Test Sensor Reagent Cellulose Polymer Stability

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Solution Overview

Problem

Current test sensors experience instability due to incompatible components, particularly polyethylene oxide (PEO), which affects the enzyme and electron transfer mediator, leading to poor stability and prolonged assay times, especially when the total assay time is less than 35 seconds.

Innovation Solution

A test sensor reagent composition incorporating a cellulose polymer, such as hydroxyethyl cellulose (HEC), an enzyme like glucose oxidase, and an electron transfer mediator, along with rheological additives, is used to stabilize the sensor and reduce assay time by improving compatibility and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If polyethylene oxide (PEO) is used as a reagent component, then the reagent can be formulated, but test sensor stability deteriorates due to incompatibility with enzyme and electron transfer mediator

Engineering Contradiction:
Improvereagent formulationVSAvoidtest sensor stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent changes the chemical composition parameters of the reagent by replacing PEO with cellulose polymer. This substitution fundamentally alters the reagent's chemical properties, eliminating the incompatibility issue while maintaining the desired formulation capabilities and improving test sensor stability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs a disposable test sensor design where the reagent is pre-formulated with cellulose polymer. Each sensor is designed for single use, eliminating the need for long-term stability of the reagent components beyond the assay period, while ensuring optimal performance during the brief assay window.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Ease of manufacture

If test sensor reagent contains incompatible components, then formulation is achieved, but assay time increases beyond 35 seconds due to instability

Engineering Contradiction:
Improvereagent formulationVSAvoidassay time
Core Design Contradiction:
Ease of manufactureVSLoss of time

Solution Approach 1:

The patent modifies the reagent composition by substituting PEO with cellulose polymer, which changes the chemical environment to be compatible with the enzyme and electron transfer mediator. This parameter change enables the assay to complete within the target 35 seconds by eliminating instability-related delays.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If reagent components are incompatible with enzyme and electron transfer mediator, then reagent can be manufactured, but test sensor stability deteriorates over time

Engineering Contradiction:
Improvereagent manufacturingVSAvoidtest sensor shelf-life
Core Design Contradiction:
Ease of manufactureVSDuration of action of stationary object

Solution Approach 1:

The patent changes the chemical composition from PEO-based to cellulose polymer-based reagent. This fundamental parameter change creates a compatible chemical environment that maintains enzyme and electron transfer mediator activity throughout the intended shelf-life and use-life of the test sensor.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent designs the test sensor as a disposable device with a reagent formulated for optimal short-term performance. The cellulose polymer-based reagent ensures stability throughout the product's shelf-life and brief use-life, after which the sensor is discarded, eliminating the need for long-term component compatibility.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 use of cellulose polymers in the reagent composition enhances test sensor stability, reduces assay time to less than 35 seconds, and extends the shelf-life and use-life of the sensors by maintaining enzyme activity and reducing background current.

Implementation Method 1

The reagent comprises an enzyme, an electron transfer mediator, a cellulose polymer and a rheological additive... assists in stabilizing the test sensor and reducing background current

Methodology Applied
Scientific EffectEnzyme stabilization: Enzyme

Implementation Method 2

The fluid is drawn into a capillary channel that extends in the test sensor from the testing end to the reagent material by capillary action

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS8940153B2Test sensor reagent having cellulose polymers
Publication Date: 2015.01.27 ASCENSIA DIABETES CARE HLDG AG
  • US8940153B2 patent drawing
  • US8940153B2 patent drawing
  • US8940153B2 patent drawing

AI summary

A test sensor reagent for measuring the concentration of analytes in body fluids includes cellulose polymers for improving the stability of the test sensor and reducing the total assay time. The test sensor reagent also includes an enzyme, an electron transfer mediator and a rheological additive.