Low Salt Biosensor Reagent Composition for Rapid Analyte Detection

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Solution Overview

Problem

Conventional biosensors face challenges in providing accurate and precise analyte concentration measurements, especially in varying hematocrit levels, and require longer times to generate reliable output signals due to high total salt concentrations in reagent compositions.

Innovation Solution

A biosensor system with a low total salt reagent composition, including a binder, buffer salt, mediator with up to 20% inorganic non-transition metal salt, and an enzyme system, which allows for rapid signal measurement within 7 seconds and accurate correlation with analyte concentrations across a wide range of hematocrit contents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high total salt concentrations are used in reagent compositions, then the biosensor can maintain stability and specificity, but the analysis time increases and accuracy decreases

Engineering Contradiction:
Improvestability and specificityVSAvoidanalysis time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent applies parameter changes by reducing the total salt concentration in the reagent composition from conventional high levels to specifically controlled low levels (buffer salt at most 9.54 nmol/mm² and inorganic non-transition metal salt at most 20% w/w in mediator). This parameter modification enables faster analysis time (within 7 seconds) while maintaining measurement accuracy across varying hematocrit levels, directly resolving the contradiction between stability and analysis time.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If high total salt concentrations are used in reagent compositions, then the biosensor can maintain reliability, but measurement precision decreases

Engineering Contradiction:
ImprovereliabilityVSAvoidaccuracy in analyte concentration determination
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent modifies the salt concentration parameters in the reagent composition to achieve low total salt levels while maintaining reliability. Specifically, buffer salt is limited to 9.54 nmol/mm² and inorganic non-transition metal salt to 20% w/w in the mediator. This parameter change enables precise analyte concentration measurements across a wide range of hematocrit contents, eliminating the trade-off between reliability and measurement precision.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If conventional reagent compositions are used, then the biosensor can operate with standard materials, but analysis time is prolonged

Engineering Contradiction:
Improveuse of conventional materialsVSAvoidanalysis speed
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent changes the compositional parameters of the reagent system by reducing salt concentrations to achieve rapid analysis within 7 seconds. This modification improves productivity (analysis speed) while maintaining ease of manufacture through the use of standard reagent materials, simply adjusted to lower salt levels, thus resolving the contradiction between manufacturing simplicity and analysis speed.

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

The system achieves improved accuracy and precision in analyte concentration determination, reducing analysis time and correcting for errors associated with hematocrit variations, while maintaining stability and specificity.

Implementation Method 1

the analyte concentration is determined from an electrical signal generated by an oxidation/reduction or redox reaction of the analyte

Methodology Applied
Scientific EffectOxidation/reduction reaction: Redox Reactions

Implementation Method 2

An oxidoreductase, such as an enzyme or similar species, may be added to the sample to enhance the electron transfer from a first species to a second species during the redox reaction

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 3

enhance the electron transfer from a first species to a second species during the redox reaction

Methodology Applied
Scientific EffectElectron transfer: Redox Reactions

Implementation Method 4

the analyte concentration is determined from an electrical signal generated by an oxidation/reduction or redox reaction of the analyte

Methodology Applied
Scientific EffectElectrical signal detection: Conduction (electrical)

Data Source

PatentEP2373805B1Low total salt reagent compositions and systems for biosensors
Publication Date: 2015.11.04 ASCENSIA DIABETES CARE HLDG AG
  • EP2373805B1 patent drawingFigure 1A~2
  • EP2373805B1 patent drawingFigure 3
  • EP2373805B1 patent drawingFigure 4

AI summary

A biosensor system for determining the concentration of an analyte in a sample is disclosed that includes a reaction means for selectively performing a redox reaction of an analyte, and a measurement means for measuring a rate of the redox reaction of the analyte. The reaction means includes a binder, a buffer salt, a mediator including at most 20% (w/w) of an inorganic, non-transition metal salt, and an enzyme system. The measurement means includes at least two conductors. The measurement means measures an output signal value from the reaction means at a maximum kinetic performance within at most 7 seconds of introducing a sample to the reaction means, where the output signal value is responsive to the concentration of the analyte in the sample, and the measurement means determines at least one ?S value responsive to at least one error parameter. The measurement means further determines the analyte concentration in the sample from a compensation equation including at least one reference correlation and the at least one ?S value, where the compensation equation has a R2 value of at least 0.5.