Affinity Filamentous Material for Lyme Disease Biomarker Capture
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Solution Overview
Problem
Current methods for diagnosing diseases using biomarkers in biofluids, such as ELISA, PCR, and IHC, face challenges including limited specificity, sensitivity, and cross-reactivity, along with longer turnaround times and variability due to pre-analytical factors.
Innovation Solution
The development of a method involving a filamentous material functionalized with affinity agents specific to biomarkers, allowing for the direct identification and sequencing of peptides derived from pathogenic strains of Borrelia in urine and other bodily fluids, using a non-invasive process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional methods such as ELISA, PCR, and IHC are used for biomarker detection, then the diagnostic process can be performed with established protocols, but the sensitivity and specificity are limited and cross-reactivity occurs
Solution Approach 1:
The patent extracts and isolates specific biomarkers from complex biological fluids using affinity agents that selectively bind to target molecules. This extraction process separates the biomarkers of interest from the background matrix, enabling highly specific detection without cross-reactivity interference from other proteins or molecules in the sample.
Solution Approach 2:
The patent introduces affinity agents as intermediary molecules that mediate between the biomarkers and detection systems. These affinity agents serve as selective mediators that bridge the target biomarkers and the detection apparatus, enhancing both sensitivity and specificity by providing a highly specific binding interface that conventional methods lack.
2Productivity
If conventional biomarker detection methods are used, then the process can be performed with standard equipment, but the turnaround time is longer and variability due to pre-analytical factors increases
Solution Approach 1:
The patent performs preliminary capture and concentration of biomarkers using affinity agents before the actual detection step. This preliminary action of pre-concentrating and pre-purifying the biomarkers in a single step reduces subsequent processing time and minimizes the impact of pre-analytical variables, enabling faster turnaround while maintaining consistency.
Solution Approach 2:
The patent merges multiple steps (capture, concentration, and detection) into an integrated process using affinity agents. By combining these functions into a unified approach rather than separate sequential steps, the method reduces turnaround time and minimizes variability introduced by multiple handling and processing stages.
3Loss of information
If disease-derived proteins are detected in urine, then valuable patient insights are provided, but the exceedingly low concentration of these proteins poses an analytical challenge
Solution Approach 1:
The patent utilizes porous affinity materials that provide high surface area for biomarker capture. The porous structure allows efficient interaction between the affinity agents and low-concentration biomarkers in urine, enabling detection and concentration of trace proteins that would be undetectable by conventional methods while preserving all biomarker information.
Solution Approach 2:
The patent employs composite affinity materials that combine multiple functional properties (high binding capacity, selectivity, and stability) in a single system. These composite materials enable the detection and concentration of extremely low-abundance biomarkers in urine by providing enhanced binding sites that maintain information integrity while overcoming the detection limit challenges.
4Stability of the object's composition
If high abundance resident proteins such as uromodulin and albumin are present in urine, then the urine matrix is maintained, but these proteins mask rare proteins and evade disease identification
Solution Approach 1:
The patent selectively extracts rare disease-related proteins from the urine matrix using specific affinity agents that bind only to target biomarkers. This selective extraction removes the rare proteins of interest from the background of high-abundance proteins like uromodulin and albumin, enabling their detection without interference while maintaining the overall understanding of the urine matrix composition.
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 method achieves high sensitivity (90%) and specificity (95%) in detecting target biomolecules, including those present at very low concentrations (2.5 picograms/mL or less), and allows for the detection of tick-borne pathogens like Borrelia, facilitating early and accurate diagnosis.
Implementation Method 1
contacting the filamentous material with a volume of a biological fluid to allow affinity agents to capture biomarkers present in the biological fluid
Data Source
AI summary
An embodiment of the invention relates to a method for diagnosing Lyme disease, comprising: isolating a diagnostic composition from a biological sample, wherein the biological sample is urine or another bodily fluid, the diagnostic composition comprising a biomarker attributable to Borrelia strains, bound or complexed to an affinity molecule that is bound or complexed to a filamentous material; and analyzing isolated diagnostic composition using a mass spectrometry, an immunoassay, a protein sequencing, or other analytical methods to detect presence of Borrelia-derived biomarkers.