Immature Leukocyte Analysis Reagent Kit

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Solution Overview

Problem

Conventional reagents for analyzing blood cells struggle to accurately classify and count myeloblasts due to signal overlap with erythrocyte debris in patients with specific diseases, leading to false diagnoses and treatments.

Innovation Solution

A reagent comprising a surfactant that damages erythrocyte and mature leukocyte membranes, a solubilizing agent that shrinks damaged cells, and a nucleic acid dye selected from specific formulas, allowing clear discrimination between myeloblasts and erythrocyte debris in flow cytometry analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional reagent is used for blood cell analysis, then general leukocyte classification is possible, but myeloblast detection accuracy deteriorates due to signal overlap with erythrocyte debris

Engineering Contradiction:
Improvemyeloblast detection accuracyVSAvoidfalse diagnosis risk
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent changes the chemical composition parameters of the reagent by incorporating specific dyes (methylene blue, brilliant cresyl blue, or acridine orange) and controlling pH and ionic strength to optimize the differential staining of myeloblasts versus erythrocyte debris, enabling accurate detection despite signal overlap in conventional scattergrams

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes color changes through specific nucleic acid-staining dyes that bind differentially to myeloblasts versus erythrocyte debris, producing distinct fluorescence or color signals that allow clear discrimination between the two cell types in flow cytometry analysis

Inventive Principle:
Principle #32Color changes

2Manufacturing precision

If surfactant and solubilizing agent are added to the reagent, then erythrocyte lysis and cell shrinkage are improved, but reagent complexity increases

Engineering Contradiction:
Improveerythrocyte lysis completenessVSAvoidreagent composition complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent merges multiple reagent components (surfactant, solubilizing agent, and nucleic acid dye) into a single integrated reagent formulation that performs multiple functions simultaneously - lysing erythrocytes, shrinking damaged cells, and staining nucleic acids - thereby achieving complete erythrocyte lysis without proportionally increasing operational complexity

Inventive Principle:
Principle #5Merging (Combining)

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

Enables precise classification and counting of immature and mature leukocytes, even in samples from patients with diseases like multiple myeloma, by effectively distinguishing myeloblasts from erythrocyte debris, thereby reducing false detection and improving diagnostic accuracy.

Implementation Method 1

a surfactant which can damage cell membranes of erythrocytes and mature leukocytes

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Implementation Method 2

a solubilizing agent which can shrink the damaged blood cells

Methodology Applied
Scientific EffectOsmotic pressure: Osmotic Pressure

Implementation Method 3

at least one dye for staining nucleic acid selected from the dyes of the above formulae (I) and (II)

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS9222934B2Reagent and reagent kit for analysis of immature leukocyte
Publication Date: 2015.12.29 SYSMEX CORP
  • US9222934B2 patent drawing
  • US9222934B2 patent drawing
  • US9222934B2 patent drawing

AI summary

The present invention provides a reagent for analysis of immature leukocytes comprising:a surfactant which can damage cell membranes of erythrocytes and mature leukocytes,a solubilizing agent which can shrink the damaged blood cells andat least one dye for staining nucleic acid selected from the dyes of the formulae (I) and (II), wherein X− is an anion.