Urine Analysis Device Dual Sample Fluorescence Detection

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Solution Overview

Problem

Current urine specimen analysis devices face challenges in precisely analyzing in-urine physical components due to cell damage or deformation during passage through the glomerulus or ureter, leading to inaccurate detection based on cell forms.

Innovation Solution

The device prepares two measurement samples: one without hemolyzing red blood cells to precisely detect non-nucleated components and another with hemolyzed red blood cells to prevent detection errors, using specific staining dyes and fluorescence signals to differentiate and classify cells and particles based on nucleic acid content and membrane stainability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If cell form-based detection is used, then the detection method is simple, but the detection precision deteriorates due to cell damage and deformation

Engineering Contradiction:
Improvedetection method simplicityVSAvoidcell detection precision
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The invention changes the detection parameter from cell form (morphology) to cell composition (nucleic acid content and membrane properties). By using staining dyes that bind to nucleic acids and cell membranes, the system detects cells based on their biochemical parameters rather than physical shape, thereby achieving accurate detection even when cells are damaged or deformed during passage through the urinary tract.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If red blood cells are not hemolyzed, then non-nucleated particle detection is accurate, but detection errors occur due to red blood cell interference

Engineering Contradiction:
Improvenon-nucleated particle detection precisionVSAvoiddetection reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention segments the detection process into two distinct measurement samples: one where red blood cells remain intact for detecting non-nucleated particles, and another where red blood cells are hemolyzed for detecting nucleated cells. This segmentation allows each sample to be optimized for specific detection purposes, eliminating interference while maintaining accuracy for different cell types.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention uses staining dyes as intermediaries to differentiate between cell types. The first staining dye targets cell membranes while the second staining dye targets nucleic acids. These intermediaries enable the system to distinguish red blood cells from other particles and to detect white blood cells and bacteria even in the presence of red blood cells, thereby resolving the detection conflict.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If a single measurement sample is used, then the analysis process is simple, but the analysis precision deteriorates due to inability to distinguish different cell types

Engineering Contradiction:
Improveanalysis process complexityVSAvoidcell type differentiation precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The invention divides the urine specimen into two separate measurement samples, each prepared with different staining conditions. The first measurement sample uses a staining dye that binds to cell membranes, while the second uses a staining dye that binds to nucleic acids. This segmentation enables the system to differentiate between nucleated and non-nucleated cells by comparing results from both samples, achieving high precision in cell type identification.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention creates a multi-functional analysis system where two measurement samples serve different detection purposes. The first sample optimized for detecting non-nucleated particles and the second sample optimized for detecting nucleated cells. Together, they provide comprehensive urine analysis capability, allowing the system to identify multiple cell types and particles within a single analytical workflow.

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

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

This configuration enables precise detection and classification of in-urine physical components, such as red blood cells, white blood cells, and bacteria, by distinguishing between nucleated and non-nucleated particles, improving analysis accuracy and reducing errors caused by cell deformation or damage.

Implementation Method 1

at least red blood cells are detected from the first measurement sample prepared using the first staining dye that stains red blood cells

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

at least white blood cells are detected from the second measurement sample prepared using the second staining dye that stains nucleic acids

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP2963418B1Urine sample analysis device and urine sample analysis method
Publication Date: 2023.04.12 SYSMEX CORP
  • EP2963418B1 patent drawingFigure 1
  • EP2963418B1 patent drawingFigure 2
  • EP2963418B1 patent drawingFigure 3

AI summary

A specimen analysis device 100 prepares a first measurement sample from a urine specimen, a diluting solution 19u having no hemolytic action, and a staining solution 18u that stains membranes, supplies the first measurement sample to a flow cell 51 and emits laser light thereon, thereby receiving fluorescence emitted from the first measurement sample, and obtains a fluorescence signal. Furthermore, the specimen analysis device 100 prepares a second measurement sample from the urine specimen, a diluting solution 19b having a hemolytic action, and a staining solution 18b that stains nuclei, supplies the second measurement sample to the flow cell 51 and emits laser light thereon, thereby receiving fluorescence emitted from the second measurement sample, and obtains a fluorescence signal. Particles not having nucleic acids, including red blood cells, are detected based on information on the fluorescence signal obtained from the first measurement sample, and cells having nucleic acids, including white blood cells, are detected based on information on the fluorescence signal obtained from the second measurement sample.