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-11435340-B2
Publication Date
2022-09-06
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 and/or 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 flexible test strip is provided with a flexible substrate layer and a first electrode pair disposed upon the flexible substrate layer, where the first electrode pair is configured to measure a chemical reaction. At least one sensing chemistry is selected based on an analyte of interest and is disposed upon at least a portion of the flexible substrate layer and upon at least a portion of the first electrode pair. The sensing chemistry comprises functionalized nanostructures configured to bind to an analyte, causing at least one of an electrical resistance change across the nanostructures and a redox reaction at the nanostructures.
At least one flexible spacing layer is disposed upon at least a portion of the flexible substrate layer and upon at least a portion of the first electrode pair, covers at least a portion of the flexible substrate layer and covers at least a portion of the first electrode pair, and is not in contact with at least a portion of the sensing chemistry. A flexible protective layer is disposed upon the flexible spacing layer, is not in contact with at least a portion of the sensing chemistry, and is permeable to at least the analyte of interest.
At least a portion of the flexible substrate layer, at least a portion of the at least one 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. A method is also provided for determining a concentration of at least one analyte in a fluid sample by providing the test strip and measuring at least one of the electrical resistance change across the nanostructures and the redox reaction at the nanostructures via the first electrode pair.
Claims Coverage
The independent claims identified are clm-00001 and clm-00010. The claim set covers three inventive features.
Chambered flexible strip with functionalized nanostructure sensing
A test strip comprising a flexible substrate layer, a first electrode pair disposed upon the flexible substrate layer and configured to measure a chemical reaction, and at least one sensing chemistry selected based on an analyte of interest and comprising 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, wherein 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.
Non-contact layered isolation with analyte-permeable protection
At least one flexible spacing layer is disposed on the flexible substrate layer and on at least a portion of the first electrode pair, covers at least a portion of the flexible substrate layer and covers at least a portion of the first electrode pair, and is not in contact with at least a portion of the sensing chemistry, and a flexible protective layer is disposed upon the flexible spacing layer, is not in contact with at least a portion of the sensing chemistry, and is permeable to at least the analyte of interest.
Determining analyte concentration by electrical measurement through functionalized nanostructures
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 and configured to measure a chemical reaction, sensing chemistry comprising functionalized nanostructures to bind to an analyte and causing at least one of an electrical resistance change across the nanostructures and a redox reaction at the nanostructures, forming a chamber enclosing at least a portion of the functionalized nanostructures, and measuring at least one of the electrical resistance change across the nanostructures and the redox reaction at the nanostructures via the first electrode pair.
Overall, the independent claims focus on a flexible layered test strip with a chambered region for functionalized nanostructures that bind an analyte and produce measurable electrical effects, and on determining analyte concentration by measuring those electrical effects via the electrode pair.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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