Biosensor Control Solution Detection via Dual Electron Mediators

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Solution Overview

Problem

Existing biosensor systems face challenges in accurately distinguishing between control solutions and actual patient samples, leading to potential inaccuracies in measurement and patient recordkeeping, which can result in incorrect diagnoses.

Innovation Solution

The system employs a reaction reagent system with a primary and secondary electron mediator, where the secondary mediator undergoes an electrochemical redox reaction at a distinct potential, allowing for automatic differentiation between control solutions and patient samples through a two-step potential waveform applied to the electrodes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single electron mediator is used in the biosensor, then the device complexity is reduced, but the ability to distinguish between control solutions and patient samples is insufficient

Engineering Contradiction:
Improvedistinguishing accuracyVSAvoidreagent system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The single electron mediator system is segmented into two distinct electron mediators with different redox potentials. The first electron mediator (e.g., ferricyanide) operates at a lower potential for patient sample measurement, while the second electron mediator (e.g., ferrocene derivative) operates at a higher potential for control solution detection. This segmentation allows the system to reliably distinguish between control and patient samples by detecting which mediator is present.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses electron mediators as intermediary substances that facilitate the distinction between control solutions and patient samples. The first electron mediator serves as an intermediary for normal glucose measurement, while the second electron mediator acts as an intermediary marker specifically for control solutions. The meter detects the presence or absence of these intermediary mediators to determine sample type.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If control solutions and patient samples are not distinguished, then the measurement process is simplified, but the patient recordkeeping accuracy deteriorates

Engineering Contradiction:
Improverecordkeeping accuracyVSAvoiddetection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system incorporates feedback through the detection of electron mediator presence. When a control solution is detected (via the second electron mediator signal), the system provides feedback to switch to control solution testing mode. When only the first electron mediator is present, feedback indicates patient sample mode. This automated feedback mechanism ensures accurate recordkeeping without manual intervention.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The biosensor system performs self-identification of sample type through the inherent chemical properties of the control solution (presence of second electron mediator). The system automatically detects whether it is testing a control solution or patient sample without requiring user input, thereby ensuring accurate recordkeeping and preventing erroneous data recording.

Inventive Principle:
Principle #25Self-service

3Reliability

If a two-step potential waveform is applied, then the distinction between control and patient samples is improved, but the measurement time increases

Engineering Contradiction:
Improvesample differentiation accuracyVSAvoidtesting duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The measurement process uses periodic application of different potentials in a standardized sequence. The first potential step measures the first electron mediator signal, and the second potential step measures the second electron mediator signal. This periodic action pattern allows reliable sample differentiation while maintaining efficient testing throughput through automated sequential measurement.

Inventive Principle:
Principle #19Periodic action

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 effectively prevents erroneous recording of control solution results as actual patient data, ensuring accurate patient records and reducing the risk of misdiagnosis by clearly distinguishing between control and patient samples.

Implementation Method 1

the secondary mediator undergoes an electrochemical redox reaction at a distinct potential, allowing for automatic differentiation between control solutions and patient samples

Methodology Applied
Scientific EffectElectrochemical redox reaction: Redox Reactions

Data Source

PatentUS8647487B2System and methods for automatically recognizing a control solution
Publication Date: 2014.02.11 TRIVIDIA HEALTH INC
  • US8647487B2 patent drawing
  • US8647487B2 patent drawing
  • US8647487B2 patent drawing

AI summary

Methods and devices for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor are provided. The solution is introduced into an electrochemical cell having a working and counter electrode. Electric pulses are applied to the cell and resultant signals are measured. Based on a comparison of the measured signals, a meter can determine whether the sample is a control solution or an actual patient/user sample.