Urine Staining Composition for Automated Sediment Analysis

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Solution Overview

Problem

Current urine analysis techniques face challenges in efficiently staining and differentiating particles in urine samples, particularly in automated systems, due to lengthy multi-step processes and damage to small-sized sediments like erythrocytes, bacteria, and crystals, which limits accuracy and throughput.

Innovation Solution

A particle contrast agent composition comprising Crystal Violet, a permeabilizing agent such as 5PD Lytic, and optional antimicrobial agents like Proclin 300, is used to create a rapid one-step staining process, where the sample mixture is incubated at elevated temperatures for a short duration, achieving effective staining and visualization of particles in automated systems.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If traditional multi-step staining processes are used, then staining completeness may be improved, but processing time increases and small-sized sediments are damaged

Engineering Contradiction:

Improvestaining completenessVSAvoidprocessing time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The patent combines multiple staining steps into a single-step process by formulating a contrast agent composition that contains multiple staining components (crystal violet, safranin O, and other dyes) that work simultaneously to differentiate various urine sediment particles, eliminating the need for sequential staining steps and reducing processing time while maintaining staining effectiveness

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent performs preliminary protection of small-sized sediments by including protective agents (such as bovine serum albumin and gelatin) in the contrast agent composition before staining occurs, which prevents damage to erythrocytes, bacteria, and crystals during the staining process while allowing complete staining of all particle types

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If traditional staining processes are used, then particle differentiation may be improved, but small-sized sediments like erythrocytes and bacteria are damaged

Engineering Contradiction:

Improveparticle differentiationVSAvoidsediment damage

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent applies different staining components with specific affinities to different particle types within the same sample, allowing selective differentiation of various urine sediments (white blood cells, red blood cells, bacteria, crystals, etc.) while maintaining their structural integrity through the protective agents present in the composition

Inventive Principle:

Principle #3Local quality

3Measurement precision

If manual urine sediment analysis is performed, then diagnostic accuracy may be improved, but productivity decreases

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidanalysis throughput

Core Design Contradiction:

Measurement precisionVSProductivity

Solution Approach 1:

The patent replaces manual microscopic examination with an automated digital imaging and analysis system that uses the contrast agent composition to enhance particle visibility, allowing computer-based detection and classification of urine sediments, thereby maintaining diagnostic accuracy while significantly increasing analysis throughput and productivity

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 approach enables rapid, accurate, and efficient staining of urine samples, preserving cellular integrity and enhancing visualization of particles like erythrocytes, leukocytes, and bacteria, thereby improving the accuracy and speed of automated urine analysis.

Implementation Method 1

The particle contrast agent composition can include Crystal Violet present in amounts sufficient to result in concentrations between 50 μM and 500 μM under staining conditions

Methodology Applied

Scientific EffectAdsorption: Adsorption

Implementation Method 2

The particle contrast agent composition can further include a permeabilizing agent selected from the group consisting of 5 PD Lytic and saponin

Methodology Applied

Scientific EffectPermeabilization: Permeation

Implementation Method 3

the sample mixture is incubated at elevated temperatures for a short duration, achieving effective staining and visualization of particles

Methodology Applied

Scientific EffectThermal heating: Heating

Data Source

PatentUS9939356B2Method and composition for staining and processing a urine sample

Publication Date: 2018.04.10 IRIS INTERNATIONAL INC

AI summary

The present disclosure relates to a staining methodology employing a particle contrast agent composition capable of rapidly staining cells in a single step. The particle contrast agent composition can be comprised of a combination of one or more particle contrast agents and one or more permeabilizing agents, optionally including one or more fixing agents and other components. The particle contrast agent composition can include Crystal Violet, 5PD-Lytic, and Proclin 300.