Multiplex Lateral Flow Assay for Differential Bacterial Viral Detection
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Solution Overview
Problem
Current multiplex lateral flow assays are inadequate for detecting multiple analytes in a single sample, particularly when one analyte is present at high concentration and another at low concentration, due to cross-reactivity and the inability to accurately quantify analytes at significantly different concentrations without sample dilution, which renders low-concentration analytes undetectable.
Innovation Solution
A lateral flow assay design with separate capture zones for each analyte, using labeled antibodies that specifically bind to their respective analytes, allowing for simultaneous detection and quantification of analytes at different concentrations without dilution, by competing with immobilized capture agents and generating distinct optical signals.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a multiplex lateral flow assay is used to detect multiple analytes in a single sample, then the detection capability for multiple analytes is improved, but cross-reactivity between antibodies and analytes occurs and measurement precision deteriorates
Solution Approach 1:
The assay is divided into separate capture zones on the test strip, with each zone dedicated to detecting a specific analyte. This spatial segmentation prevents cross-reactivity between antibodies and different analytes, as each antibody only interacts with its target analyte at its designated capture zone, thereby maintaining measurement precision while enabling multiplex detection
Solution Approach 2:
Different capture zones are designed with locally optimized properties, including specific antibody concentrations and capture agent densities tailored to each analyte's characteristics. This local optimization ensures that each analyte is detected with high precision according to its own requirements, while the overall system maintains versatility for detecting multiple analytes simultaneously
2Measurement precision
If sample dilution is performed to detect high concentration analytes, then the detection of high concentration analytes is improved, but low concentration analytes become undetectable
Solution Approach 1:
The test strip is segmented into multiple capture zones, each optimized for detecting analytes at different concentration ranges. One capture zone is designed with high sensitivity for low concentration analytes, while another is optimized for high concentration analytes. This allows simultaneous detection of both high and low concentration analytes in the undiluted sample without cross-interference
Solution Approach 2:
Different capture zones utilize different antibody concentrations, affinity constants, and capture agent densities to create distinct detection parameters for each analyte. This parameter optimization enables each zone to accurately detect its target analyte across its specific concentration range, allowing the system to handle analytes with concentrations differing by several orders of magnitude
3Ease of operation
If a single lateral flow assay is used to detect analytes at significantly different concentrations, then test simplicity is improved, but the ability to accurately quantify all analytes deteriorates
Solution Approach 1:
The lateral flow assay is segmented into multiple independent capture zones, each capable of accurately quantifying its target analyte independently. This segmentation allows the simple single-test format to maintain quantification accuracy for all analytes, as each zone operates independently without being affected by the concentration of other analytes
Solution Approach 2:
The single lateral flow assay device is designed with multi-functionality to detect and quantify multiple analytes simultaneously. Each capture zone functions as an independent detection unit, but all work together within a single test platform, providing both operational simplicity and accurate quantification for multiple analytes with different concentration ranges
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 precise detection and quantification of multiple analytes in a single sample, even when concentrations differ by several orders of magnitude, without the need for sample dilution, improving diagnostic accuracy and efficiency.
Implementation Method 1
a labeled antibody against an analyte of interest is deposited on a test strip... an antibody against the analyte binds the labeled antibody-analyte complex
Implementation Method 2
the first analyte in the fluid sample and the first complex compete to bind to the first immobilized capture agent in the first capture zone
Implementation Method 3
detecting a first signal from the first complex bound to the first immobilized capture agent in the first capture zone and a second signal from the second complex
Data Source
AI summary
Lateral flow assay devices, systems, and methods described herein measure concentration of a plurality of analytes of interest in a sample, and can determine the precise concentration of the plurality of analytes of interest, where one or more analytes of interest are present in the sample at high concentration and where one or more analytes of interest are present at low concentration. Precise concentration of each of the plurality of analytes can be determined when a single sample is applied to a single lateral flow assay in a single application, including when a first analyte of interest is present in the single sample at one-millionth the concentration of a second analyte of interest in the single sample.