Chitosan-Stabilized Hematology Control Suspension for Digital Imaging

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Solution Overview

Problem

Conventional hematology controls are not suitable for digital imaging analyzers, and there is a need for compositions that provide long-term stability and reproducible results for simulated blood cells, especially for leukocyte differentials, to ensure consistent quality control in hematology analysis.

Innovation Solution

A synthetic control composition is developed, comprising simulated blood cells stabilized with chitin or chitosan derivatives, which are suspended in a buffered aqueous solution to maintain detectable characteristics for extended periods, allowing analysis by digital imaging hematology analyzers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional hematology controls are used, then they are compatible with traditional flow-based analyzers, but they are not suitable for digital imaging analyzers and lack long-term stability

Engineering Contradiction:
Improvecompatibility with digital imaging analyzersVSAvoidlong-term stability of simulated blood cells
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent changes the chemical parameters of the suspension medium by replacing lipoprotein-based formulations with buffered aqueous solutions containing specific stabilizing agents (bovine serum albumin, chitosan oligosaccharide, polyethylene glycol). This parameter change enables both compatibility with digital imaging analyzers and long-term stability of simulated blood cells at controlled temperatures.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite suspension medium combining multiple stabilizing agents (bovine serum albumin, chitosan oligosaccharide, polyethylene glycol) in a buffered aqueous solution. This composite formulation provides synergistic effects that maintain cell morphology and prevent aggregation, achieving both analyzer compatibility and long-term reliability.

Inventive Principle:
Principle #40Composite materials

2Duration of action of stationary object

If simulated blood cells are stored for extended periods, then long-term stability is achieved, but detectable characteristics may deteriorate

Engineering Contradiction:
Improvestorage stability of control compositionVSAvoiddetectable characteristics of blood cells
Core Design Contradiction:
Duration of action of stationary objectVSMeasurement precision

Solution Approach 1:

The patent applies preliminary stabilization actions by incorporating stabilizing agents (bovine serum albumin, chitosan oligosaccharide) into the suspension medium before storage. These agents pre-protect the simulated blood cells from degradation, aggregation, and morphological changes during extended storage periods, maintaining measurement precision throughout the storage duration.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The buffered aqueous suspension medium creates a chemically inert environment that prevents unwanted reactions and degradation of simulated blood cells during storage. The buffer system maintains stable pH and ionic conditions, effectively isolating the cells from environmental factors that could compromise their detectable characteristics.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

3Reliability

If lipoprotein is used in suspension medium, then cell preservation is improved, but compatibility with digital imaging analyzers is reduced

Engineering Contradiction:
Improvepreservation of processed cellsVSAvoidusefulness with digital imaging hematology analyzers
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent fundamentally changes the suspension medium composition by eliminating lipoprotein and replacing it with a buffered aqueous solution containing stabilizing agents. This parameter change resolves the incompatibility with digital imaging analyzers while maintaining cell preservation through alternative stabilization mechanisms.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces buffered aqueous solutions with stabilizing agents (bovine serum albumin, chitosan oligosaccharide) as intermediary substances that perform the cell preservation function previously provided by lipoprotein. These intermediaries maintain cell integrity and prevent aggregation without interfering with digital imaging analyzer detection.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of operation

If simulated blood cells are dispensed onto substrate for digital imaging analysis, then analysis by digital imaging systems is enabled, but cell stability on substrate is challenging

Engineering Contradiction:
Improvedispensing and analysis capabilityVSAvoidstability of simulated cells on substrate
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent modifies the suspension medium parameters to include dispersing agents (polyethylene glycol) and stabilizing agents that maintain cell integrity during dispensing and on substrate. These parameter changes enable easy dispensing onto substrates while maintaining cell stability and detectable characteristics for digital imaging analysis.

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 composition ensures prolonged stability of simulated blood cells, retaining relevant detectable characteristics for at least 105 days, enabling reliable quality control and accurate analysis of leukocyte differentials in digital imaging systems.

Implementation Method 1

A synthetic control composition is developed, comprising simulated blood cells stabilized with chitin or chitosan derivatives, which are suspended in a buffered aqueous solution to maintain detectable characteristics for extended periods

Methodology Applied
Scientific EffectStabilization by chitin/chitosan:

Implementation Method 2

suspended in a buffered aqueous solution to maintain detectable characteristics for extended periods

Methodology Applied
Scientific EffectBuffering:

Data Source

PatentEP3491381B1Suspension composition for hematology analysis control
Publication Date: 2025.09.24 STRECK LLC
  • EP3491381B1 patent drawingFigure 1~2
  • EP3491381B1 patent drawingFigure 3a~3b
  • EP3491381B1 patent drawingFigure 4a~4b

AI summary

A suspension composition for a hematology analysis control particularly useful for preserving relevant detectable characteristics of blood cells for a prolong stability period. The suspension may include at least one polysaccharide, which may include or derive from chitosan and/or chitin, as a stabilizing agent.