ELECTROCHEMICAL TEST SENSOR
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Accused Products
Abstract
Disclosed is an electrochemical sensor for the determination of analytes in body fluids, e.g. glucose in blood. The sensor involves a non-conductive base which provides a flow path for the body fluid with the base having a working and counter electrode on its surface which are in electrical communication with a detector of current. The base and a cover therefore provide a capillary space containing the electrodes into which the body fluid is drawn by capillary action. The counter electrode has a sub-element which contains an electroactive material and is configured in the system (sensor and meter) to provide an error signal when insufficient body fluid is drawn into the capillary.
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Citations
40 Claims
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1-10. -10. (canceled)
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11. An electrochemical test sensor for detecting the concentration of an analyte in a fluid test sample, the test sensor comprising:
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a non-conductive base that provides a flow path for the fluid test sample, the base including a counter electrode, a working electrode and a sub-element on an upper surface thereof, the counter and working electrodes being adapted to be in electrical communication with a detector of electrical current, the sub-element being physically disconnected from the counter electrode, the sub-element comprising an electroactive material that is adapted to allow oxidation to occur at the surface of the working electrode under an applied potential;
a reaction layer on at least the surface of the working electrode, the reaction layer comprising an enzyme; and
a cover coupled with the non-conductive base and forming a capillary space with an opening for the introduction of the fluid test sample thereto, the space forming a flow path for the fluid test sample, wherein the sub-element of the counter electrode is located upstream from the working electrode relative to the opening such that when electrochemical communication occurs between only the sub-element and the working electrode there is insufficient flow of electrical current through a detector to constitute a valid determination of the analyte concentration in the fluid test sample. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. An electrochemical test sensor adapted to assist in determining the concentration of an analyte in a fluid test sample, the test sensor comprising:
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a base assisting in forming an opening for introducing the fluid test sample;
a working electrode being coupled to the base;
a counter electrode being coupled to the base, the counter electrode and the working electrode being adapted to be in electrical communication with a detector of electrical current, a portion of the counter electrode being located downstream relative to the opening and at least a portion of the working electrode; and
a sub-element being coupled to the base, the sub-element being physically disconnected from the counter electrode, the sub-element comprising an electroactive material that is adapted to allow oxidation to occur at the surface of the working electrode under an applied potential, the sub-element of the counter electrode being located upstream from the working electrode relative to the opening such that when electrochemical communication occurs between only the sub-element and the working electrode there is insufficient flow of electrical current through a detector to constitute a valid determination of the analyte concentration in the fluid test sample. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32)
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33. A method of determining whether a sufficient quantity of a fluid test sample has been introduced to an electrochemical test sensor, the method comprising the acts of:
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providing the electrochemical test sensor adapted to assist in determining the concentration of an analyte in a fluid test sample, the sensor comprising a base, a working electrode, a counter electrode and a sub-element, the base assisting in forming an opening for introducing the fluid test sample, the working electrode being coupled to the base, the counter electrode being coupled to the base, the counter electrode and the working electrode being adapted to be in electrical communication with a detector of electrical current, at least a portion of the counter electrode being located downstream relative to the opening and at least a portion of the working electrode, the sub-element being coupled to the base, the sub-element being physically disconnected from the counter electrode, the sub-element comprising an electroactive material that is adapted to allow oxidation to occur at the surface of the working electrode under an applied potential, the sub-element of the counter electrode being located upstream from the working electrode relative to the opening such that when electrochemical communication occurs between only the sub-element and the working electrode there is insufficient flow of electrical current through a detector to constitute a valid determination of the analyte concentration in the fluid test sample;
introducing the fluid test sample to the test sensor; and
determining whether a sufficient quantity of the fluid test sample has been introduced and, if not, notifying a user that an insufficient quantity of the fluid test sample has been introduced. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40)
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Specification