Lateral Flow Assay Red Blood Cell Separation via Physical Barriers
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Solution Overview
Problem
Existing methods for analyzing whole blood samples are hindered by the interference of red blood cells, which can lead to inaccurate or inconsistent results in chromogenic and nonchromogenic assays, and require additional processing steps such as centrifugation or clotting, which are time-consuming and cumbersome.
Innovation Solution
The use of devices with a sample receiving zone that physically interacts with red blood cells, such as a net or mesh, and/or non-lytic hemagglutination agents like antibodies or lectins to trap and retain red blood cells without lysis, allowing for accurate separation and analysis of plasma or serum without additional processing steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If red blood cells are separated from plasma or serum using conventional methods (centrifugation or clotting), then accurate analysis of whole blood samples is achieved, but the process becomes time-consuming and cumbersome
Solution Approach 1:
The patent extracts and removes red blood cells from the whole blood sample using a physical barrier (filter or membrane) in the lateral flow assay device. This extraction step separates the red blood cells from the plasma/serum fraction that contains the analyte, enabling accurate detection without requiring time-consuming centrifugation or clotting procedures.
Solution Approach 2:
The patent introduces an intermediary physical barrier (filter or membrane structure) within the lateral flow assay device that mediates the separation process. This intermediary component enables red blood cell removal through passive filtration as the sample flows through the device, eliminating the need for active processing steps like centrifugation.
2Measurement precision
If red blood cells are present in the sample during chromogenic assays, then the deep red color interferes with the test results, but removing red blood cells requires additional processing steps
Solution Approach 1:
The patent merges the red blood cell separation function with the lateral flow assay testing function into a single integrated device. The physical barrier is incorporated directly into the assay strip structure, allowing red blood cell removal and analyte detection to occur simultaneously in one operation, rather than requiring separate processing steps.
Solution Approach 2:
The lateral flow assay device performs self-service by automatically separating red blood cells from the sample as it flows through the physical barrier during the test. The device structure itself provides the separation function without requiring external processing equipment or additional user actions, simplifying the overall process.
3Reliability
If physical means (net or mesh) are used to capture red blood cells, then red blood cells are retained without lysis, but the device structure becomes more complex
Solution Approach 1:
The patent employs porous materials (filters or membranes) with controlled pore sizes that physically trap red blood cells while allowing plasma and smaller analyte molecules to pass through. The porous structure provides effective separation based on size differences, maintaining red blood cell integrity without requiring complex mechanical components.
Solution Approach 2:
The patent uses thin film or shell-like filter structures that form the physical barrier for red blood cell capture. These thin film structures provide effective filtration with minimal bulk, maintaining device simplicity while achieving reliable red blood cell separation through their porous architecture.
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
Enables safe, accurate, and economical analysis of whole blood samples by effectively separating red blood cells from plasma or serum, reducing the need for complex equipment and procedures, and providing reproducible results.
Implementation Method 1
the sample pad may also comprise a non-lytic hemagglutination agent, wherein the hemagglutination agent captures red blood cells from an applied whole blood sample in the sample receiving zone without lysis of the red blood cells
Data Source
AI summary
Devices, methods and kits including a means for capturing red blood cells are provided. Such means include physical means for trapping red blood cells as well as agglutination agents, including hemagglutination agents, for retaining red blood cells in certain regions of the devices described herein. The physical means and agglutination agents provide separation of red blood cells from whole blood samples. Analysis of separated and/or agglutinated whole blood samples for the presence or absence of analytes of interest can be performed without interference from red blood cells. Devices, such as lateral flow assays with sample receiving zones comprising physical means and/or agglutination agents are also described. Certain agglutination agents include lectins and antibodies. such as red blood cell binding antibodies.