Small Volume In Vitro Analyte Sensor and Methods of Making
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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.
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Citations
36 Claims
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1-11. -11. (canceled)
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12. A method of determining a concentration of an analyte in blood, the method comprising steps of:
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stimulating a region of abdomen skin by manually rubbing the abdomen skin; after stimulating the region of the abdomen skin, lancing the abdomen skin to cause a flow of blood from the region; contacting a sensor strip to the blood and transporting the blood to a sample chamber in the sensor strip; and determining the concentration of the analyte. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A method of determining a concentration of glucose in blood, the method comprising steps of:
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stimulating a region of abdomen skin by manually rubbing the abdomen skin for at least one second; after stimulating the region of the abdomen skin, lancing the abdomen skin to cause a flow of blood from the region; contacting an electrochemical sensor strip to the blood and transporting no more than about 1 microliter of the blood to a sample chamber in the sensor strip, wherein the electrochemical sensor strip comprises; a working electrode and a counter electrode, wherein the working electrode and the counter electrode are separated by a closest distance no greater than 1000 μ
m, andglucose dehydrogenase and a diffusible redox mediator disposed proximate to the working electrode; and determining the concentration of the glucose using coulometry, amperometry, or potentiometry. - View Dependent Claims (33, 34, 35, 36)
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Specification