Amperometric biosensor test strip
First Claim
1. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
- a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, and a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor.
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Accused Products
Abstract
A reagent and method for determining the levels of 3-hydroxybutyric acid in a sample are provided. The reagent comprises a ferricyanide salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, and a catalytic amount of a second enzyme operative to catalyze the oxidization of the cofactor and the reduction of the ferricyanide. The reagent is incorporated into a test strip that generates an electrical output signal indicative of the level of 3-hydroxybutyric acid when the reagent is contacted with a sample.
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Citations
30 Claims
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1. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
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a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, and a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
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a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and being reactive with the sample in a manner effective to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, and a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor, wherein the reagent further comprises a filler. - View Dependent Claims (16)
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17. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
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a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and being reactive with the sample in a manner effective to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor, and a polymer selected from the group consisting of polyethylene glycol/polyethylene oxide, polyvinyl-alcohol, polyvinyl-pyrrholidine, polystyrene sulfonate, polyvinyl-acetate and microemulsions of vinyl-acetate.
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18. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
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a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and being reactive with the sample in a manner effective to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor, and a surfactant. - View Dependent Claims (19)
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20. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
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a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and being reactive with the sample in a manner effective to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor, and an inorganic buffer. - View Dependent Claims (21)
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22. A single-use disposable test strip apparatus for detecting 3-hydroxybutyric acid in a liquid sample, the apparatus comprising:
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a substrate, at least one electrode positioned on the substrate, and a single-use reagent in communication with the at least one electrode, the reagent being formed to dissolve in the liquid sample and being reactive with the sample in a manner effective to generate an electrical output signal indicative of the level of 3-hydroxybutyric acid in the sample, said reagent comprising a hexacyanoferrate (III) salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, a catalytic amount of a second enzyme operative to catalyze the electrochemical oxidation of a reduced form of the cofactor, and stabilizers selected from the group consisting of flavin mononucleotide, adenosine diphosphate, magnesium ions, lactose, and raffinose.
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23. A method for determining information indicative of the level of 3-hydroxybutyric acid in a liquid sample, the method comprising the steps of:
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reacting the sample with a single-use reagent formed to dissolve in the liquid sample, the reagent comprising a ferricyanide salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the sample, a cofactor corresponding to said first enzyme, and a catalytic amount of a second enzyme operative to catalyze the oxidization of the cofactor and the reduction of the ferricyanide, generating an electrical output from the dissolved reagent indicative of the level of 3-hydroxybutyric acid in the sample, measuring the electrical output; and
determining the level of 3-hydroxybutyric acid in the sample using information comprising the measured electrical output. - View Dependent Claims (24, 25, 26)
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27. A method for determining information indicative off the level of 3-hydroxybutyric acid in a liquid sample, the method comprising the steps of:
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providing a single-use disposable sensor including a working and counter electrodes and a reagent in communication with the electrodes, the reagent being formed to dissolve in the liquid sample and comprising a ferricyanide salt, a catalytic amount of a first enzyme operative to catalyze the oxidation of 3-hydroxybutyric acid in the fluid sample, a cofactor corresponding to said first enzyme, and a catalytic amount of a second enzyme operative to catalyze the oxidization of the cofactor and the reduction of the ferricyanide, contacting the reagent with the liquid sample, and applying a direct potential difference between the electrodes sufficient to generate an electrical output from the dissolved reagent indicative of the level of 3-hydroxybutyric acid in the fluid sample. - View Dependent Claims (28, 29, 30)
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Specification