Whole Blood Assay Binding Surface Plasma Concentration
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Solution Overview
Problem
Conventional assays for analytes in whole blood face challenges due to the presence of particulate matter, leading to inaccurate measurements and the need for complex corrections, as the concentration of analytes in whole blood is diluted by red blood cells, making it difficult to compare with established reference ranges and requiring separate steps for hematocrit correction.
Innovation Solution
A method that allows for the measurement of analyte concentration in the liquid fraction of whole blood samples without removing particulate matter or correcting for hematocrit, using a binding surface to immobilize analytes and generate signals independent of the volume occupied by particulate matter, achieving measurements that closely approximate the actual plasma concentration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional assays are used to measure analytes in whole blood, then the presence of red blood cells causes dilution of analyte concentration, but this leads to inaccurate measurements that differ from plasma concentration reference ranges
Solution Approach 1:
The patent extracts the liquid fraction (plasma) from the whole blood sample by allowing red blood cells to settle or be separated, then performs the assay only on the extracted liquid portion. This eliminates the dilution effect caused by red blood cells while avoiding complex hematocrit correction calculations, as the assay directly measures plasma concentration without interference from cellular components.
Solution Approach 2:
The patent segments the whole blood sample into two distinct phases: a liquid fraction containing the analyte and a cellular fraction containing red blood cells. By performing the assay on the separated liquid fraction, the method achieves accurate plasma concentration measurements while simplifying the overall procedure compared to traditional approaches that require hematocrit measurement and correction.
2Measurement precision
If hematocrit correction is applied to whole blood assay results, then measurement accuracy improves, but the complexity of the assay increases due to additional correction steps
Solution Approach 1:
Instead of performing hematocrit correction calculations on whole blood assay results, the patent extracts the liquid fraction by allowing red blood cells to settle or separate, then conducts the assay directly on the extracted plasma. This approach achieves accurate plasma concentration measurements while eliminating the need for complex hematocrit measurement and correction procedures, significantly simplifying the assay operation.
3Measurement precision
If filters or centrifuges are used to separate red blood cells from plasma prior to measurement, then measurement accuracy improves, but the cost and complexity of instrumentation increase significantly
Solution Approach 1:
The patent utilizes the natural density difference between red blood cells and plasma to enable spontaneous separation without requiring external equipment. By allowing the whole blood sample to settle or separate under gravity alone, the liquid fraction containing plasma rises to the top while red blood cells remain at the bottom. This self-separation mechanism achieves accurate plasma concentration measurements while eliminating the need for expensive centrifuges or filtration systems.
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 enables precise and accurate measurement of analyte concentrations in whole blood samples, reducing errors and complexity by directly measuring the plasma concentration without the need for hematocrit correction, with results differing by no more than 20%, 10%, 5%, 2%, 1%, or 0.5% from the actual plasma concentration.
Implementation Method 1
using a binding surface to immobilize analytes and generate signals independent of the volume occupied by particulate matter
Data Source
AI summary
Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.


