Small Volume In Vitro Analyte Sensor
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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. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as amperometric, voltammetric, and potentiometric techniques, can also be used.
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.
256 Citations
166 Claims
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1-132. -132. (canceled)
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133. An optical sensor for determining the concentration of an analyte, comprising:
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at least two support films, wherein at least one of said support film forms at least one boundary area wherein a biological fluid is analyzed, wherein said boundary area receives a volume no greater than 1.0 μ
L;at least one sorbent material associated with said boundary area; and a reagent layer including an enzyme-based composition. - View Dependent Claims (134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151)
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152. An optical sensor for determining the concentration of an analyte, comprising:
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at least two support films, wherein at least one of said support film forms at least one boundary area wherein a biological fluid is analyzed, wherein said boundary area includes at least one expanded region; and a reagent layer including an enzyme-based composition includes GDH-PQQ. - View Dependent Claims (153, 154, 155, 156, 157, 158, 159, 160, 161, 162)
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163. A method of using an optical sensor for determining the concentration of an analyte, comprising:
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providing at least two support films, wherein at least one of said support film forms at least one boundary area wherein a biological fluid is analyzed, wherein said boundary area receives a volume no greater than 1.0 μ
L;providing at least one sorbent material associated with said boundary area; and providing a reagent layer including an enzyme-based composition including GDH-PQQ.
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164. A method for using an optical sensor for determining the concentration of an analyte, comprising:
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providing at least two support films, wherein at least one of said support film forms at least one boundary area wherein a biological fluid is analyzed, wherein said boundary area includes at least one expanded region; and providing a reagent layer including an enzyme-based composition includes GDH-PQQ.
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165. An optical sensor for determining the concentration of an analyte, comprising:
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at least two support films, wherein at least one of said support film forms at least one boundary area wherein a biological fluid is analyzed, wherein at least a portion of at least one of said support films is transparent or translucent, wherein said boundary area receives a volume no greater than 1.0 μ
L;at least one expanded region associated with said boundary area at least one sorbent material associated with said boundary area; and a reagent layer including an enzyme-based composition including GDH-PQQ and a mediator, wherein said mediator is a dye specific to said desired analyte, wherein said dye includes a reflection spectra or is within the fluorescence of said mediator.
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166. An optical sensor for determining the concentration of an analyte, comprising:
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at least two support films, wherein at least one of said support film forms at least one boundary area wherein a biological fluid is analyzed, wherein said boundary area includes at least one expanded region; at least one spacer, wherein said spacer and at least one of said support film form said boundary area; and a reagent layer including an enzyme-based composition includes GDH-PQQ.
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Specification