Lateral Flow Assay Merging Multiple Pathogen Proteins on Single Test Line
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Solution Overview
Problem
Existing lateral flow assays (LFAs) for detecting pathogen exposure generate false negatives due to low sensitivity, as they typically detect only one specific protein of a pathogen, missing immune responses to other proteins.
Innovation Solution
The LFA device is configured with a conjugate pad containing tagged binding reagents to multiple immunoglobulins, and test lines immobilizing a combination of proteins from the target pathogen, allowing capture of IgM or IgG responses regardless of the specific protein involved, thereby increasing sensitivity and reducing false negatives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lateral flow assay detects only one specific protein of a pathogen, then the test structure remains simple and easy to manufacture, but the sensitivity is low and false negatives occur
Solution Approach 1:
The patent combines multiple different pathogen proteins onto a single test line of the lateral flow assay. Instead of using separate test lines for each protein, the invention merges multiple proteins (e.g., viral antigens) into one location, allowing simultaneous detection of immune responses to multiple proteins while maintaining a simple test structure and avoiding the need for multiple separate assays.
2Reliability
If multiple test lines are used to detect different proteins, then the sensitivity increases, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The invention merges multiple detection functions into a single test line by immobilizing multiple different pathogen proteins on the same membrane strip. This approach maintains high detection accuracy for multiple proteins while significantly simplifying the manufacturing process compared to producing and assembling multiple separate test lines, each requiring precise alignment and calibration.
3Reliability
If a single protein is detected, then the assay is easy to operate and interpret, but the reliability is reduced due to false negatives from missing other protein responses
Solution Approach 1:
The patent combines multiple pathogen proteins into one test line, enabling simultaneous detection of various immune responses in a single assay run. This maintains operational simplicity for the user while dramatically improving diagnostic reliability by capturing multiple protein-specific immune responses that would otherwise be missed by single-protein assays, thereby reducing false negatives.
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 configuration enhances the sensitivity of the test, reducing false negatives by allowing detection of immune responses to multiple proteins of the target pathogen, and ensuring that any immune response is captured, leading to a more reliable diagnostic outcome.
Implementation Method 1
A sample pad is used to receive a quantity of fluid (referred to as the sample fluid) and transport the sample fluid to an adjacent conjugate pad
Implementation Method 2
As the immunocomplex moves over the test area, the immunocomplex binds with the immobilized antibody on the test area, resulting in a colored test line
Implementation Method 3
the control line may contain an immobilized antibody that binds to the free antibodies labeled with the detector resulting in a colored control line
Data Source
AI summary
A lateral flow assay device includes a test strip that is configured to receive a sample fluid and detect a presence of antibodies to one or more of a plurality of proteins of the target pathogen. The lateral flow assay device includes a conjugate pad and a membrane. The conjugate pad contains a plurality of the proteins of the target pathogen, each conjugated with a label. If the sample fluid contains antibodies that are specific to the target pathogen through any of the target pathogen's proteins, a binding takes place between those antibodies and the corresponding tagged protein. The membrane may include a plurality of test lines. Each test line may contain the immobilized binding reagent to one antibody class, resulting in the concentration of all the molecules of that antibody class on the test line.