from whole blood using capillary action through a porous membrane. By taking out the plasma component containing free hemoglobin for separate analysis, the device enables accurate measurement of free Hb concentration at the specific point in time, eliminating the interference from intracellular hemoglobin that plagues Drabkin's Reagent methodology.
Solution Approach 2:
The porous membrane acts as an intermediary that selectively allows plasma to pass through while retaining whole blood components. This intermediary separation enables the use of simple colorimetric methods to accurately measure free hemoglobin in plasma without the need for complex reagents like Drabkin's, thereby preserving temporal accuracy of free Hb concentration measurements.
3Reliability
If a sampler cap is used to de-aerate and seal blood samples, then leakage is prevented, but no mechanism exists for testing the sample before analyzer introduction
Solution Approach 1:
The sampler cap device integrates multiple functions into a single unit: it seals the sample to prevent leakage, de-aerates the blood sample, separates plasma from whole blood, and provides testing chambers for both whole blood and plasma analysis. This multi-functionality enables comprehensive sample assessment at the point of care while maintaining sample integrity for subsequent analyzer testing.
Solution Approach 2:
The device merges the sealing, de-aeration, separation, and testing functions into a single integrated sampler cap assembly. By combining these previously separate operations into one device, the system enables rapid on-site hemolysis testing without compromising sample sealing or requiring additional equipment, thereby enhancing versatility while maintaining reliability.
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 and accurate determination of hemolysis in fluid samples, ensuring accurate test results and preventing interference, while allowing seamless transition to further testing without disrupting the standard workflow.
Implementation Method 1
a porous membrane that separates plasma from the whole blood
Data Source
AI summary
A device including a housing, a zone and a means for testing a fluid sample within the housing is disclosed. The housing is constructed of a fluid impermeable material, and defines a first fluid port, and a second fluid port. The first fluid port is configured to connect to a fluid collection device to receive a fluid sample from the fluid collection device into the housing. The second port is configured to pass the fluid sample from the housing into a testing instrument. The zone is formed in the housing. The zone is constructed of a material that allows an analysis of the fluid sample positioned within the housing, and located adjacent to the zone.