Electrochemical diagnostic system

Inventors

KARUMANCHI, Devi Kalyan • Shourideh, Seyedeh • Hendrix, Charles • Rose, Marc • Meadow, William D.

Assignees

Persown Inc

Abstract

Described are devices, systems, kits, methods, and techniques for analyzing test fluids to determine presence, absence, or concentration of analytes in the test fluids and useful for performing diagnostic testing, such as to quickly identify 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. The devices, systems, kits, methods, and techniques described herein can be used to detect analytes in body fluids using a functionalized electrochemical test strip and potentiostatic measurements, allowing for prompt identification of whether or not an individual has a particular disease or condition, such as in a period of 5 minutes or less.

Core Innovation

The invention provides an electrochemical test strip device that performs differential measurement to identify a target analyte from one or more test analytes in a test fluid. The device uses a first set of electrodes that includes a first working electrode functionalized with active capture molecules directly labeled with a plurality of electroactive redox tags and configured to bind a target analyte, and a second set of electrodes including a second working electrode functionalized with null capture molecules directly labeled with a plurality of electroactive redox tags and configured not to bind the target analyte.

The device includes a fluid chamber in fluid communication with the first set of electrodes and the second set of electrodes to establish contact between the test fluid and each working electrode. The first set of electrodes and the second set of electrodes are configured to provide a differential measurement for identifying the target analyte from the one or more test analytes.

Each working electrode includes a heterogeneous self-assembled-monolayer (SAM) with a linker component and a charged passivation component. The linker component terminally binds the capture molecules on one end and binds the electrode surface on the other end, and the linker component and capture molecule comprise a click chemistry adduct or bioconjugate.

The heterogeneous SAM on each working electrode further comprises an anti-fouling formulation comprising a plurality of different charged glycosaminoglycans bound to the electrode surfaces and interspersed between the linker component and the charged passivation component.

Claims Coverage

The patent text provided includes one independent claim. The claim coverage emphasizes differential electrode measurement using actively binding versus non-binding capture molecules, both directly labeled with electroactive redox tags, together with heterogeneous SAM architectures with click chemistry and charged glycosaminoglycans for anti-fouling.

The core claim structure combines a dual-electrode differential measurement architecture with heterogeneous SAM electrode functionalization that uses click chemistry adducts or bioconjugates and an anti-fouling formulation comprising different charged glycosaminoglycans interspersed between linker and charged passivation components.

Stated Advantages

Documented Applications