Diagnosis of tuberculosis and other diseases using exhaled breath
Inventors
Chen, Dapeng • Bryden, Wayne A. • McLoughlin, Michael
Assignees
Publication Number
US-12019056-B2
Publication Date
2024-06-25
Expiration Date
2040-08-26
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Abstract
Disclosed are methods and devices for analyzing aerosol particles in exhaled breath using diagnostic tools that enable rapid, low cost and autonomous point of care assays for several diseases including respiratory tract diseases. Disclosed are methods and devices for capturing exhaled breath aerosols in a packed bed column and analyzing exhaled captured breath aerosols for tuberculosis diagnosis.
Core Innovation
The invention provides systems and methods for diagnosing respiratory diseases, including tuberculosis, by analyzing aerosol particles present in exhaled breath. The core system includes a sample extraction component shaped to interface with an individual's face to collect exhaled breath aerosols during specified breathing maneuvers, a sample capture component to collect these aerosols into a liquid, a packed bed column to selectively capture the particles from the liquid sample, means to elute the particles using solvents, and a diagnostic device to analyze the eluted particles for disease markers.
This approach addresses significant limitations of conventional diagnostic methods such as sputum, blood, or urine analysis, which can be invasive, slow, expensive, and difficult to implement for large-scale or point-of-care applications, particularly in active case finding of diseases like TB. Exhaled breath sampling is noninvasive, enables safer and more uniform sample collection, and captures biomarkers revealing infection from the respiratory tract.
The disclosed systems enhance diagnostic accuracy and utility by employing high-flow, chilled collection techniques, efficient aerosol concentration, and sensitive analysis tools—most notably mass spectrometry, including MALDI-MS. The packed bed column allows rapid extraction of key biomarkers, including lipids and metabolites related to respiratory diseases, from small sample volumes, supporting autonomous and real-time diagnostic functionality suitable for low-cost, portable, and high-throughput disease screening.
Claims Coverage
The patent claims cover two main independent inventive features: (1) a system for diagnosing respiratory diseases using exhaled breath and (2) a method for diagnosing respiratory diseases using exhaled breath.
System for diagnosing respiratory diseases using exhaled breath
A system comprising: - A sample extraction component configured to receive an individual's face for extracting breath aerosol (EBA) particles expelled during predetermined breath maneuvers into a flow of air. - A sample capture component fluidly connected to the extraction component, collecting the EBA particles as a liquid sample. - A packed bed column disposed downstream of the sample capture component, configured to selectively capture EBA particles from the liquid sample onto the packed bed. - Means to elute the collected EBA particles from the packed bed using one or more solvents. - A diagnostic device for analyzing the EBA particles comprised in the elution solvents.
Method for diagnosing respiratory diseases using exhaled breath
A method comprising: 1. Extracting EBA particles expelled into a flow of air fed into a sample extraction component configured to receive an individual's face. 2. Collecting the EBA particles from exhaled breath and air as a liquid sample using a sample capture component. 3. Capturing the EBA particles in the collected liquid sample using a packed bed column disposed downstream to selectively capture the particles onto the packed bed. 4. Eluting the collected EBA particles from the packed bed using one or more solvents. 5. Analyzing the EBA particles comprised in the one or more solvents.
In summary, the claims protect a comprehensive system and method for extracting, capturing, eluting, and diagnosing respiratory disease markers from exhaled breath aerosols by means of a packed bed column and downstream analytical protocols.
Stated Advantages
Enables rapid, low-cost, and autonomous point of care assays for diagnosing respiratory diseases, including tuberculosis.
Provides a noninvasive, safer, and more uniform sample collection compared to sputum or blood-based approaches.
Reduces diagnostic time, supporting near real-time analysis suitable for active case finding and point-of-care use.
Minimizes the need for expensive consumables and enables analysis from small sample volumes.
Capable of high sensitivity and specificity in detecting disease-related biomarkers in exhaled breath.
Documented Applications
Diagnosis of tuberculosis using exhaled breath aerosols containing disease biomarkers.
Diagnosis of other respiratory tract diseases by identifying microbes, viruses, or biomarkers in exhaled breath.
Active case finding (ACF) for tuberculosis and other respiratory diseases outside primary healthcare systems.
Differentiating between infected and healthy individuals through analysis of volatile organic compounds or nonvolatile biomarkers captured from exhaled breath.
Autonomous point-of-care testing for multiple diseases with rapid results.
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