METHOD FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A LIQUID SAMPLE USING SMALL VOLUME SAMPLES AND FAST TEST TIMES
First Claim
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1. A method of determining the concentration of glucose in a blood sample, comprising the acts of:
- providing a disposable, electrochemical biosensor test strip including a sample receiving cavity having a volume from about 0.3 μ
l to less than 1 μ
l, and a reagent within the sample receiving cavity, the reagent including an enzyme and a mediator;
applying a blood sample containing glucose into the sample receiving cavity and into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent, the glucose reacting with the reagent to produce an electroactive reaction product;
detecting the blood sample in the sample receiving cavity;
following said detecting, applying or controlling the potential across the sample receiving cavity producing an assay current;
within the time period from about 3.5 seconds to about 6 seconds after said detecting, measuring the assay current at one or more times and thereby obtaining one or more assay current measurements, andwithin the time period from about 3.5 seconds to about 6 seconds after said detecting, determining the concentration of glucose in the blood sample using the one or more assay current measurements.
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Abstract
Analytes in a liquid sample are determined by methods utilizing sample volumes from about 0.3 μl to less than 1 μl and test times from about 3.5 to about 6 seconds after detection of the sample. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.
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Citations
11 Claims
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1. A method of determining the concentration of glucose in a blood sample, comprising the acts of:
-
providing a disposable, electrochemical biosensor test strip including a sample receiving cavity having a volume from about 0.3 μ
l to less than 1 μ
l, and a reagent within the sample receiving cavity, the reagent including an enzyme and a mediator;applying a blood sample containing glucose into the sample receiving cavity and into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent, the glucose reacting with the reagent to produce an electroactive reaction product; detecting the blood sample in the sample receiving cavity; following said detecting, applying or controlling the potential across the sample receiving cavity producing an assay current; within the time period from about 3.5 seconds to about 6 seconds after said detecting, measuring the assay current at one or more times and thereby obtaining one or more assay current measurements, and within the time period from about 3.5 seconds to about 6 seconds after said detecting, determining the concentration of glucose in the blood sample using the one or more assay current measurements. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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Specification
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Current AssigneeRoche Diabetes Care Inc. (Roche Holding AG)
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Original AssigneeRoche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
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InventorsWilsey, Christopher D.
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current1/1
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CPC Class CodesC12Q 1/001 Enzyme electrodesC12Q 1/006 for glucoseG01N 27/307 Disposable laminated or mul...G01N 27/3272 Test elements therefor, i.e...G01N 27/3273 Devices therefor, e.g. test...G01N 27/3275 Sensing specific biomolecul...
