Rapid response glucose sensor
First Claim
1. A disposable electrochemical sensor for the detection of an analyte in a liquid sample comprising a working electrode and a reference electrode disposed within a sample-receiving cavity, a reagent layer disposed within the sample-receiving cavity and over at least the working electrode, said reagent layer comprising an enzyme for producing an electrochemical signal in the presence of the analyte, wherein the sample-receiving cavity has a volume of less than 1.5 μ
- l and wherein the sensor provides a stable reading of the amount of analyte in a period of 10 seconds or less.
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Accused Products
Abstract
A disposable electrochemical sensor for the detection of an analyte such as glucose in a liquid sample is provided. The sensor has a working electrode and a reference electrode disposed within a sample-receiving cavity, and a reagent layer disposed within the sample-receiving cavity and over the working electrode. The reagent layer contains at least an enzyme for producing an electrochemical signal in the presence of the analyte. The sample-receiving cavity has a volume of less than 1.5 μl, and the sensor provides a stable reading of the amount of analyte in a period of 10 seconds or less. Where appropriate for the generation of electrochemical signal, for example in the case of glucose detection, the reagent layer also contains a mediator. The sensor is used in combination with a meter for detection of the analyte in a liquid sample. A suitable meter has a timing circuit for controlling the measurement of current indicative of analyte in the sample following detection of sample application to a test strip inserted in the meter, wherein the timing circuit causes the measurement of current to occur at a time 10 seconds or less after the detection of sample application.
270 Citations
19 Claims
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1. A disposable electrochemical sensor for the detection of an analyte in a liquid sample comprising a working electrode and a reference electrode disposed within a sample-receiving cavity, a reagent layer disposed within the sample-receiving cavity and over at least the working electrode, said reagent layer comprising an enzyme for producing an electrochemical signal in the presence of the analyte, wherein the sample-receiving cavity has a volume of less than 1.5 μ
- l and wherein the sensor provides a stable reading of the amount of analyte in a period of 10 seconds or less.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 18, 19)
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12. A meter for use in combination with a disposable electrochemical sensor for detection and/or quantification of an analyte in a liquid sample comprising a timing circuit for controlling the measurement of current indicative of analyte in the sample following detection of sample application to a test strip inserted in the meter, wherein the timing circuit causes the measurement of current to occur at a time 15 seconds or less after the detection of sample application.
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16. A system for electrochemical detection of an analyte in a liquid sample, comprising:
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(a) a disposable electrochemical sensor comprising a working electrode and a reference electrode disposed within a sample-receiving cavity, a reagent layer disposed within the sample-receiving cavity and over the working electrode, said reagent layer comprising an enzyme for producing an electrochemical signal in the presence of the analyte, wherein sample-receiving cavity has a volume of less than 1.5 μ
l and wherein the sensor provides a stable reading of the amount of analyte in a period of 10 seconds or less; and
(b) a test meter for receiving the disposable electrochemical sensor, said meter comprising a timing circuit for controlling the measurement of current indicative of analyte in the sample following detection of sample application to a test strip inserted in the meter, wherein the timing circuit causes the measurement of current to occur at a time 15 seconds or less after the detection of sample application.
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17. A method for making a disposable electrochemical sensor for the detection of an analyte, comprising the steps of:
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(a) forming a working and a reference electrode on a substrate;
(b) forming a reagent layer over at least the working electrode, said reagent layer comprising at least an enzyme for producing an electrochemical signal in the presence of the analyte in a rapidly hydrating matrix;
(c) forming an insulating layer over the reagent layer, said insulating layer having an opening formed therein through which at least a portion of the reagent layer is exposed;
(d) forming three adhesive pads on the substrate, a first adhesive pad being disposed at a first side of the reagent layer, a second adhesive pad being disposed at a second side of the reagent layer opposite from the first adhesive pad, whereby the reagent layer and the underlying electrodes are disposed between the first and second adhesive pads, and a third adhesive pad being disposed on a third side of the reagent layer different from the first and second sides and separated from the reagent layer;
(e) laminating a first hydrophilic film over the first and second adhesive pads, said first hydrophilic film spanning the space between the first and second adhesive pads, and a second hydrophilic film over the third adhesive pad;
(f) adhering a top cover over the hydrophilic films, whereby a sample chamber is formed which is defined by the substrate, the first and second adhesive pads and the first hydrophilic film.
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Specification