Nucleated Red Blood Cell Simulating Particles for Hematology Analyzer Quality Control

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Solution Overview

Problem

Current methods for producing nucleated red blood cell simulating particles are complex and costly, and existing particles are not suitable for simulating the fluorescent properties of human nucleated red blood cells using fluorescent-scattered light methods, as they either lack nuclei or have morphological differences that affect detection accuracy.

Innovation Solution

A method involving leukocytes or leukocyte subpopulations bound to fluorescent staining inhibitors that stably bind to nuclei or nucleic acids, reducing the binding capacity of fluorescent dyes, thereby simulating the fluorescent properties of nucleated red blood cells without using nucleic acids or biological polymers, and are suitable for use in hematology analyzers employing fluorescent-scattered light detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional methods are used to produce nucleated red blood cell simulating particles, then the particles can be manufactured, but the production process becomes complex and costly

Engineering Contradiction:
Improvesimulation accuracyVSAvoidproduction complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses animal red blood cells (which naturally contain nuclei) as simple copies to simulate human nucleated red blood cells, avoiding the need for complex synthetic particle production while achieving accurate simulation of fluorescent properties and morphological characteristics

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent changes the key parameter of having a nucleus by selecting animal red blood cells that naturally possess nuclei, thereby transforming the simulation approach from synthetic particle construction to using naturally occurring cells with appropriate nuclear characteristics

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If traditional particles are used, then production is simpler, but they lack nuclei or have morphological differences that affect detection accuracy

Engineering Contradiction:
Improveproduction simplicityVSAvoiddetection accuracy
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent uses animal red blood cells as natural copies that inherently possess nuclei and appropriate morphological characteristics, thereby achieving both production simplicity and detection accuracy without requiring complex synthetic construction

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent employs readily available animal blood as a simple, cost-effective material source that can be easily prepared and used for quality control purposes, replacing expensive and complex synthetic particle systems

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Measurement precision

If fluorescent dyes bind strongly to nuclei, then detection sensitivity increases, but it becomes difficult to simulate the fluorescent properties of nucleated red blood cells accurately

Engineering Contradiction:
Improvefluorescent detection sensitivityVSAvoidsimulation accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent uses animal red blood cells as an intermediary that naturally contains nuclei with appropriate fluorescent binding characteristics, mediating between the fluorescent dye and the simulation requirement to achieve both sensitivity and accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the nuclear content parameter by selecting animal red blood cells with nuclei, thereby achieving appropriate fluorescent binding characteristics that simultaneously provide detection sensitivity and simulation accuracy

Inventive Principle:
Principle #35Parameter changes

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

The method provides a simple, cost-effective way to produce nucleated red blood cell simulating particles that accurately mimic the fluorescent and scattered light characteristics of human nucleated red blood cells, enhancing the quality control of blood cell analyzers by allowing distinct differentiation and counting of nucleated red blood cells.

Implementation Method 1

a blood cell analyzer which detects via fluorescent-scattered light methods

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

detects via fluorescent-scattered light methods

Methodology Applied
Scientific EffectLight scattering: Scattering

Data Source

PatentUS9995736B2Preparation and use of nucleated red blood cell simulating particles and hematology control mixtures
Publication Date: 2018.06.12 SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
  • US9995736B2 patent drawing
  • US9995736B2 patent drawing
  • US9995736B2 patent drawing

AI summary

The present disclosure provides a nucleated red blood cell simulating particle, which may be leukocytes bound to a fluorescent-staining inhibitor capable of stably binding to the nucleus or a nucleic acid in a cell so as to reduce the binding capacity of the particles to a fluorescent dye during their detection. The present disclosure also provides a method for preparing nucleated red blood cell simulating particles, including the following steps: (a) obtaining purified leukocytes; (b) suspending the leukocytes in a cell treatment solution containing a fluorescent-staining inhibitor which stably binds to the nucleus or a nucleic acid in a cell, and (c) washing the obtained product. The present disclosure also provides a hematology control mixture containing the nucleated red blood cell simulating particles. In addition, the present disclosure describes the use of the nucleated red blood cell simulating particles and the hematology control mixtures comprising the same, for the quality control of a blood cell analyzer.