Troponin Stabilization Using Anionic Surfactant Matrix

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Solution Overview

Problem

The instability of troponin proteins poses challenges in their use as calibration and control standards in immunoassays, particularly due to rapid loss of immunoactivity and limited shelf-life, requiring specialized handling and storage conditions.

Innovation Solution

A stabilized composition of troponin protein in an aqueous matrix containing sodium polyoxyethylene (1) lauryl sulfate, which provides thermal stability and maintains immunoactivity for extended periods at various temperatures, allowing for storage without special handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If troponin protein is stored in conventional conditions (freezing, lyophilization, strong reducing agents), then stability is improved, but device complexity and ease of operation deteriorate due to specialized equipment and handling procedures

Engineering Contradiction:
Improvetroponin protein stabilityVSAvoidspecialized equipment and handling procedures
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent changes the chemical parameters of the storage medium by using mild reducing agents (beta-mercaptoethanol at pH 8.0) instead of strong reducing agents (guanidine), and by adjusting pH conditions. This allows troponin to remain stable without requiring freezing or lyophilization, thereby eliminating specialized equipment and complex handling procedures while maintaining protein stability.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If troponin protein is frozen or lyophilized for stabilization, then stability is improved, but loss of time increases due to thawing or reconstitution requirements

Engineering Contradiction:
Improvetroponin protein stabilityVSAvoidthawing or reconstitution time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The patent changes the storage conditions by using a mild reducing agent system with beta-mercaptoethanol at controlled pH, which prevents protein aggregation and maintains stability at room temperature. This eliminates the need for freezing and subsequent thawing, or lyophilization and reconstitution, thereby completely eliminating the time loss associated with these processes.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If troponin protein is stored at room temperature without stabilization, then ease of operation is improved, but stability deteriorates due to rapid loss of immunoactivity

Engineering Contradiction:
Improvestorage convenienceVSAvoidimmunoactivity retention
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The patent introduces beta-mercaptoethanol as an intermediary substance that mediates between the troponin protein and the aqueous environment. This mild reducing agent protects the protein from oxidation and aggregation at room temperature, maintaining immunoactivity without requiring special storage conditions, thus achieving both ease of operation and stability.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Duration of action of stationary object

If conventional stabilization methods are used, then shelf-life is extended, but manufacturing precision increases due to requirements for specialized handling procedures

Engineering Contradiction:
Improveshelf-lifeVSAvoidhandling procedure precision
Core Design Contradiction:
Duration of action of stationary objectVSManufacturing precision

Solution Approach 1:

The patent changes the chemical parameters of the storage medium to use mild reducing agents and controlled pH conditions, which maintain troponin stability without requiring specialized handling procedures. This simplifies manufacturing while extending shelf-life, as the protein remains stable under常规 handling conditions without needing precise control of freezing, thawing, or reconstitution parameters.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP1877432B1Stabilization of cardiac troponin
Publication Date: 2010.04.07 ABBOTT LAB INC
  • EP1877432B1 patent drawingFigure 1
  • EP1877432B1 patent drawingFigure 2
  • EP1877432B1 patent drawingFigure 3

AI summary

The present invention relates to a troponin protein or complex of two troponin proteins stabilized in a matrix containing at least one anionic surfactant. The stabilized troponin or complex of troponin proteins is used as a control or calibration standard in assays for the determination of blood levels of troponin in patient samples that are expect to exhibit elevated levels of cardiac proteins. The troponin protein or complex of troponin proteins remains stabilized at room temperatures for at least six (6) months.