Absorptive Matrix Drying for Extracellular Vesicle Biomarker Preservation
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Solution Overview
Problem
Conventional methods for sample collection, particularly for venous blood, face challenges such as accessibility issues for rural and elderly populations and anxiety related to venipuncture, leading to low compliance and disengagement from medical care, necessitating innovative solutions for improved access to diagnostic testing.
Innovation Solution
A device and method for collecting bodily fluid samples using an absorptive matrix that allows for at-home or field sampling, where the sample is dried and shipped to a laboratory for analysis, focusing on the preservation and detection of extracellular vesicles as disease biomarkers, enabling multiple sample collections and analysis using proximity ligation assays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional venous blood sampling methods are used, then diagnostic testing can be performed, but accessibility and compliance are reduced due to geographical barriers, anxiety, and inconvenience
Solution Approach 1:
The invention enables patients to perform self-service blood sampling at home using a finger-prick method with a collection device that includes a lancet, absorptive matrix, and sealing mechanism. This eliminates the need for patients to travel to clinical laboratories, directly addressing accessibility barriers and reducing anxiety associated with venipuncture while maintaining sample quality for reliable diagnostic testing.
2Measurement precision
If venous blood samples are collected at clinical laboratories, then diagnostic accuracy is maintained, but geographical and personal obstacles prevent access for many populations
Solution Approach 1:
The invention introduces a stable intermediary system consisting of an absorptive matrix that captures and preserves blood components, combined with a sealing mechanism that protects the sample during transport. This intermediary allows capillary blood samples collected at home to maintain diagnostic accuracy equivalent to venous samples while enabling access for rural, elderly, and other populations who cannot easily reach clinical laboratories.
3Measurement precision
If multiple samples are collected over time, then representative data for disease detection is improved, but sample management and tracking become more complex
Solution Approach 1:
The invention segments the sample collection process into individual, self-contained collection devices, each with its own unique identifier. Patients can collect multiple samples over time using identical simple devices, and the segmentation of samples into discrete, trackable units simplifies management and tracking while enabling longitudinal studies and improved disease detection accuracy through multiple time-point sampling.
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 minimizes geographical, personal, and financial obstacles by allowing samples to be collected and analyzed at home, with dried samples being sent via mail for laboratory analysis, providing effective detection of disease biomarkers and improving access to diagnostic testing, especially for cancer diagnosis and monitoring.
Implementation Method 1
The collection device comprises a matrix that receives the sample. The sample is dried onto the matrix within the device.
Implementation Method 2
The matrix may be pre-treated with a sugar, an excipient, a surfactant, an antimicrobial agent, an antifungal agent, a proteinase inhibitor, a DNase inhibitor, an anticoagulant, and/or a desiccant.
Implementation Method 3
a bodily fluid is spotted onto an absorptive matrix and dried, after which the matrix (or device housing the matrix) is shipped to a laboratory for analysis
Data Source
AI summary
The invention provides methods and kits for the analysis of extracellular vesicle-derived biomarkers obtained from dried body fluid samples; including but not limited to blood spots extracted onto or into absorptive surfaces for analysis of extracellular vesicles for disease diagnosis, staging, monitoring and selection and efficacy of therapeutics.