Reconstituted Whole Blood Control for Device Calibration
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Solution Overview
Problem
Current methods for determining the reliability of devices measuring substance concentration in whole blood are unsatisfactory due to the instability of whole blood samples over time, leading to unreliable results, as pretreatments like freeze-drying and chemical fixing alter the sample properties and are impractical for point-of-care testing.
Innovation Solution
A method involving mixing a separated, stored cell-free blood fraction with a suspension of blood cells, both enriched with a known amount of the substance, to create reconstituted whole control blood, allowing for reliable device calibration without altering the sample's properties, and storing them at 2-8°C to maintain stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If whole control blood is stored for reliability determination, then the measurement can be performed at a later time, but the substance concentration changes over time due to metabolic processes in blood cells
Solution Approach 1:
The patent extracts the blood cells from the plasma by centrifugation and stores them separately. This separation removes the metabolic activity source (blood cells) from the plasma containing the substance to be measured, preventing concentration changes over time while allowing delayed measurement.
Solution Approach 2:
The patent performs preliminary centrifugation and separation of blood components before storage. By preparing the control blood in advance and separating it into cellular and acellular fractions, the system enables stable long-term storage with preserved measurement reliability when the fractions are recombined before analysis.
2Stability of the object's composition
If pretreatments like freeze-drying or chemical fixing are applied to whole control blood, then the storage stability is improved, but the sample properties are altered and measurements become less reliable
Solution Approach 1:
The patent removes the problematic element (blood cells with metabolic activity) from the plasma through centrifugation and separate storage. This extraction stabilizes the plasma composition without requiring chemical fixatives or freeze-drying that would alter sample properties.
Solution Approach 2:
The patent changes the physical state and storage conditions by separating components and storing them at controlled temperatures (2-8°C). This parameter change stabilizes the control blood without chemical modifications, preserving the original sample properties for accurate measurement.
3Ease of manufacture
If whole control blood is used immediately without separation, then the preparation is simple, but the substance concentration is unstable due to ongoing metabolic processes
Solution Approach 1:
The patent performs the centrifugation and separation step in advance before storage. This preliminary action, though requiring initial effort, enables simple and reliable preparation at the time of use by merely recombining the pre-separated components, ensuring both ease of operation and measurement reliability.
4Adaptability or versatility
If blood cells are present in the control sample, then it resembles actual whole blood, but the cells consume or produce substances affecting concentration stability
Solution Approach 1:
The patent extracts blood cells from plasma through centrifugation and stores them separately. This allows the plasma to remain stable without cellular metabolic activity, while the cellular component can be readded before measurement to maintain representativeness, thus resolving the contradiction between stability and adaptability.
Solution Approach 2:
The patent segments the control blood into distinct components (plasma and blood cells) that can be stored and handled independently. This segmentation allows the plasma to remain chemically stable while enabling the optional addition of cells before measurement to preserve physiological relevance.
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 maintains the stability of the substance concentration for several weeks to months, preventing changes in blood cells from affecting measurements and ensuring accurate reliability assessment of devices, even at room temperature or 37°C, thereby improving the reproducibility and practicality of point-of-care testing.
Implementation Method 1
storing them at 2-8°C to maintain stability
Implementation Method 2
mixing a separated, stored cell-free blood fraction with a suspension of blood cells
Implementation Method 3
measuring, by means of the device, the concentration of the substance in the reconstituted whole control blood
Data Source
Figure 1~2
AI summary
The present invention pertains to the field of measuring the concentration of a substance in whole blood and relates to a method for determining the reliability of a device for measuring the concentration of a substance in whole blood, and to a method for treating whole blood, wherein a cell-free blood fraction enriched with said substance and a suspension of blood cells are stored separately.