Particle Analyzer Staining Abnormality Detection via Dual Control Particles

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Solution Overview

Problem

Existing particle analyzers cannot discern abnormalities in the staining step, leading to inaccurate measurement results due to the inability to differentiate between detection and staining issues.

Innovation Solution

A method involving the use of first control particles that are stained with a fluorescent dye and second control particles that emit fluorescence but are not stained, where the ratio of their detected fluorescence values is used to determine abnormalities in the staining step, allowing for separate analysis of detection and staining performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If quality control is performed using only first standard particles and second standard particles with fixed reference ranges, then abnormality in fluorescence detector or specimen preparation mechanism can be determined, but abnormality in the staining step cannot be discerned

Engineering Contradiction:
Improveabnormality detection accuracyVSAvoidstaining step information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The invention segments the quality control process into three distinct evaluation dimensions: (1) fluorescence detector performance using second standard particles, (2) specimen preparation mechanism using first standard particles, and (3) staining step performance using the ratio between first and second standard particles. This segmentation allows independent evaluation of each component, enabling identification of staining abnormalities that were previously indistinguishable from other sources of error.

Inventive Principle:
Principle #1Segmentation

2Device complexity

If the particle analyzer uses a single quality control substance with fixed reference ranges, then the device complexity is low, but the measurement precision for identifying specific abnormality sources is insufficient

Engineering Contradiction:
Improvequality control procedureVSAvoidabnormality localization accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The invention introduces a ratio value as an intermediary parameter that mediates between the fluorescence intensity measurements of first and second standard particles. This ratio serves as a specific indicator for staining step performance, allowing the system to precisely identify staining abnormalities without requiring complex multi-step procedures. The intermediary ratio simplifies the evaluation while maintaining high precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 accurate identification of staining abnormalities, preventing inaccurate analysis and ensuring proper functioning of the particle analyzer by distinguishing between detection and staining issues, thereby improving measurement reliability.

Implementation Method 1

first control particles which are to be stained by the fluorescent dye

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

second control particles which are not to be stained by the fluorescent dye and which emit fluorescence

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP3002581B1Method for determining abnormality in particle analyzer and particle analyzer
Publication Date: 2019.01.16 SYSMEX CORP
  • EP3002581B1 patent drawingFigure 1
  • EP3002581B1 patent drawingFigure 2A~2D
  • EP3002581B1 patent drawingFigure 3

AI summary

Disclosed is a method for determining abnormality in a particle analyzer (10). The method includes: staining first control particles but not staining second control particles which emit fluorescence; irradiating with light the first control particles and the second control particles flowing in a flow cell, and detecting fluorescence from the first control particles and the second control particles; obtaining a first management value indicating a detection result of the fluorescence emitted from the first control particles and a second management value indicating a detection result of the fluorescence emitted from the second control particles; and determining abnormality in the staining step, based on a value calculated from the first management value and the second management value or a ratio between the first management value and the second management value.