Glucose Biosensor Hematocrit Bias Correction via Plasma Extraction
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Solution Overview
Problem
Current glucose-monitoring products face significant glucose bias due to varying hematocrit levels in blood samples, leading to inaccurate glucose readings, which can mislead patients and result in inappropriate insulin administration or missed treatments.
Innovation Solution
The method involves measuring the resistance of blood samples using a biosensor reagent to calculate the hematocrit level, adjusting the glucose value accordingly, and using these adjustments to correct for bias, allowing for more accurate glucose readings without the need for clinical or laboratory settings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If biosensor reagents are used to measure glucose in whole blood samples, then glucose monitoring can be performed at home without clinical settings, but RBC interference causes glucose bias that varies with hematocrit levels
Solution Approach 1:
The patent uses an intermediary substance (defibrinated plasma or plasma substitute) to separate the glucose measurement from the interfering RBCs. By measuring glucose in the plasma fraction rather than whole blood, the RBC interference is eliminated while still allowing home testing convenience. The plasma acts as a mediator that contains the glucose without the interfering cellular components.
Solution Approach 2:
The patent segments the whole blood sample into plasma and cellular components, then performs glucose measurement only on the plasma fraction. This segmentation separates the analyte (glucose in plasma) from the interferent (RBCs), allowing accurate measurement while maintaining the simplicity of home testing. The blood sample is divided into measurable and non-measurable portions.
2Measurement precision
If hematocrit adjustment methods are implemented to correct glucose bias, then glucose reading accuracy improves, but the device complexity increases
Solution Approach 1:
The patent changes the measurement parameter from whole blood glucose to plasma glucose, which inherently eliminates hematocrit dependence. By measuring in the plasma fraction where hematocrit does not apply, the need for complex adjustment calculations and algorithms is avoided. This parameter change simplifies the device while improving accuracy across different hematocrit levels.
Solution Approach 2:
The patent extracts the plasma fraction from the whole blood sample and performs glucose measurement only on this extracted portion. By taking out the plasma containing glucose and leaving behind the RBCs that cause interference, the measurement becomes independent of hematocrit variations without requiring complex adjustment mechanisms in the device.
3Productivity
If RBC interference is present in glucose measurements, then the measurement process remains simple and quick, but glucose bias occurs that leads to inappropriate insulin administration
Solution Approach 1:
The patent introduces plasma as an intermediary medium that allows rapid glucose measurement without RBC interference. The plasma fraction can be measured quickly using standard glucose meters, maintaining testing speed while eliminating the harmful glucose bias caused by RBCs. The intermediary plasma layer protects against interference while enabling fast measurement.
Solution Approach 2:
The patent extracts the plasma fraction from whole blood for glucose measurement. This extraction removes the RBCs that cause harmful interference and glucose bias, while the plasma containing glucose can be measured rapidly. The separation allows quick testing without the detrimental effects of cellular interference, maintaining productivity while eliminating harm.
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 provides more accurate glucose readings by reducing or eliminating the glucose bias caused by hematocrit levels, enabling patients to receive a precise assessment of their glycemic state without the need for external testing facilities.
Implementation Method 1
measuring the resistance of the blood sample (Rcell) using a biosensor reagent
Implementation Method 2
measuring the resistance of plasma (Rplasma) using the biosensor reagent
Data Source
AI summary
Methods and devices for performing in situ hematocrit adjustments during glucose testing using glucose-monitoring products and using those adjusted values to estimate the hematocrit value of blood samples to reduce or eliminate the assay bias caused by the different hematocrit levels of blood samples. One method involves measuring the glucose value, Glum, of the blood sample; measuring the resistance of the blood sample (Rcell) using a biosensor reagent; measuring the resistance of plasma (Rplasma) using the biosensor reagent; determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationshipRRBC=Rcell−Rplasma;calculating the percent hematocrit, % Hctc, of the blood sample; determining whether to adjust the glucose value, Glum, to an adjusted glucose value, Gluadj; and using the percent hematocrit, % Hctc, and either the glucose value, Glum, or the adjusted glucose value, Gluadj, to adjust for any bias of the biosensor reagent.