Electrochemical Test Strip Rapid Analysis Method

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Solution Overview

Problem

Existing electrochemical methods for analyte detection in physiological fluids, such as glucose monitoring, often require extended time periods for accurate results, and expedient methods may lack precision, necessitating a rapid and accurate measurement technique.

Innovation Solution

A method utilizing an electrochemical test strip with spaced electrodes and a reagent layer, where a first and second electric potential are applied to generate time-current transients, allowing for the calculation of analyte concentration through integrated current values, reducing computational complexity and assay time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If complete analyte depletion is waited for before measurement, then measurement accuracy is improved, but analysis time increases significantly

Engineering Contradiction:
Improveanalyte concentration measurement accuracyVSAvoidanalysis time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by performing a rapid mixing phase before the measurement phase. The analyte is pre-mixed with the reaction solution containing mediator and enzyme, allowing the reaction to proceed for a predetermined short time period (e.g., 5 seconds) before measurement. This preliminary mixing and reaction phase ensures that the system is properly prepared for measurement without requiring complete analyte depletion, thus achieving accurate results in reduced time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements partial action by measuring the analyte concentration before complete depletion occurs. Instead of waiting for 100% analyte consumption, the method measures at a predetermined time point when partial reaction has occurred. The measurement is performed on the remaining analyte or reaction products at this intermediate stage, which is sufficient to calculate the initial analyte concentration through appropriate mathematical relationships, thereby reducing total analysis time while maintaining accuracy.

Inventive Principle:
Principle #16Partial or excessive action

2Productivity

If shorter measurement time is used, then productivity is improved, but measurement precision deteriorates

Engineering Contradiction:
Improvetesting throughputVSAvoidanalyte concentration accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies periodic action through its two distinct phases: a rapid mixing phase and a measurement phase. The mixing phase occurs first for a predetermined time period, followed by the measurement phase. This periodic structure allows the system to complete the chemical reaction quickly before measurement, enabling high throughput while ensuring that the measurement is taken at the optimal moment when sufficient reaction has occurred for accurate quantification.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent utilizes parameter changes by controlling the timing and duration of the mixing phase. By adjusting the predetermined time period for mixing and reaction before measurement, the method optimizes the balance between reaction completion and measurement speed. This parameter control ensures that measurements are taken at the optimal time point, achieving both high productivity and maintained precision.

Inventive Principle:
Principle #35Parameter changes

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

Enables rapid and accurate determination of analyte concentrations, minimizing the influence of hematocrit and temperature variations, and providing results in less than 10 seconds, with improved precision and reduced test strip variation.

Implementation Method 1

an amount corresponding to the concentration of the component to be analyzed, i.e. analyte. The quantity of the oxidizable (or reducible) substance present is then estimated electrochemically

Methodology Applied
Scientific EffectElectrochemical measurement:

Implementation Method 2

The component to be analyzed is allowed to react directly with an electrode, or directly or indirectly with a mediator to form an oxidizable (or reducible) substance

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 3

The component to be analyzed is allowed to react directly with an electrode, or directly or indirectly with a mediator to form an oxidizable (or reducible) substance

Methodology Applied
Scientific EffectReduction: Reduction

Data Source

PatentEP2280276B1Method for rapid electrochemical analysis
Publication Date: 2020.05.20 LIFESCAN INC
  • EP2280276B1 patent drawingFigure 1~4
  • EP2280276B1 patent drawingFigure 5
  • EP2280276B1 patent drawingFigure 6~7

AI summary

Methods and apparatus for electrochemically determining an analyte concentration value in a physiological sample are disclosed. The methods include using a test strip in which two time-current transients are measured by a meter electrically connected to an electrochemical test strip. Integrative current values are derived from the time-current transients and used in the calculation of analyte concentration.