Lateral Flow Plasma Assay With Integrated Hematocrit Correction
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Solution Overview
Problem
Existing methods for determining analyte concentration in whole blood samples face challenges in accurately measuring hematocrit (Hct) interference, requiring external equipment, reagents, or sample denaturation, which complicates simultaneous or sequential measurements of Hct and analytes.
Innovation Solution
A lateral flow assay method that determines Hct by diluting the sample with a non-hemolysing buffer, applying it to a substrate, imaging, and correlating image parameters with known Hct values to calculate analyte concentration without auxiliary equipment or reagents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If external equipment, reagents, or sample denaturation are used to determine Hct, then Hct measurement capability is achieved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent combines Hct determination and analyte measurement into a single lateral flow assay device. The Hct determination is integrated by utilizing the same substrate and imaging system, eliminating the need for separate external equipment. The device measures both Hct and analyte concentration in one unified platform, resolving the contradiction by merging functions rather than adding complexity.
Solution Approach 2:
The lateral flow assay substrate performs self-service by simultaneously providing the platform for both Hct determination and analyte measurement. The substrate's optical properties and flow characteristics are exploited to derive Hct information without requiring additional reagents or external intervention, allowing the system to determine multiple parameters using its inherent capabilities.
2Measurement precision
If multiple measurements (Hct and analyte) are performed sequentially or separately, then measurement completeness is achieved, but measurement precision and time efficiency worsen
Solution Approach 1:
The patent merges Hct determination and analyte measurement into simultaneous operations within the same lateral flow assay. Both measurements are performed on the same substrate using the same sample application and imaging process, eliminating sequential measurement delays and improving time efficiency while maintaining precision for both parameters.
Solution Approach 2:
The lateral flow assay device is designed with multi-functionality to perform both Hct determination and analyte measurement. The substrate and imaging system are universally applicable to both measurement types, allowing parallel or simultaneous operation without requiring separate procedures, thereby reducing total measurement time while preserving accuracy.
3Difficulty of detecting and measuring
If sample denaturation is used to determine Hct, then Hct measurement is achieved, but analyte integrity and measurement precision worsen
Solution Approach 1:
The patent extracts Hct information from the sample without causing denaturation. By utilizing the optical properties of intact red blood cells in the lateral flow assay and correlating image parameters with known Hct values, the method determines Hct while keeping the sample in its native state, thereby preserving analyte integrity and measurement precision.
Solution Approach 2:
The lateral flow substrate acts as an intermediary that enables Hct determination through optical imaging without requiring sample denaturation. The substrate's interaction with the sample provides sufficient contrast to measure Hct while maintaining sample integrity, serving as a mediator between Hct detection and analyte preservation.
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 method improves analyte measurement precision by integrating Hct determination directly in a lateral flow assay, maintaining high accuracy and simplicity.
Implementation Method 1
taking an image of the substrate within 1-600 seconds from when the applied sample has been absorbed in the substrate; analysing the image to determine a value of at least one parameter from the image; correlating the value to values obtained for samples having known hematocrit values
Data Source
AI summary
The precision of a lateral flow assay for determining the concentration of an analyte in the plasma fraction of a sample of whole blood can be significantly improved by applying an integrated step for determining the hematocrit of the optionally diluted sample, and taking both hematocrit and dilution factor into account when calculating the concentration of the analyte. This is made possible inter alia by using a predetermined wavelength when taking an image of the sample after application to a substrate in the lateral flow assay device, and wherein said wavelength is selected based on the dilution factor used. This hematocrit measurement is advantageously integrated in lateral flow assay methods and devices for the measurement of an analyte in plasma and contributes significantly to an improved precision of such assays.