Blood Testing Device With Plasma Separation for Hemolysis Detection
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Solution Overview
Problem
Existing point-of-care testing methods fail to rapidly and accurately determine hemolysis in blood samples, leading to interference with analytical test results and potential misdiagnosis due to false positive readings, particularly in potassium level tests.
Innovation Solution
A blood testing device with a separator and reagent system that uses colorimetric assessment to indicate hemolysis by separating blood cells from plasma and reacting with hemoglobin in the plasma to change color, allowing for visual or reader-based comparison against a color palette.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If hemolysis detection is not performed, then testing process is simple and fast, but test result accuracy deteriorates due to interference from free hemoglobin
Solution Approach 1:
The testing process is divided into distinct stages: sample application, hemolysis detection using a dedicated detection zone with reagent, and subsequent analytical testing. The detection zone is spatially separated from the test zones, allowing hemolysis assessment to be performed independently without interfering with the main analytical measurements.
Solution Approach 2:
Hemolysis detection is performed as a preliminary step before the main analytical testing. The detection zone is positioned to be reached first by capillary action, allowing the system to assess hemolysis status and determine whether to proceed with or without correction factors for the subsequent potassium and other analyte measurements.
2Reliability
If hemolysis detection is implemented, then false positive results are prevented, but testing time increases due to additional detection steps
Solution Approach 1:
The hemolysis detection system is self-contained within the test strip, utilizing capillary action to automatically transport sample through the detection zone without requiring external pumping or manual intervention. The reagent in the detection zone automatically reacts with free hemoglobin to produce a visible color change, eliminating the need for separate detection equipment or additional time-consuming processing steps.
3Ease of operation
If colorimetric reagent is used for hemolysis detection, then visual assessment is simple, but reagent stability and storage requirements become more complex
Solution Approach 1:
The detection zone contains a reagent that undergoes a distinct color change when it reacts with free hemoglobin released from lysed red blood cells. This colorimetric response provides a clear visual indicator of hemolysis presence and severity, allowing users to quickly assess sample quality without requiring sophisticated instrumentation or complex interpretation protocols.
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 detection of hemolysis, preventing false positive results and ensuring the integrity of test results, particularly for potassium levels, by providing a clear indication of hemoglobin presence or absence.
Implementation Method 1
a separator configured to separate blood cells from plasma and direct the plasma to an inspection zone
Implementation Method 2
a reagent positioned within the inspection zone and adjacent to the window so that the reagent is visible through the window. The reagent is configured to change colors in the presence of hemoglobin within the plasma
Data Source
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AI summary
A blood testing assembly and method are described. In the method, a blood testing device having a plasma separation membrane and a reagent is connected to a syringe containing blood having blood cells and plasma. A blood sample of the blood is passed from the syringe through a plasma separation membrane within the blood testing device to separate the plasma from the blood cells. A reagent is saturated with the plasma, and then the reagent is colorimetrically analyzed to determine a degree of hemolysis within the blood sample.