Single-Substrate Rapid Detection Tests for Faster RDT Manufacturing
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Solution Overview
Problem
Existing rapid detection tests (RDTs) are time-consuming and expensive due to the fabrication of multiple substrates and require lengthy immunoglobulin antibody screening, limiting their availability for emerging pathogens.
Innovation Solution
A single substrate functionalized with a coupling agent and bioorthogonal tethered proteins, including tetrazine-modified proteins, is used to create test and control regions, allowing for rapid and cost-effective manufacturing of RDTs through digital printing and automated techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple substrates are fabricated for RDT manufacturing, then sensitivity and specificity are maintained, but manufacturing time and costs increase
Solution Approach 1:
The patent combines multiple substrate functions into a single substrate by integrating test regions, control regions, and sample application areas onto one nitrocellulose membrane. This merging eliminates the need for separate substrate fabrication and assembly steps, reducing manufacturing time while maintaining detection reliability through proper regional functional design
Solution Approach 2:
The single substrate is designed to perform multiple functions simultaneously: it serves as the capture surface for antibodies, the migration pathway for samples, the control mechanism region, and the detection zone. This multi-functionality approach maintains comprehensive detection capabilities while streamlining manufacturing processes
2Measurement precision
If multiple substrates are fabricated for RDT manufacturing, then detection sensitivity is maintained, but manufacturing costs increase
Solution Approach 1:
By merging multiple substrate functions into one, the patent reduces material costs, labor costs for assembly, and quality control expenses associated with handling multiple separate substrates. The single substrate approach maintains detection sensitivity through optimized antibody placement and regional design
Solution Approach 2:
The patent employs colorimetric detection using gold nanoparticles that change color based on analyte presence, providing visual detection without requiring additional instrumentation. This approach maintains high detection sensitivity while reducing costs by eliminating expensive electronic detection systems
3Reliability
If lengthy immunoglobulin antibody screening is performed, then detection specificity is improved, but development time increases
Solution Approach 1:
The patent performs preliminary antibody screening and validation during the substrate fabrication process itself, rather than requiring separate lengthy screening phases. Antibodies are screened for specificity and affinity while being immobilized on the nitrocellulose substrate, integrating quality control into manufacturing and accelerating development
Solution Approach 2:
The patent uses recombinant antibodies and antibody fragments that can be rapidly produced through genetic engineering and expressed in bacterial or mammalian cell systems. This copying approach through molecular biology techniques accelerates antibody development compared to traditional hybridoma methods
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 approach reduces manufacturing time and costs while maintaining sensitivity and specificity, enabling early detection of pathogens with improved signal detection and reduced cross-reactivity.
Implementation Method 1
A single substrate functionalized with a coupling agent and bioorthogonal tethered proteins
Implementation Method 2
bioorthogonal tethered proteins, including tetrazine-modified proteins
Implementation Method 3
detection particles configured to bind to at least one of a target analyte and control agents
Data Source
AI summary
Examples are directed to rapid detection test (RDT) devices, apparatuses, and method of forming RDT device and/or apparatuses that include substrates functionalized with a coupling agent. An example RDT apparatus comprises a substrate at least partially coated with a coupling agent having functional groups, a test region disposed on a first portion of the substrate, the test region including a set of capture agents configured to bind to a target analyte in a biological sample, a control region disposed on a second portion of the substrate, the control region including a set of control agents, each of the control agents including an analyte protein, and a set of detection particles that exhibit a detectable label, each of the detection particles configured to bind to at least one of the target analyte or the analyte protein of the set of control agents.