Noninvasive point of care biomarker detection from breath samples
Inventors
Lynn, Michael Scott • Heanue, Joseph A. • Anekal, Samartha G. • LIMTAO, Kevin M. • Dunk, Kevin Bradford • Schuster, Jeffrey A. • Stoll, Jeffrey A.
Assignees
Triple Ring Technologies Inc • Hound Labs Inc
Publication Number
US-11821821-B1
Publication Date
2023-11-21
Expiration Date
2040-01-29
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Abstract
Methods, systems and techniques for the accurate measurement of breath-borne biomarkers are disclosed. Such methods, systems and techniques may be used for the purposes of detection and/or measurement in breath samples of biomarkers, e.g., biomarkers relating to a disease or a physiological condition.
Core Innovation
The invention provides methods, systems, and devices for noninvasive, point-of-care detection of biomarkers from breath samples, specifically enabling the accurate measurement of breath-borne biomarkers such as acetone associated with physiological conditions like diabetes. It utilizes at least one impactor that captures aerosol droplets from an exhaled breath sample via impaction, concentrating analytes into a microfluidic plate that incorporates reaction channels with acetone-specific reagents immobilized on them.
The device detects the amount of an indicator biomarker, such as acetone, from the captured aerosol droplets using various assay techniques including immunoassays, chemiluminescence, enzymatic, or electrochemical detection. One or more processors analyze the captured sample and determine the existence of a physiological condition in the subject by comparing the detected biomarker amount to a threshold value, or by comparing it to a reference biomarker known to exist at a stable concentration in the subject.
The problem addressed is the need for portable, sensitive, and accurate systems that enable rapid, noninvasive biomarker quantification from minute quantities present in breath, overcoming the challenges of diluteness and specificity while supporting point-of-care testing. The approach leverages sample concentration using impactors, microfluidic analysis, and tailored channel chemistry to provide robust detection and interpretation relevant to clinical diagnosis, such as diabetes determination.
Claims Coverage
There are three independent claims, each describing inventive features for point-of-care biomarker detection from exhaled breath using impactors, microfluidics, and specific biomarker analysis.
Point-of-care device with impactor-based aerosol droplet capture and microfluidic acetone detection
A device comprising: - At least one impactor configured to capture aerosol droplets contained in an exhaled breath sample via impaction. - A microfluidic plate fluidly coupled to the impactor, having at least one reaction channel with acetone-specific reagent immobilized thereon. - One or more processors operable to detect an amount of an indicator biomarker (acetone) from the captured aerosol droplets and determine, based on the amount exceeding a threshold concentration, the existence of a physiological condition in the subject.
Point-of-care device measuring indicator and reference biomarkers from breath for condition determination
A device comprising: - At least one impactor capturing aerosol droplets from exhaled breath via impaction. - A microfluidic plate with at least one reaction channel having acetone-specific reagent immobilized. - Processors operable to: (1) measure the amount of an indicator biomarker (acetone) in captured aerosol droplets; (2) measure an amount of a reference biomarker in the sample; and (3) determine the existence of a physiological condition based on whether the indicator biomarker exceeds the reference biomarker.
Point-of-care method for detecting physiological condition via breath-based acetone quantification using impactor and microfluidics
A method comprising: - Separating a plurality of aerosol droplets from a captured breath sample using at least one impactor. - Detecting, with a microfluidic plate incorporating a reaction channel with acetone-specific reagent, an amount of acetone present in the separated droplets. - Determining, based on the amount of acetone detected, the presence of a physiological condition in the human.
The claims cover portable point-of-care devices and methods that noninvasively capture breath aerosol droplets with an impactor, analyze indicator (and optionally reference) biomarkers using microfluidic channels with immobilized reagents, and determine physiological conditions such as diabetes based on the detected analyte levels.
Stated Advantages
The device and methods enable noninvasive, point-of-care detection and quantification of biomarkers from breath, providing rapid, convenient, and portable analysis.
Sample capture by impaction yields high efficiency for collecting breath-borne biomarkers, especially in aerosolized droplets, leading to highly sensitive detection even at very low analyte concentrations.
The system supports enhanced sensitivity and device scalability, overcoming low prevalence of target analytes in breath and allowing reliable measurement suitable for clinical and evidentiary standards.
Utilization of microfluidic plates with immobilized specific reagents supports adaptability to detect a range of biomarkers and physiological conditions from the same platform.
Reference biomarker normalization allows for improved quantification accuracy in variable breath samples, increasing the reliability of the diagnostic result.
Documented Applications
Detection of the presence or existence of diabetes in a human subject by measuring acetone levels in breath aerosol droplets at the point of care.
Point-of-care determination of physiological conditions in subjects using noninvasive breath sample collection and analysis.
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