Methods of obtaining and using electrochemical diagnostic results
Inventors
KARUMANCHI, Devi Kalyan • Kelly, Michelle • Meadow, William D.
Assignees
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Publication Number
US-11513097-B1
Publication Date
2022-11-29
Expiration Date
Abstract
Methods and techniques are described for analyzing test fluids to determine presence, absence, or concentration of analytes in the test fluids. The methods may correspond to diagnostic testing, such as quickly (within 5 minutes) identifying whether or not an individual may have a particular disease or condition, such as infection by SARS-CoV-2 or a SARS-CoV-2 variant or vaccine-induced immunity or natural immunity to infection by SARS-CoV-2 or a SARS-CoV-2 variant, or whether an individual would benefit from a vaccine booster. The test results can be used for a variety of applications including facilitating or controlling access at events, venues, or transportation systems, or generating exposure notifications.
Core Innovation
The invention provides an electrochemical test strip device and a method for detecting a target analyte in a test fluid using differential electrochemical measurement. The test strip device includes a first set of electrodes with a first working electrode functionalized with active capture molecules that include a plurality of electroactive redox tags and are configured to bind the target analyte, and a second set of electrodes with a second working electrode functionalized with null capture molecules that include a plurality of electroactive redox tags and are configured to bind different analytes than the active capture molecules or to be configured not to bind the target analyte.
The first working electrode and the second working electrode each include a heterogeneous self-assembled-monolayer (SAM) having a linker component and a charged passivation component. The charged passivation component is bound to the surface of each working electrode, and the linker component terminally binds the active capture molecules or null capture molecules on one end while binding the surface of the working electrode on the other end. The linker component and the capture molecules comprise a click chemistry adduct or bioconjugate, forming the electrochemical interface for binding and electroactive signaling.
The invention further adds anti-fouling capability to both heterogeneous SAMs by including an anti-fouling formulation comprising a plurality of different charged glycosaminoglycans bound to the surfaces and interspersed between the linker component and the charged passivation component. The method receives the test fluid, couples the electrochemical test strip device to an interface device, and obtains voltammograms using one or more potentiostats of the interface device.
The voltammograms are analyzed to identify a test result indicating a presence, absence, or quantitative measure of the target analyte, and the test result outputs in less than 5 minutes of receiving the test fluid at the fluid chamber or coupling the device to the interface device.
Claims Coverage
The provided content identifies one independent claim and several dependent claims. The main claim includes differential electrode functionalization, heterogeneous click-chemistry SAMs with anti-fouling charged glycosaminoglycans, and analysis of voltammograms to output presence/absence or quantitative results within a defined time.
Differential active and null capture electrode sets with electroactive redox tags
An electrochemical test strip device having a first set of electrodes functionalized with active capture molecules including a plurality of electroactive redox tags configured to bind the target analyte and a second set of electrodes functionalized with null capture molecules including a plurality of electroactive redox tags configured to bind different analytes than the active capture molecules or configured not to bind the target analyte, wherein the first and second electrode sets are configured to provide a differential measurement to identify the target analyte.
Heterogeneous SAM with click chemistry adducts or bioconjugates and charged passivation
A first working electrode functionalized with a first heterogeneous self-assembled-monolayer (SAM) including a first linker component and a charged passivation component, wherein the charged passivation component is bound to the surface and the first linker component terminally binds the active capture molecules and binds the surface, with the first linker component and active capture molecule comprising a click chemistry adduct or bioconjugate; and a second working electrode functionalized with a second heterogeneous SAM with a second linker component and the charged passivation component, wherein the second linker component terminally binds the null capture molecules and the second linker component and null capture molecule comprise a click chemistry adduct or bioconjugate.
Anti-fouling charged glycosaminoglycans interspersed in heterogeneous SAMs
Each heterogeneous SAM further comprises an anti-fouling formulation comprising a plurality of different charged glycosaminoglycans bound to the surfaces of the first working electrode and the second working electrode and interspersed between the linker component and the charged passivation component.
Interface-device voltammetry with differential analysis and fast output
A method that receives the test fluid in a fluid chamber, couples the electrochemical test strip device to an interface device, obtains voltammograms using one or more potentiostats of the interface device, analyzes the voltammograms to identify a test result indicating a presence, absence, or quantitative measure of the target analyte, and outputs the test result in less than 5 minutes of receiving the test fluid or coupling the device.
Machine-learning transformation of voltammograms for test result determination
Analyzing the voltammograms by inputting them into a trained machine-learning model that uses learned parameters and transformation functions to produce a test result indicating the presence, absence, or quantity of a target analyte.
SARS-CoV-2 variant infection-linked test result
Configuring the method such that a test result indicates infection by a SARS-CoV-2 variant.
SARS-CoV-2 variant and specific viral structural protein targets
Further limited such that the viral infection-developed antibody and the antiviral vaccine-developed antibody, or the viral structural protein, specifically involve SARS-CoV-2 or SARS-CoV-2 variant antibodies and/or SARS-CoV-2 spike, nucleocapsid, and/or envelope proteins.
Compliance marker detection in scheduled pharmaceutical timing
Detecting a target analyte that is a compliance marker or its metabolite provided in a pharmaceutical formulation, where a test fluid is collected at a predetermined time after scheduled administration to an individual.
Adherence/compliance determination and time-stamped notification or report
Analyzing a test result to determine whether it complies with or indicates adherence to a treatment regimen, and generating a time-stamped notification or report with the test result and the determined compliance or adherence status.
Overall claim coverage centers on differential voltammetric detection using paired active and null capture electrode sets with electroactive redox tags, heterogeneous SAM functionalization using click chemistry adducts or bioconjugates, and anti-fouling charged glycosaminoglycan formulations. Dependent refinements specify SARS-CoV-2 or SARS-CoV-2 variant-oriented targets and interpretation using a trained machine-learning model, and further include compliance and adherence contexts including pharmaceutical timing and time-stamped reporting.
Stated Advantages
Outputs a test result in less than 5 minutes of receiving the test fluid at the fluid chamber or coupling the electrochemical test strip device to the interface device.
Differential measurement enables identification of the target analyte from one or more test analytes.
Anti-fouling formulation includes anti-fouling charged glycosaminoglycans interspersed in heterogeneous SAMs.
Documented Applications
Detection of SARS-CoV-2 infection-developed antibody and/or vaccine-developed antibody and/or viral structural proteins for SARS-CoV-2 or SARS-CoV-2 variants, including identification of a test result indicating infection by a SARS-CoV-2 variant.
Detection of a target analyte that is a compliance marker or its metabolite provided in a pharmaceutical formulation, using test fluid collected at a predetermined time after scheduled administration to an individual.
Adherence monitoring by determining whether a test result complies with or indicates adherence to a treatment regimen, including generating a time-stamped notification or report with the test result and compliance or adherence status.
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