Electrochemical test device

Inventors

Cardosi, Marco • Kirkwood, Stephanie • Baskeyfield, Damian

Assignees

GlucoRx Technologies Ltd

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Publication Number

US-10371617-B2

Patent

Publication Date

2019-08-06

Expiration Date


Abstract

An electrochemical test device for determining a concentration of one or more analytes in a fluid sample is provided. The electrochemical test device comprises a set of electrodes including two or more working electrodes, each working electrode for determining the concentration of a corresponding analyte, and sensing chemistry for each working electrode, wherein the sensing chemistry for a first of the two or more working electrodes comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase, wherein at least some of the diaphorase for the first working electrode is disposed in a diaphorase-containing layer which extends over the first working electrode and at least a second of the two or more working electrodes.

Core Innovation

The invention relates to an electrochemical test device for determining a concentration of one or more analytes in a fluid sample. The device comprises a set of electrodes including two or more working electrodes, where each working electrode determines the concentration of a corresponding analyte, and sensing chemistry for each working electrode.

The sensing chemistry for a first working electrode comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase, and a cofactor for the NAD(P)+-dependent dehydrogenase. At least some of the diaphorase for the first working electrode is disposed in a diaphorase-containing layer that extends over the first working electrode and at least a second of the two or more working electrodes, as a continuous or discontinuous layer.

Additional electrode-specific layers localize the corresponding analyte reactions at each working electrode. The disclosed sensing chemistry is based on an NAD(P)+-dependent pathway, with examples including glycerol with glycerol dehydrogenase, β-hydroxybutyrate with β-hydroxybutyrate dehydrogenase, lactate with lactate oxidase, and glucose with glucose oxidase.

Claims Coverage

The document includes two independent claims: one for the electrochemical test device and one for a manufacturing method. The independent claims describe at least two working electrodes with analyte-specific sensing chemistry, coordinated by a diaphorase-containing layer that extends across multiple working electrodes.

Diaphorase-containing layer spanning multiple working electrodes

An electrochemical test device comprising a set of electrodes including two or more working electrodes, each working electrode for determining the concentration of a corresponding analyte, with sensing chemistry for each working electrode, wherein the sensing chemistry for a first working electrode comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase, and wherein at least some of the diaphorase for the first working electrode is disposed in a diaphorase-containing layer which extends over the first working electrode and at least a second of the two or more working electrodes.

Depositing diaphorase in a diaphorase-containing layer over multiple working electrodes

A method of manufacturing an electrochemical test device comprising a set of electrodes including two or more working electrodes, each working electrode for determining the concentration of a corresponding analyte, and sensing chemistry for each working electrode, wherein the sensing chemistry for a first working electrode comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase, and comprising depositing diaphorase in a diaphorase-containing layer over the first working electrode and at least a second of the two or more working electrodes.

Across the independent claims, the inventive concept is a coordinated NAD(P)+-dependent sensing scheme at a first working electrode using diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase, and a cofactor, with diaphorase placed in a diaphorase-containing layer that extends over multiple working electrodes, and a manufacturing method that deposits that layer over the relevant electrodes.

Stated Advantages

Simplified manufacturing, enabled by sharing a diaphorase-containing layer while localizing analyte-specific reactions with additional electrode-specific layers.

Improved sensitivity/performance, enabled by layer separation and microenvironment tailoring.

Documented Applications

Electrochemical testing of analyte concentrations in a fluid sample using a test device/test strip with multiple working electrodes, including glycerol, β-hydroxybutyrate, lactate, and glucose targets.

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