Small volume in vitro analyte sensor and methods of making
First Claim
1. A sensor for determining a concentration of an analyte in a sample, the sensor comprising:
- a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a sensor comprising a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, a first side edge and a second side edge extending from the proximal end to the distal end of the sensor, and the proximal end of the sensor comprising first and second extensions;
a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending with a substantially uniform width from the first aperture to the second aperture;
a working electrode disposed on the first substrate;
an analyte-responsive enzyme disposed on the working electrode;
a counter electrode disposed on the second substrate, wherein the working electrode and the counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber;
an indicator electrode disposed on at least one of the first and second substrates and positioned relative to a sample flow path within the sample chamber to indicate that, when sample contacts the indicator electrode, the sample chamber is filled with sample.
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Accused Products
Abstract
A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry; and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.
464 Citations
24 Claims
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1. A sensor for determining a concentration of an analyte in a sample, the sensor comprising:
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a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a sensor comprising a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, a first side edge and a second side edge extending from the proximal end to the distal end of the sensor, and the proximal end of the sensor comprising first and second extensions; a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending with a substantially uniform width from the first aperture to the second aperture; a working electrode disposed on the first substrate; an analyte-responsive enzyme disposed on the working electrode; a counter electrode disposed on the second substrate, wherein the working electrode and the counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; an indicator electrode disposed on at least one of the first and second substrates and positioned relative to a sample flow path within the sample chamber to indicate that, when sample contacts the indicator electrode, the sample chamber is filled with sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A sensor for determining a concentration of analyte in a sample, the sensor comprising:
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a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a sensor comprising a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, a first side edge and a second side edge extending from the proximal end to the distal end of the sensor, and the proximal end of the sensor comprising first and second extensions; a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending with a substantially uniform width from the first aperture to the second aperture; a working electrode disposed on the first substrate; an analyte-responsive enzyme disposed on the working electrode; a counter electrode disposed on the second substrate, wherein the working electrode and the counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and an indicator electrode disposed on at least one of the first and second substrates and positioned relative to the sample chamber to determine when the sample chamber contains sample.
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23. A sensor for determining a concentration of analyte in a sample, the sensor comprising:
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a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a sensor comprising a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, a first side edge and a second side edge extending from the proximal end to the distal end of the sensor, and the proximal end of the sensor comprising first and second extensions; a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending with a substantially uniform width from the first aperture to the second aperture; a working electrode disposed on the first substrate; an analyte-responsive enzyme disposed on the working electrode; a counter electrode disposed on the second substrate, wherein the working electrode and the counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and an indicator electrode disposed on at least one of the first and second substrates, wherein the indicator electrode is configured and arranged to aid in electrolysis of the analyte.
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24. A sensor for determining a concentration of analyte in a sample, the sensor comprising:
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a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a sensor comprising a proximal end and a distal end, the distal end being configured and arranged for insertion into a sensor reader, a first side edge and a second side edge extending from the proximal end to the distal end of the sensor, and the proximal end of the sensor comprising first and second extensions; a spacer disposed between the first and second substrates and defining a first aperture along the first side edge of the sensor, a second aperture along the second side edge of the sensor, and a sample chamber extending with a substantially uniform width from the first aperture to the second aperture; a working electrode disposed on the first substrate; an analyte-responsive enzyme disposed on the working electrode; a counter electrode disposed on the second substrate, wherein the working electrode and the counter electrode are positioned relative to the sample chamber to generate an analyte-responsive signal when sample containing analyte is disposed in the sample chamber; and an indicator electrode disposed on at least one of the first and second substrates, wherein the indicator electrode comprises first and second indicator electrodes, the first indicator electrode is positioned relative to the sample chamber to determine when the sample chamber begins to fill with sample and the second indicator electrode is positioned relative to the sample chamber to determine when the sample chamber is filled with sample.
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Specification