Micro-bead Control Material for Cell Analyzer Calibration
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Solution Overview
Problem
Traditional Complete Blood Count (CBC) systems face challenges with stabilization and degradation of blood samples, leading to inaccurate results and high costs due to the need for refrigerated storage and short shelf life of control materials, which can cause strain on laboratories and clinics.
Innovation Solution
A microscopy-based cell imaging and counting system using a mixture of micro-beads with known characteristics, including fluorescent and differently sized beads, to simulate blood cells, which can be used for calibration and quality control, eliminating the need for refrigerated storage and extending shelf life, and reducing costs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional stabilized blood control materials are used, then quality control can be performed regularly, but the materials require refrigerated storage and have short shelf life
Solution Approach 1:
The patent uses synthetic beads that replicate the physical and optical properties of blood cells (size, shape, refractive index) to create a control material that mimics fresh blood samples. These beads are enclosed in freeze-dried capsules that preserve them indefinitely without refrigeration, solving the shelf life problem while maintaining QC accuracy.
Solution Approach 2:
The patent transforms the control material from fresh stabilized blood to synthetic beads with controlled physical parameters (size distribution 1-20 micrometers, specific refractive indices, fluorescent properties). This parameter transformation enables long-term storage at room temperature while preserving the ability to simulate various blood cell conditions for quality control.
2Reliability
If traditional stabilized blood control materials are used, then calibration can be performed, but the costs are high due to refrigeration requirements
Solution Approach 1:
The patent replaces expensive stabilized blood products with synthetic beads that can be manufactured at lower cost. The beads are produced in bulk and encapsulated in freeze-dried format, eliminating the need for expensive refrigeration infrastructure and reducing shipping costs while maintaining calibration accuracy.
Solution Approach 2:
The patent uses disposable freeze-dried capsules containing synthetic beads that can be stored indefinitely without special conditions. This eliminates the need for expensive refrigeration equipment and reduces ongoing storage costs, making the control material economically viable for routine laboratory use.
3Measurement precision
If stabilized blood control materials are used, then cell counting and classification can be simulated, but the metaproperties do not exactly match fresh human blood
Solution Approach 1:
The patent creates synthetic beads with locally controlled properties - different bead types with specific sizes (1-20 micrometers), shapes, and refractive indices are used to simulate different blood cell types. Each bead category can be precisely controlled to match the metaproperties of specific cell types, enabling accurate simulation of various blood conditions.
Solution Approach 2:
The patent uses composite control materials combining synthetic beads with fluorescent markers and encapsulating matrices. The beads themselves are composite structures with controlled internal properties, and they are combined with fluorescent dyes and placed in freeze-dried capsule matrices, creating a multi-component system that accurately replicates fresh blood characteristics.
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 system provides improved operator and system control, longer shelf-life, and lower costs compared to traditional CBC QC materials, ensuring accurate calibration and quality control without the need for cold-chain shipping or refrigeration.
Implementation Method 1
The mixture of micro-beads can include at least some fluorescent micro-beads
Data Source
AI summary
This disclosure relates to verifying the operation of cell analyzers, including microscope-based cell imaging and counting analyzers. In one general aspect, a mixture of micro-beads having known characteristics is introduced into the analyzer. One or more images of the mixture are acquired with the analyzer's microscope, the images are analyzed, and a determination is made about whether results meet one or more predetermined quality control thresholds. Also disclosed is a hematology control material that can be used to perform the verification and includes a solvent, a dye dissolved in the solvent, and micro-beads suspended in the solvent. In another general aspect, a quality control method for the analyzers includes capturing images of samples that include patient cells using at least a microscope, extracting sample-specific information about properties of the patient samples from the images, and testing information from the samples against predetermined standards to verify the operation of the analyzer.