Lateral Flow Device for Minor Cell Population Detection
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Solution Overview
Problem
Current methods for detecting minor cell populations in heterogeneous cell populations, such as in fetomaternal hemorrhage, are cumbersome, require numerous reagents and expensive instruments, and lack sensitivity, making it difficult to detect low concentrations of analytes and determine hematocrit values efficiently.
Innovation Solution
A method using a lateral flow device with a porous membrane and multiple indicator zones that interact with cellularly bound analytes, allowing for the concentration and quantification of minor cell populations, and enabling the detection of low-concentration analytes and mixed-field reactions with increased sensitivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional blood group-serology assays or FMH detection assays (Rosette Test, Kleihauer-Betke Test, Flow Cytometry) are used to detect minor cell populations, then detection capability is achieved, but the methods require numerous reagents, expensive instruments, trained personnel, and are time-consuming
Solution Approach 1:
The patent extracts and isolates the detection function from complex laboratory instruments to a simple lateral flow device that can be performed at the point of care. The device takes out only the essential detection capability while eliminating the need for expensive flow cytometers, microscopes, and centrifuges required by conventional methods.
Solution Approach 2:
The lateral flow device is designed as a disposable, single-use unit that eliminates the need for expensive, reusable instruments. Each device is self-contained with pre-applied reagents and requires no complex equipment, making it economically viable for routine use while maintaining detection sensitivity.
2Reliability
If conventional assays are used to detect fetomaternal hemorrhage, then detection is possible, but the methods are time-consuming and require numerous reagents
Solution Approach 1:
The lateral flow device has reagents pre-applied to the membrane during manufacturing, including capture antibodies and detection antibodies positioned at specific zones. This preliminary preparation eliminates the need for multiple manual reagent additions and incubation steps required by conventional assays, reducing detection time while maintaining accuracy.
Solution Approach 2:
The device uses a rapid lateral flow mechanism that quickly transports the sample through multiple detection zones in sequence, skipping the time-consuming sequential steps of conventional methods. The sample flows continuously through capture and detection zones without requiring intermediate processing steps.
3Reliability
If standard anti-D therapy doses are administered, then protection is achieved for small FMH, but protection is insufficient for larger FMH volumes
Solution Approach 1:
The lateral flow device provides quantitative feedback on the actual volume of FMH by measuring the concentration of fetal cells in the maternal blood sample. This feedback allows clinicians to determine the appropriate anti-D dosage based on measured cell concentration rather than administering fixed standard doses, ensuring adequate protection while avoiding unnecessary over-dosing.
4Measurement precision
If flow cytometry is used to detect fetal cells, then detection sensitivity is improved, but the device cost and operational complexity increase significantly
Solution Approach 1:
The lateral flow device creates a simplified copy of the flow cytometry detection principle, using antibody-antigen binding and visual detection instead of complex optical systems. The device replicates the essential function of detecting fetal cells through antibody specificity while eliminating the need for expensive flow cytometers, lasers, and sophisticated data analysis 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
The method enables the detection of minor cell populations at concentrations as low as 0.1-0.2% and allows for simultaneous detection of both cell populations in mixed-field reactions, improving sensitivity and reducing the need for complex equipment and trained personnel.
Implementation Method 1
a porous membrane (2) that is suitable for being penetrated by cellular components
Implementation Method 2
at least one absorption area (3) on the membrane, which absorbs the liquid after the latter has passed the indicator zones
Data Source
AI summary
The invention relates to a method for determining one or more cellularly bound analytes in a liquid sample, said method being carried out using a device comprising: at least one feeding zone (5) for applying the liquid sample; a porous membrane (2) that is suitable for letting cellular components penetrate therethrough and includes at least one indicator zone on the membrane, said indicator zone being able to interact with the cellularly bound analyte and containing at least one binding element against the cellularly bound analyte; and at least one absorption area (3) on the membrane, which absorbs the liquid after the liquid has passed the indicator zones. The at least one indicator zone lies between the feeding zone (5) and the absorption area (3). The method is carried out for concentrating and quantifying the minor cell population in heterogeneous cell populations, for example in cases of fetomaternal hemorrhage or in chimera, detecting an analyte provided at a low concentration on cells, determining the hematocrit value, and/or determining, in parallel, cellularly bound analytes in mixed-field reactions.