Multiplexed Vertical Flow Cassette for Early Lyme Disease Detection
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Solution Overview
Problem
Current Lyme disease diagnostic tests, particularly the two-tier serological testing method, face challenges such as poor sensitivity in early-stage detection, high costs, long turnaround times, and limited accessibility due to the need for centralized facilities and expensive equipment, which restricts timely and accurate diagnosis, especially in rural areas.
Innovation Solution
A multiplexed vertical flow immunodiagnostic assay (xVFA) system powered by deep learning, utilizing a stack of functional porous layers and a portable reader device, allows for rapid detection of multiple Lyme disease-specific antibodies on a single sensing membrane, enabling early-stage diagnosis with improved sensitivity and specificity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If two-tier serological testing method is used, then specificity is improved (>98%), but sensitivity in early-stage detection deteriorates (seldom exceeding 50%)
Solution Approach 1:
The patent segments the testing process into two separate cassettes: first-tier cassette for initial antibody detection and second-tier cassette for confirmatory testing. This segmentation allows the first tier to use a limited antigen panel for rapid screening while the second tier provides confirmatory testing, thereby maintaining high specificity while improving early-stage sensitivity through the expanded antigen panel in the first tier.
Solution Approach 2:
The patent transitions from traditional centralized laboratory testing to a distributed point-of-care testing model using portable cassettes and mobile imaging devices. This dimensional change from centralized to decentralized testing enables early-stage detection in rural and remote areas, improving sensitivity by making testing accessible when patients first seek care rather than requiring travel to centralized facilities.
2Reliability
If two-tier testing method is used, then diagnostic accuracy is improved, but turnaround time deteriorates (>24 hours)
Solution Approach 1:
The patent merges the first-tier and second-tier testing into a single point-of-care platform that can process both tiers in one visit. The system combines the antigen panels and testing protocols of both tiers into integrated cassettes, allowing clinicians to complete both screening and confirmatory testing during a single patient encounter, thereby reducing turnaround time from >24 hours to immediate results while maintaining diagnostic accuracy.
Solution Approach 2:
The patent performs preliminary action by enabling first-tier testing at the point of care before patients are referred to centralized laboratories. This preliminary detection and triage allows clinicians to identify suspected cases immediately and initiate appropriate workup or treatment planning, reducing the overall turnaround time while maintaining the two-tier diagnostic accuracy through subsequent confirmatory testing.
3Reliability
If two-tier testing method is used, then diagnostic reliability is improved, but cost deteriorates (>$400/test)
Solution Approach 1:
The patent employs disposable paper-based cassettes for both first-tier and second-tier testing that can be discarded after single use. These low-cost paper substrates replace expensive reusable laboratory equipment and reagents, enabling the two-tier testing protocol to be performed at a fraction of the traditional cost while maintaining diagnostic reliability. The cassettes are designed for single-use portability, eliminating the need for expensive centralized laboratory infrastructure.
4Reliability
If two-tier testing method is used, then diagnostic accuracy is improved, but accessibility deteriorates (requires centralized facilities)
Solution Approach 1:
The patent extracts the essential two-tier testing functionality from centralized laboratory settings and packages it into portable, self-contained cassettes that can be used at the point of care. By taking out the antigen panels, reagents, and testing protocols from the laboratory environment and encapsulating them in field-deployable formats, the system maintains diagnostic accuracy while enabling accessibility in rural, remote, and resource-limited settings where centralized facilities are unavailable.
Solution Approach 2:
The patent introduces mobile imaging devices and portable readers as intermediaries between the paper-based cassettes and diagnostic interpretation. These intermediary tools enable the cassettes to function autonomously at point of care without requiring centralized laboratory equipment, bridging the gap between simple paper-based testing and sophisticated diagnostic accuracy, thereby improving accessibility while maintaining reliability.
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 achieves a sensitivity and specificity of 90.5% and 87.0%, respectively, for early-stage Lyme disease detection, reducing costs and enabling rapid, point-of-care diagnostics, with potential for increased accessibility and improved treatment outcomes.
Implementation Method 1
a stack of functional porous layers
Implementation Method 2
sensing membrane having a plurality of immunoreaction spots or locations formed therein
Data Source
AI summary
A multiplexed vertical flow serodiagnostic testing device for diseases such as Lyme disease includes one or more multi-piece cassettes that include vertical stacks of functionalized porous layers therein. A bottom piece of the cassette includes a sensing membrane with a plurality of spatially multiplexed immunoreaction spots or locations. Top pieces are used to deliver sample and/or buffer solutions along with antibody-conjugated nanoparticles for binding with the immunoreaction spots or locations. A colorimetric signal is generated by the nanoparticles captured on the sensing membrane containing disease-specific antigens. The sensing membrane is imaged by a cost-effective portable reader device. The images captured by the reader device are subject to image processing and analysis to generate positive (+) or negative (−) indication for the sample. A concentration of one or more biomarkers may also be generated. The testing device is rapid, simple, inexpensive, and allows for simultaneous measurement of multiple antibodies and/or antigens making it an ideal point-of-care platform for disease diagnosis.