Mono-reagent Blood Analysis for Device Complexity Reduction

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Solution Overview

Problem

Existing automatic blood analyzers require multiple reagents and dilution steps for complete blood sample analysis, leading to increased complexity, costs, and maintenance requirements without reducing analysis time.

Innovation Solution

A method using a single dilution and analysis tank with a mono-reagent solution containing compounds for erythrocyte lysis, haemoglobin stabilization, and leucocyte protection, allowing simultaneous measurement of haemoglobin and leucocyte counting and differentiation, reducing the need for separate analysis circuits and reagents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple reagents and dilution steps are used for complete blood sample analysis, then the completeness of analysis is improved, but the device complexity and costs increase

Engineering Contradiction:
Improvecompleteness of analysisVSAvoidnumber of reagents and analysis circuits
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple reagents (erythrocyte lysis agent, haemoglobin stabilization compound, leucocyte protection compound) into a single mono-reagent solution that can be added once to the blood sample. This single reagent mixture enables simultaneous performance of all required analyses (haemoglobin measurement, leucocyte counting, and differentiation) without requiring separate reagent additions for each measurement type, thereby reducing device complexity while maintaining analysis completeness

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The mono-reagent solution is designed to serve multiple functions simultaneously: it lyzes erythrocytes for haemoglobin release, stabilizes the released haemoglobin in a measurable form, and protects leucocytes during the analysis process. This multi-functional reagent enables a single analysis circuit to perform diverse measurements (spectrophotometric haemoglobin assay, resistive leucocyte counting, and optical differentiation) that would traditionally require separate dedicated circuits for each function

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If multiple reagents and dilution steps are used for complete blood sample analysis, then the completeness of analysis is improved, but the production and maintenance costs increase

Engineering Contradiction:
Improvecompleteness of analysisVSAvoidproduction and maintenance costs
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

By merging multiple reagent components into a single mono-reagent formulation, the patent reduces the number of separate reagent bottles, storage containers, and dispensing mechanisms required in the analyzer. This consolidation simplifies the manufacturing of the reagent system and reduces maintenance requirements for replacing multiple reagents, directly lowering production and maintenance costs while ensuring complete blood sample analysis

Inventive Principle:
Principle #5Merging (Combining)

3Device complexity

If a single dilution and mono-reagent approach is used, then the device complexity is reduced, but the analysis time may be affected

Engineering Contradiction:
Improvenumber of analysis circuitsVSAvoidanalysis time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

The patent enables continuous analysis by performing all measurements (haemoglobin spectrophotometry, leucocyte resistive counting, and optical differentiation) sequentially within a single analysis circuit without requiring time-consuming transfers between multiple circuits. The mono-reagent is added once, and all assays proceed in continuous sequence using the same diluted sample, eliminating idle time between measurements and maintaining high analysis throughput

Inventive Principle:
Principle #20Continuity of useful action

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

Simplifies the analysis equipment, reduces production and maintenance costs, and maintains the completeness of blood sample analysis while potentially shortening analysis time through a single dilution and mono-reagent approach.

Implementation Method 1

assay of the haemoglobin is carried out after lysis of the erythrocytes, i.e. the destruction of the membrane of the cells of erythrocytes

Methodology Applied
Scientific EffectLysis:

Implementation Method 2

the stabilisation of the haemoglobin in a complexed form (oxyhemoglobin or cyanmethemoglobin) in order to measure the absorbance of a single compound at the appropriate wave length

Methodology Applied
Scientific EffectComplex formation:

Implementation Method 3

measurement by spectrophotometry of the haemoglobin released in the medium

Methodology Applied
Scientific EffectAbsorbance measurement: Absorption (EM radiation)

Implementation Method 4

total leucocyte count is carried out on the blood sample by resistivity with specific lysis of the erythrocytes and protection of the leukocytes

Methodology Applied
Scientific EffectResistivity: Electrical Resistance

Implementation Method 5

by measuring different parameters (in particular diffraction, fluorescence, absorbance), on a flow of leucocytes

Methodology Applied
Scientific EffectDiffraction: Diffraction

Implementation Method 6

by measuring different parameters (in particular diffraction, fluorescence, absorbance), on a flow of leucocytes

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS7981681B2Method for the analysis of a blood sample, and apparatus and reagent for its implementation
Publication Date: 2011.07.19 C2 DIAGNOSTICS
  • US7981681B2 patent drawing
  • US7981681B2 patent drawing
  • US7981681B2 patent drawing

AI summary

Method for the automatic analysis of a blood sample in which: an analysis solution containing the blood sample, a diluent, and at least one compound to lyze the erythrocytes; at least one compound to stabilize the haemoglobin in the form of a chromogenic complex, is formed in a single dilution and analysis tank, the haemoglobin level is measured in this analysis solution by spectrophotometry in the tank after the lysis of the erythrocytes; and an appropriate quantity of this analysis solution is taken from the tank on which a leucocytic differentiation is carried out by an optical elements characterized in that the analysis solution also contains at least one compound to protect the leucocytes, allowing the distinguishing of at least four main leucocyte sub-populations. A haematological analysis apparatus for the implementation of such a method is disclosed.