Calibration Fluids With Synthetic Beads for Stable Hematology Analysis
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Solution Overview
Problem
Current calibration and quality control fluids for hematologic analysis have high lot-to-lot variability, particularly in white blood cell counting and platelet size parameters, necessitating more stable and reliable solutions for automated hematology analyzer systems.
Innovation Solution
The use of calibration fluids comprising beads of specific sizes and colors, optionally with stabilized blood cells, to mimic biological samples, allowing for calibration and quality control in automated hematology analyzers by simulating the processes of printing, fixation, and staining.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If automated systems use current calibration fluids made from biologic material, then calibration can be performed, but high lot-to-lot variability occurs in white blood cell counting and platelet size parameters
Solution Approach 1:
The patent replaces biologic calibration materials with synthetic bead copies that mimic the physical and optical properties of blood cells. These beads are engineered to match cell sizes, shapes, and staining characteristics, providing consistent calibration standards that eliminate lot-to-lot variability while maintaining measurement accuracy for white blood cell counting and platelet sizing
Solution Approach 2:
The invention changes the fundamental parameters of calibration materials from biologic origin to synthetic composition. By controlling bead size, material density, and surface properties, the system achieves precise and repeatable calibration parameters for cell counting and sizing without the variability inherent in biologic materials
2Ease of operation
If manual sample preparation is used, then flexibility is maintained, but quality variations occur due to differences in technician skill and experience
Solution Approach 1:
The calibration system is designed to be self-calibrating using automated bead analysis. The system automatically processes synthetic bead samples through the same workflow as clinical samples, eliminating manual intervention and the associated variability from technician skill differences while maintaining operational flexibility
3Adaptability or versatility
If manual sample preparation procedures are used, then adaptability is maintained, but processing speed decreases due to multiple labor-intensive steps
Solution Approach 1:
The patent replaces manual mechanical preparation steps with automated fluid handling and imaging systems. Synthetic beads are processed through automated loading, staining, and imaging workflows, eliminating labor-intensive manual steps while maintaining the adaptability to process various sample types at increased speed
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 beads in these fluids enable consistent calibration and quality control, reducing variability and enhancing the performance of automated hematology analyzers by ensuring accurate cell counting and sizing, while being cost-effective and stable.
Implementation Method 1
the beads in these fluids can be attached or adhered to the glass or plastic substrates
Data Source
AI summary
The disclosure features calibration fluids that include a plurality of beads, such as cellulose, silica, poly(methyl-methacrylate) (PMMA), melamine, cross-linked agarose, polyvinylacetate (PVA), and/or polystyrene beads, where the beads are sized and colored to represent at least one type of blood cell; and a carrier fluid, that can include a polymer or polymerizing matrix, e.g., a water-soluble resin, e.g., an acrylic or polyurethane water-soluble resin or a starch or a cellulose, serum, and/or one or more or sugars. The disclosure also features methods of using the calibration fluids to calibrate automated sample preparation systems, such as automated hematology analyzer systems, e.g., image-based hematology analyzer systems.