CRP Analysis Kit with Selective Hemolysis and Reagent Stabilization

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Solution Overview

Problem

Existing CRP quantitative analysis technologies require separate determination of hematocrit and involve complex processes due to the absence of hemolysis, necessitating additional modifications to prevent red blood cell hemolysis, and lack sufficient investigation into stabilizers for reagent storage stability.

Innovation Solution

A kit and method utilizing a hemolytic reagent that does not affect CRP quantification, combined with a stabilizer like Trehalose and Sucrose, to enhance storage stability and simplify the analysis process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If hemolysis is prevented to maintain red blood cell integrity, then red blood cells remain stable, but separate determination of hematocrit is required and the analysis process becomes complex

Engineering Contradiction:
Improvered blood cell stabilityVSAvoidanalysis process complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent extracts the hemolytic function from the main analysis process by using a specific hemolytic reagent that selectively lyses red blood cells while leaving CRP intact. This allows the hemolysis step to be performed independently and automatically, eliminating the need for separate hematocrit determination and simplifying the overall analysis process.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a hemolytic reagent as an intermediary substance that mediates between the blood sample and the CRP analysis. This reagent selectively breaks down red blood cells without affecting CRP, enabling automatic hemolysis and eliminating the need for manual hematocrit measurement.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Device complexity

If hemolytic reagents are used to simplify the analysis process, then hematocrit determination is no longer needed, but the hemolytic reagent may affect CRP quantification accuracy

Engineering Contradiction:
Improveanalysis process complexityVSAvoidCRP quantification accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent applies local quality by selecting a hemolytic reagent with specific chemical properties (sodium deoxycholate at 0.03-0.2%) that exhibits selective action - it lyses red blood cells while having no significant effect on CRP molecules. This localized specificity ensures that hemolysis occurs only where needed without compromising CRP quantification accuracy.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent optimizes the concentration parameters of the hemolytic reagent (sodium deoxycholate at 0.03-0.2%) to achieve complete hemolysis while maintaining CRP stability. By carefully controlling the reagent concentration, the patent ensures effective red blood cell lysis without introducing interference into the CRP measurement.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If stabilizers are added to enhance reagent storage stability, then reagent stability improves, but the reagent composition becomes more complex

Engineering Contradiction:
Improvereagent storage stabilityVSAvoidreagent composition complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent employs stabilizers (trehalose and/or sucrose) that provide effective storage stability for the reagents at reasonable costs. These stabilizers protect the immunoreagent and hemolytic reagent during storage without requiring complex formulation systems, balancing stability enhancement with compositional simplicity.

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 solution enables precise CRP quantification over a wide range of concentrations with improved reagent stability and simplified usability by using Sodium Deoxycholate as the hemolytic reagent and stabilizers like Trehalose and Sucrose.

Implementation Method 1

a first composition including a hemolytic reagent for hemolyzing at least a portion of blood cells in a blood sample

Methodology Applied
Scientific EffectHemolysis:

Implementation Method 2

a second composition including an anti-CRP antibody for antigen-antibody reaction of CRP contained in the hemolyzed sample

Methodology Applied
Scientific EffectAntigen-antibody reaction:

Data Source

PatentEP4607195A1Kit for quantitative analysis of c-reactive protein, method for quantitative analysis of c-reactive protein, and apparatus for performing the same
Publication Date: 2025.08.27 I SENS INC
  • EP4607195A1 patent drawingFigure 1
  • EP4607195A1 patent drawingFigure 2
  • EP4607195A1 patent drawingFigure 3

AI summary

The kit for quantitative analysis of C-Reactive Protein (CRP) according to an embodiment of the present application may comprises: a first composition including a hemolytic reagent for hemolyzing at least a portion of blood cells in a blood sample; and a second composition including an anti-CRP antibody for antigen-antibody reaction of CRP contained in the hemolyzed sample.