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 forearm skin by manually rubbing the forearm skin; after stimulating the region of the forearm skin, lancing the forearm skin to cause a flow of blood from the region, wherein the lancing is by using a lancing member of an integrated lancing and analyte sensor device comprising the lancing member and an analyte sensor member; contacting the analyte sensor member of the integrated lancing and analyte sensor device to the blood and transporting the blood to a sample chamber in the sensor member; 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 forearm skin by manually rubbing the forearm skin for at least one second; after stimulating the region of the forearm skin, lancing the forearm skin to cause a flow of blood from the region, wherein the lancing is by using a lancing member of an integrated lancing and analyte sensor device comprising the lancing member and an analyte sensor member comprising an electrochemical sensor strip; contacting the 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 100 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