Dual-Electrode Test Strip Hematocrit Correction
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Solution Overview
Problem
Point-of-care testing devices face challenges in accurately measuring analyte concentrations due to interference from varying hematocrit levels, which can lead to incorrect glucose readings, and existing methods require more blood volume and are costly, making them unsuitable for self-use and clinical standards.
Innovation Solution
A method using a test strip with dual electrode sets and a reaction reagent layer, where square wave voltammetry is applied to one electrode set to determine hematocrit values, allowing for calibration of analyte concentration measurements using a calibrated linear equation derived from hematocrit values, thereby correcting detection biases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If plasma is used as test sample to avoid hematocrit interference, then measurement accuracy is improved, but more blood volume is required and operation complexity increases
Solution Approach 1:
The patent converts the harmful effect of hematocrit variation into a useful measurement parameter. By measuring hematocrit value first and then using it to correct the analyte concentration measurement, the system transforms the interference source into a calibration reference, eliminating measurement bias without requiring plasma separation.
Solution Approach 2:
The patent introduces hematocrit value as an intermediary parameter that mediates between the raw measurement signal and the final analyte concentration result. The measurement system first obtains hematocrit value, then uses this intermediate value to calculate correction factors that are applied to the analyte concentration measurement, thereby eliminating hematocrit interference.
2Measurement precision
If plasma separation is performed to eliminate hematocrit interference, then detection bias is reduced, but detection time and operation complexity increase
Solution Approach 1:
The patent performs preliminary measurement of hematocrit value before conducting the analyte concentration measurement. This preliminary action allows the system to pre-calculate the appropriate correction factor based on the measured hematocrit value, so that when the analyte measurement is completed, the correction can be immediately applied without requiring time-consuming plasma separation.
Solution Approach 2:
The patent converts the time-consuming plasma separation process into a rapid electronic correction calculation. Instead of physically separating plasma which takes time, the system measures hematocrit electrically and uses software algorithms to correct the measurement in real-time, dramatically reducing detection time while maintaining accuracy.
3Ease of operation
If whole blood is used for direct measurement to simplify operation, then ease of use is improved, but measurement accuracy deteriorates due to hematocrit interference
Solution Approach 1:
The patent implements a feedback mechanism where the measured hematocrit value is fed back into the calculation system to adjust and correct the analyte concentration result. The system continuously monitors hematocrit level and dynamically adjusts the measurement calculation based on this feedback, ensuring accurate results across varying hematocrit conditions while maintaining simple whole-blood operation.
Solution Approach 2:
The patent introduces a mathematical correction model as an intermediary between the raw whole-blood measurement signal and the final analyte concentration result. This correction model uses hematocrit value as input to calculate appropriate adjustment factors, effectively mediating the interference effect and enabling accurate measurements from whole blood samples.
4Measurement precision
If hematocrit calibration is implemented to correct measurement bias, then measurement accuracy across different hematocrit levels is improved, but device complexity increases
Solution Approach 1:
The patent replaces complex mechanical plasma separation systems with electrical measurement and software-based correction algorithms. Instead of using centrifuges or filtration mechanisms to separate plasma, the system uses electrical signals to measure hematocrit and applies mathematical corrections, significantly reducing mechanical complexity while improving measurement accuracy across different hematocrit levels.
Solution Approach 2:
The patent changes the measurement parameter from direct analyte concentration to a two-parameter system: hematocrit value and corrected analyte concentration. By measuring hematocrit as an additional parameter and using it to transform the analyte measurement, the system achieves accurate results across varying hematocrit conditions without requiring complex hardware modifications.
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 enables precise and accurate measurement of analyte concentrations, reducing detection biases caused by hematocrit variations and conforming to FDA standards for hematocrit ranges, making it suitable for self-use devices and improving measurement accuracy across a wide hematocrit range.
Implementation Method 1
applying a first voltage to the first electrode set by voltammetry to obtain a first response value; calculating a hematocrit value according to the first response value
Implementation Method 2
applying a second voltage to the second electrode set to obtain a second response value; calculating the actual value of the analyte concentration by using the hematocrit value and the second response value
Implementation Method 3
a reaction reagent layer disposed on the second reaction area
Data Source
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AI summary
The present disclosure provides a method for detecting an analyte concentration. The method includes providing a test strip, which includes a first electrode set including a first reaction area, a second electrode set including a second reaction area, and a reaction reagent layer disposed on the second reaction area. The method includes providing a blood sample and bringing the blood sample into contact with the first electrode set and the second electrode set, applying a first voltage to the first electrode set by voltammetry to obtain a first response value, calculating a hematocrit value according to the first response value, applying a second voltage to the second electrode set to obtain a second response value, and calculating the actual value of the analyte concentration by using the hematocrit value and the second response value.