Small Volume in Vitro Analyte Sensor
3 Assignments
0 Petitions
Accused Products
Abstract
A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 μL. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as an enzyme, can be added to facilitate the electrooxidation or electroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable.
The amount of analyte can be determined by coulometry, amperometry, voltammetry, and potentiometry. 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. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is provided as a second electron transfer agent.
-
Citations
152 Claims
-
1-132. -132. (canceled)
-
133. A method for determining a concentration of an analyte in a sample from a patient, the method comprising:
-
(a) contacting the patient with an integrated sample acquisition and analyte measurement device comprising a sample acquisition means and an electrochemical sensor, the integrated device comprising; (i) a spacer layer; (ii) a first inert base having a first electrode thereon, the first base positioned against the spacer layer with the first electrode proximate the spacer layer; (iii) a second inert base having a second electrode thereon, the second base positioned against the spacer layer with the second electrode proximate the spacer layer, the first and second electrodes being a facing electrode pair; (iv) the spacer layer, first base and second base together defining a measurement zone less than 1.0 microliter; (v) a redox mediator and an enzyme present in the measurement zone; and (vi) a skin piercing member; (b) piercing the patient with the sample acquisition means to obtain the sample; (c) transporting a portion of the sample to the measurement zone of the sensor; and (d) determining the concentration of analyte in the sample by electrochemistry. - View Dependent Claims (134, 135, 136, 137, 138, 139, 140, 141, 142)
-
-
143. A method for determining a concentration of an analyte in a sample from a patient, the method comprising:
-
(a) piercing the patient with a sample acquisition means to obtain the sample, the sample acquisition means being part of an integrated device comprising the sample acquisition means and an analyte sensor, the analyte sensor comprising; (i) a first inert base and a second inert base; (ii) a first electrode and a second electrode; (iii) a sample chamber for receiving and holding the sample in electrolytic contact with the first electrode and the second electrode, the sample chamber extending to an edge of the sensor and forming an opening therein between the bases; (iv) a measurement zone within the sample chamber having a volume less than 1.0 microliter; and (v) a redox mediator and an enzyme present in the measurement zone; (b) transporting a portion of the sample to the measurement zone of the sensor; and (c) determining the concentration of analyte in the sample by electrochemistry. - View Dependent Claims (144, 145, 146, 147, 148, 149, 150, 151, 152)
-
Specification