Hematocrit-Corrected Lipid Analyte Test Strip
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Solution Overview
Problem
Current point-of-care lipid analyte testing systems face inaccuracies due to hematocrit interference, as red blood cells are difficult to completely separate from the sample, affecting the accuracy of measurements like LDL and HDL cholesterol levels.
Innovation Solution
A system and method that includes a test strip with dual sample windows for measuring lipid analytes and hematocrit levels, using circuitry and a microprocessor to correct lipid analyte levels based on hematocrit values, employing an algorithm that applies trigonometric principles, such as the Law of Sines, to adjust for hematocrit bias.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a red blood cell separation layer is used to remove red blood cells from the sample, then the colorimetric test accuracy is improved, but it is difficult to remove 100% of red blood cells, leaving residual interference
Solution Approach 1:
The system measures hematocrit level (the feedback parameter) and uses it to dynamically adjust the lipid analyte measurement results through mathematical correction algorithms. This closed-loop feedback approach compensates for the incomplete red blood cell removal by quantifying and correcting the residual interference.
Solution Approach 2:
The invention changes the measurement parameters by introducing hematocrit level as an additional measured parameter and using it to adjust the interpretation of the colorimetric test results. By transforming the raw optical measurement into a corrected value based on hematocrit-dependent correction factors, the system accounts for residual red blood cell interference.
2Measurement precision
If pre-calculated correction factors are used to compensate for red blood cell effects, then some accuracy improvement is achieved, but residual effects from red blood cells still affect the test
Solution Approach 1:
Instead of using fixed pre-calculated correction factors, the system implements dynamic feedback by measuring the actual hematocrit level in each sample and adjusting the correction accordingly. This allows the system to account for individual variations in red blood cell concentration and morphology, reducing residual effects that would persist with fixed correction factors.
Solution Approach 2:
The correction approach transitions from static pre-calculated factors to dynamic, sample-specific correction based on real-time hematocrit measurement. The system adapts the correction magnitude and method based on the measured hematocrit level, making the correction process responsive to actual sample conditions rather than relying on population averages.
3Measurement precision
If hematocrit level is measured and used for correction, then the accuracy of lipid analyte measurements is improved, but the device complexity and measurement time increase
Solution Approach 1:
The test strip and meter system are designed to perform multiple functions: measuring both hematocrit level and lipid analyte concentrations using the same physical platform. The dual sample window configuration and integrated circuitry enable the system to execute two measurement protocols simultaneously or sequentially without requiring separate devices, thereby reducing overall system complexity despite the added measurement capability.
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
This approach significantly improves the accuracy of lipid analyte measurements by accounting for individual hematocrit levels, reducing bias and providing more reliable patient health assessments.
Implementation Method 1
The separation of the red blood cells typically is performed using a red blood cell separation layer in the strip, which layer may, for example, be made of a glass fiber matrix.
Implementation Method 2
after isolating the analytes to be measured and reacting the analytes to produce a color change, the reflectance or some other optical measurement is taken. The optical measurement is proportional to the amount of analyte in the sample.
Implementation Method 3
The second sample window is an electrochemical sample window... configured to enable the measurement of hematocrit level
Data Source
AI summary
A system for determining a level of a lipid analyte corrected for hematocrit includes a test strip configured to receive a sample and a meter configured to receive the test strip. The system further includes circuitry and a microprocessor, the circuitry and microprocessor configured to read the test strip and the sample and determine a level of a lipid analyte and correct the level of the lipid analyte based on a hematocrit level of the sample.