Whole Blood Coagulation Control Using Erythrocyte Lysate
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Solution Overview
Problem
Current blood coagulation controls lack erythrocyte components, making them inadequate for whole blood coagulation tests, especially for point-of-care testing, as they do not resemble actual whole blood samples closely enough.
Innovation Solution
A stable whole-blood-based control is prepared by lysing erythrocytes isolated from whole blood, washing to remove platelets and leukocytes, and combining the lysate with platelet-free buffered plasma and an antimicrobial agent, which can be lyophilized and reconstituted to maintain clotting activity for several hours or days.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If plasma-based controls are used for coagulation testing, then the control can be stored stably, but the control lacks erythrocyte components and does not resemble whole blood samples
Solution Approach 1:
The patent creates a composite control system combining plasma-based stability with erythrocyte-based representativeness. The control composition includes plasma, erythrocytes, and antimicrobial agents, merging the advantages of both components to achieve both stability and whole-blood representativeness simultaneously.
Solution Approach 2:
The patent modifies the physical and chemical parameters of the control composition by adjusting erythrocyte concentration, plasma composition, and antimicrobial agent levels to optimize both stability and representativeness. Lyophilization is used to change the physical state for stable storage while maintaining biological activity.
2Measurement precision
If whole blood controls are used to maintain representativeness, then the control resembles actual samples, but the control lacks stability for extended storage
Solution Approach 1:
The patent extracts the unstable erythrocyte component from fresh whole blood and incorporates it into a controlled composition with plasma and antimicrobial agents. This extraction allows the erythrocytes to be used in a stabilized formulation that maintains representativeness while improving storage stability through controlled conditions and lyophilization.
Solution Approach 2:
The patent performs preliminary stabilization actions by adding antimicrobial agents and controlling the composition before storage. The control composition is prepared in advance with all necessary components (plasma, erythrocytes, antimicrobials) already in place, allowing stable storage while maintaining whole-blood representativeness.
3Device complexity
If controls without antimicrobial agents are used, then the composition is simpler, but microbial contamination occurs during storage
Solution Approach 1:
The patent converts the potential harm of microbial contamination into a benefit by carefully selecting and dosing antimicrobial agents that prevent contamination without interfering with coagulation testing. The antimicrobial agents are included at concentrations that provide protection while maintaining test accuracy.
Solution Approach 2:
The patent optimizes the concentration and type of antimicrobial agents to achieve the minimum effective level for preventing contamination while minimizing interference with coagulation factors. The physical and chemical parameters of the antimicrobial addition are carefully controlled to maintain composition simplicity and functional integrity.
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 resulting control composition retains clotting activity and can be adjusted to desired levels, providing a more accurate and stable alternative for monitoring blood coagulation assays, suitable for both open-vial and closed-vial storage conditions.
Implementation Method 1
The cells are sonicated to lyse the erythrocytes
Implementation Method 2
The resulting control composition may be lyophilized and reconstituted with saline
Data Source
AI summary
A whole-blood-based substitute composition that is useful in coagulation assays as a standard, reference, control, calibrator, linearity verifier, or training material is prepared by combining a red blood cell lysate that is free of plasma, leukocytes, and platelets with a platelet-free plasma of human origin and an antimicrobial agent.