Electrochemical Sensor Analyte Measurement Correction
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Solution Overview
Problem
Existing analyte concentration measurement methods in medical testing face challenges due to varying hematocrit levels, temperature fluctuations, and sensor degradation, leading to inaccurate results and increased sample handling time.
Innovation Solution
A method involving an electrochemical sensor system that corrects analyte concentration values by measuring current outputs, accounting for fill time and capacitance, and applying temperature corrections to achieve accurate and reliable measurements across different hematocrit levels and storage conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If plasma separation or separate haematocrit measurement is performed to account for varying haematocrit levels, then measurement accuracy is improved, but sample handling time and device complexity increase
Solution Approach 1:
The invention extracts the plasma from the whole blood sample by allowing it to separate and flow into a dedicated plasma analysis chamber, leaving the cellular components (including varying haematocrit levels) in the blood chamber. This separation enables the plasma to be analyzed independently without the interference of cellular elements, achieving accurate analyte concentration measurements without requiring separate centrifugation or manual plasma separation procedures.
Solution Approach 2:
The test strip is divided into distinct functional chambers: a blood chamber for receiving and holding the whole blood sample, and a plasma chamber for receiving and analyzing the separated plasma. This segmentation allows the system to handle different sample types (whole blood vs. plasma) in different zones, enabling accurate analyte measurement in plasma while automatically managing the haematocrit variation issue through physical separation.
2Measurement precision
If plasma separation is performed to account for varying haematocrit levels, then measurement accuracy is improved, but device complexity increases
Solution Approach 1:
The invention extracts the plasma from the whole blood sample by allowing it to separate and flow into a dedicated plasma analysis chamber, leaving the cellular components (including varying haematocrit levels) in the blood chamber. This separation enables the plasma to be analyzed independently without the interference of cellular elements, achieving accurate analyte concentration measurements without requiring separate centrifugation or manual plasma separation procedures.
Solution Approach 2:
The test strip design enables automatic plasma separation and transfer through capillary action and gravity, without requiring external centrifugation equipment or manual intervention. The plasma naturally separates from the cellular components and flows into the plasma chamber, where it is automatically analyzed. This self-service mechanism eliminates the need for complex external sample preparation devices and procedures.
3Ease of manufacture
If sensors are stored for long periods or in non-optimal conditions, then manufacturing cost is reduced, but measurement accuracy deteriorates
Solution Approach 1:
The invention applies a haematocrit correction factor to the measured analyte concentration in plasma before final result calculation. This preliminary correction accounts for the effects of varying haematocrit levels that may have developed during storage or due to different storage conditions, ensuring that the final measurement remains accurate regardless of how long or under what conditions the sensor was stored before use.
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
The system ensures accurate analyte concentration measurements with an accuracy standard of at least ±10% for glucose concentrations, with 95% of results within 10% of a reference value, reducing errors and sample handling time.
Implementation Method 1
an electrochemical cell made up of at least two electrodes, i.e., a working electrode and a counter electrode, where the electrodes have an impedance that renders them suitable for amperometric or coulometric measurement
Implementation Method 2
measuring a sample fill time with the capacitor
Data Source
AI summary
Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, a sample including an analyte is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and a first analyte concentration is determined. A second analyte concentration value is calculated from the first analyte concentration value and corrected for temperature effects, fill time and capacitance to provide for a final analyte concentration value.