Lateral Flow Assay Cell Filtering Mechanism
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Solution Overview
Problem
Existing lateral flow assays struggle with detecting analytes in biological samples containing cells, such as red and white blood cells, due to issues like hemolysis, high background noise, low filtering efficiency, and the need for large sample volumes, which limits their effectiveness and efficiency.
Innovation Solution
A lateral flow assay system with a test strip configuration that includes a sample filter, a chromatographic strip, a conjugate pad, and absorbent pads, designed to allow detection and quantitation of analytes in small volumes while effectively filtering cells, reducing background noise, and improving efficiency by using capillary contact and specific agglutinating agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional lateral flow assays are used to detect analytes in blood samples containing red blood cells, then the assay can detect analytes, but hemolysis occurs creating high background noise and reducing measurement precision
Solution Approach 1:
The patent extracts and removes red blood cells from the blood sample before the analyte detection process. A filter is incorporated into the lateral flow device that selectively retains red blood cells while allowing plasma and analytes to pass through to the detection zone, thereby eliminating the source of background noise and hemolysis interference
Solution Approach 2:
The patent introduces an intermediary filtering mechanism between the sample application and the detection zone. This filter acts as a mediator that separates cellular components from fluid components, allowing the assay to proceed with cell-free plasma while preventing red blood cell interference with the detection chemistry
2Object-generated harmful factors
If traditional lateral flow assays filter red blood cells, then cell interference is reduced, but filtering efficiency is low resulting in cell leakage onto the chromatographic strip
Solution Approach 1:
The patent employs a porous filter material with specifically engineered pore sizes and distributions that physically retain red blood cells while permitting free passage of smaller plasma components and analytes. The porous structure provides mechanical filtration with high reliability, preventing cell leakage onto the chromatographic strip
Solution Approach 2:
The patent segments the lateral flow device into distinct functional zones: a filtration zone with the porous filter, a transition zone, and a detection zone. This segmentation ensures that cell removal occurs in a dedicated region before the sample reaches the sensitive detection area, improving overall filtering efficiency
3Ease of operation
If traditional lateral flow assays are designed for whole blood samples, then they can process blood directly, but they require relatively large sample volumes (100 μl or more)
Solution Approach 1:
The patent changes the operational parameters of the lateral flow device by incorporating a filter that enables efficient processing of smaller sample volumes. The enhanced filtration capability allows the device to achieve effective cell removal with as little as 10 μl of whole blood, representing a tenfold reduction in required sample volume while maintaining direct blood processing capability
4Adaptability or versatility
If traditional lateral flow assays process samples with cells present, then they can analyze whole blood directly, but volume variation occurs due to variation in cell volume
Solution Approach 1:
The patent extracts red blood cells from the sample before volume-critical detection steps. By removing the variable cell component through filtration, the remaining plasma volume becomes consistent and predictable, eliminating volume variation caused by differences in cell packing and cell volume among different samples
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 system enables efficient detection and quantitation of analytes in small sample volumes, is independent of sample volume variations, and effectively filters cells, providing low background noise and improved assay performance.
Implementation Method 1
The sample filter is in capillary contact with the first end of the chromatographic strip
Implementation Method 2
a first element, wherein the first element comprises a sample filter and the sample filter comprises a first pore size
Implementation Method 3
the sample filter optionally comprises an agglutinating agent
Implementation Method 4
the chromatographic strip allows lateral flow of fluid from the first end to the second end
Implementation Method 5
a fourth element, wherein the fourth element comprises an absorbent pad
Data Source
AI summary
The present invention relates to a lateral flow assay and system, including a test strip, for detection and quantification of analytes in samples, such as samples containing cells and fluid. In general, according to the present invention, a test strip for a lateral flow assay for detection of at least one analyte in a sample comprises: (1) a chromatographic strip, a sample filter, a fluid-impermeable barrier, and means for providing a mobilizable detectable agent that is capable of binding to the at least one analyte or to the capture agent after capturing the analyte to the chromatographic strip such that the mobilizable detectable agent migrates through the chromatographic strip and contacts sample that has passed through the sample filter and also has migrated through the chromatographic strip. The test strip allows detection with or without quantitation of an analyte in a sample containing whole cells.