Low cost test strip and method to measure analyte
Inventors
Morgan, Thomas T. • NOLAN, Bryan • Carnahan, David L.
Assignees
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Publication Number
US-11747324-B2
Publication Date
2023-09-05
Expiration Date
Abstract
Materials and manufacturing techniques to produce test strips in high volume at low-cost for the measurement of gas in various industries and environments are disclosed. The test strip is generally comprised of a substrate, at least one electrical connection, at least one sensing chemistry and at least one additional layer. The test strip may provide a quantitative author a qualitative read out. A method for collecting and analyzing data to monitor and manage patients with chronic respiratory disease is disclosed. Implementations include software applications, connected medical devices, web servers and electronic catalogs. A method for identifying treatment trends from a population combining medical, biological and environmental data is disclosed. A method for proactively alerting and patients, caregivers and medical providers to trends in health by using the implementations of the invention are disclosed.
Core Innovation
A low-cost, high-volume gas/analyte test strip system includes a flexible substrate layer, a first electrode pair disposed upon the flexible substrate layer, and at least one sensing chemistry selected based on an analyte of interest. The sensing chemistry comprises functionalized nanostructures that bind to an analyte, causing at least one of an electrical resistance change across the nanostructures and a redox reaction at the nanostructures, providing sensing based on electrical resistance/current/voltage changes and optionally electrochemical behavior.
The test strip further includes at least one flexible spacing layer disposed upon at least a portion of the flexible substrate layer and upon at least a portion of the first electrode pair, with the flexible spacing layer not in contact with at least a portion of the sensing chemistry. A flexible protective layer is disposed above the flexible spacing layer and is not in contact with at least a portion of the sensing chemistry, where the flexible protective layer is impermeable to at least the analyte of interest.
At least a portion of the flexible substrate layer, at least a portion of the flexible spacing layer, and at least a portion of the flexible protective layer define a chamber enclosing at least a portion of the functionalized nanostructures. The described system addresses monitoring chronic respiratory diseases using gas/analyte testing and provides quantitative, semi-quantitative, or qualitative outputs based on electrical sensing associated with functionalized nanostructures.
Claims Coverage
Two independent claims are identified. The claim coverage includes the structural combination of the flexible nanostructure-functionalized sensing chemistry, chamber-forming layers, and electrodes for electrical resistance and/or redox-based sensing, and a corresponding method measuring electrical resistance change and/or redox response via an electrode pair to determine analyte concentration.
Functionalized nanostructure sensing chemistry in a chamber-forming layered flexible test strip
A test strip comprising a flexible substrate layer, a first electrode pair disposed upon the flexible substrate layer, at least one sensing chemistry selected based on an analyte of interest and disposed upon at least a portion of the substrate layer and at least a portion of the first electrode pair, wherein the sensing chemistry comprises functionalized nanostructures to bind to an analyte causing at least one of an electrical resistance change across the nanostructures and a redox reaction at the nanostructures, and wherein a flexible spacing layer and a flexible protective layer define a chamber enclosing at least a portion of the functionalized nanostructures.
Measuring electrical resistance change and/or redox via an electrode pair to determine analyte concentration
A method for determining a concentration of at least one analyte in a fluid sample by providing a test strip having a flexible substrate layer, a first electrode pair disposed upon the flexible substrate layer, at least one sensing chemistry selected based on an analyte of interest and comprising functionalized nanostructures that cause at least one of an electrical resistance change across the nanostructures and a redox reaction at the nanostructures, and measuring at least one of an electrical resistance change across the nanostructures and a redox reaction at the nanostructures via the first electrode pair.
The claim coverage centers on functionalized nanostructures arranged on electrode pairs to produce electrical resistance change and/or a redox reaction, with flexible spacing and protective layers forming a chamber that encloses the functionalized nanostructures while controlling contact. The method claim directly measures the electrical resistance change and/or redox response via the electrode pair to determine analyte concentration in a fluid sample.
Stated Advantages
Low-cost, high-volume test strip system.
Provides quantitative, semi-quantitative, or qualitative outputs based on electrical sensing associated with functionalized nanostructures.
Addresses monitoring chronic respiratory diseases using gas/analyte testing.
Documented Applications
Monitoring chronic respiratory diseases using gas/analyte testing based on biomarkers in exhaled breath, including exhaled nitric oxide (NO).
Combining patient biomarkers with clinical/environmental data for analytics, trend detection, and proactive alerts.
Integration of a gas delivery/conditioning device and sample flow constraints to control a breath-flow rate/volume relationship for the sensing chamber, with optional filtering/diversion of breath for sensing.
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