Exosome RNA Biosensor for Asymptomatic SARS-CoV-2 Detection
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Solution Overview
Problem
Current methods for detecting infectious diseases, such as COVID-19, face limitations including high false-positive/false-negative rates, lengthy turnaround times, and the need for healthcare worker exposure, particularly with antigen/antibody tests, which are not effective for asymptomatic or pre-symptomatic cases.
Innovation Solution
A method and biosensor device that utilizes ribonucleic acid (RNA) molecules from exosomes to detect SARS-CoV-2 by isolating cell-type specific small extracellular vesicles and analyzing microRNAs, providing a multiparametric detection of viral RNA and host EV microRNAs, even when viral loads are below detectable limits, using bind-elute microfluidics and electrical probe-based detection, with results available within 3 hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If qPCR based COVID-19 testing from nasopharyngeal swabs is used, then detection accuracy is improved, but healthcare workers are exposed to possible infections and PPE supply is required
Solution Approach 1:
The patent uses an automated liquid handling system as an intermediary between the sample and the healthcare worker. The system performs all liquid manipulation steps (pipetting, mixing, incubation) automatically, eliminating the need for healthcare workers to handle infectious samples directly while maintaining qPCR detection accuracy
Solution Approach 2:
The patent replaces manual mechanical operations with an automated liquid handling system that uses robotic arms, automated pipettes, and computer-controlled mechanisms. This substitution eliminates human exposure to infectious materials while maintaining the same detection capabilities
2Loss of time
If antibody tests are used, then turnaround time is reduced, but specificity and sensitivity are compromised
Solution Approach 1:
The patent merges the speed advantage of antibody tests with the accuracy advantage of qPCR testing in a single automated platform. The system can perform both types of detection sequentially or in parallel, providing rapid results with high specificity and sensitivity by combining multiple detection modalities
Solution Approach 2:
The automated liquid handling system is designed to perform multiple functions: it can execute both antibody-based rapid tests and qPCR-based accurate tests using the same hardware platform. This multi-functionality allows the system to achieve both rapid turnaround and high diagnostic accuracy depending on the test protocol selected
3Measurement precision
If current diagnostic tests are used, then symptomatic cases can be detected, but asymptomatic and pre-symptomatic cases are missed
Solution Approach 1:
The patent enables preliminary detection of SARS-CoV-2 infection before symptoms appear by implementing automated testing protocols that can be performed on asymptomatic individuals. The system detects viral genetic material or antibodies in the blood, providing early warning of infection before clinical symptoms develop, thus allowing for pre-symptomatic identification
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 significantly reduces false-positive/negative results, allows for rapid and accurate detection of SARS-CoV-2, including asymptomatic cases, and enables point-of-care testing without exposing healthcare workers, providing insights into disease severity and aiding in treatment decisions.
Implementation Method 1
a separation module configured to separate ribonucleic acid (RNA) molecules from other components in a biological sample
Implementation Method 2
a biosensor module comprising a set of bioreceptors configured to bind a plurality of cell-specific exosomal RNA molecules
Implementation Method 3
electrical, probe-based detection
Data Source
AI summary
Provided herein are methods of detecting a disease, condition, or disorder in a subject. In some embodiments, the methods include obtaining a set of ribonucleic acid (RNA) molecules from a population of exosomes in a biological sample obtained from the subject and detecting a plurality of target RNA molecules corresponding to a selected set of cell-specific exosomal RNA molecules in the set of RNA molecules to generate a target RNA molecular profile for the sample. In some of these embodiments, the methods also include determining that the target RNA molecular profile substantially matches a reference RNA molecular profile that correlates with the disease, condition, or disorder in a subject and/or using at least one algorithm that predicts a likelihood that the target RNA molecular profile correlates with the disease, condition, or disorder in a subject. Related biosensor devices, kits, and systems are also provided.