Determination of blood glucose in a small volume and in a short test time using short read potentials
First Claim
Patent Images
1. A method of determining the concentration of glucose in a blood sample, comprising:
- providing a disposable biosensor test strip including a capillary chamber having a depth suitable for capillary flow of blood, and holding a volume of from about 0.25 μ
l to less than 1 μ
l of the blood sample, a working electrode and a counter or reference electrode disposed within the capillary chamber, and a reagent proximal to or in contact with at least the working electrode, the reagent including an enzyme and a mediator;
applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample 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 capillary chamber;
following said detecting, applying an electrooxidation assay potential across the working and counter or reference electrodes;
electrooxidizing the electroactive reaction product at the working electrode, said electrooxidizing producing an assay current;
measuring the assay current at one or more times while applying the assay potential;
correlating the one or more assay current measurements to the concentration of glucose in the blood sample; and
within the time period lasting from about 2 seconds to about 8 seconds after said detecting, providing a readout of the glucose concentration in the blood sample.
5 Assignments
0 Petitions
Accused Products
Abstract
Analytes in a liquid sample are determined by methods utilizing sample volumes of less than about 1.0 μl and test times within about eight seconds. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.
12 Citations
64 Claims
-
1. A method of determining the concentration of glucose in a blood sample, comprising:
-
providing a disposable biosensor test strip including a capillary chamber having a depth suitable for capillary flow of blood, and holding a volume of from about 0.25 μ
l to less than 1 μ
l of the blood sample, a working electrode and a counter or reference electrode disposed within the capillary chamber, and a reagent proximal to or in contact with at least the working electrode, the reagent including an enzyme and a mediator;applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample 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 capillary chamber; following said detecting, applying an electrooxidation assay potential across the working and counter or reference electrodes; electrooxidizing the electroactive reaction product at the working electrode, said electrooxidizing producing an assay current; measuring the assay current at one or more times while applying the assay potential; correlating the one or more assay current measurements to the concentration of glucose in the blood sample; and within the time period lasting from about 2 seconds to about 8 seconds after said detecting, providing a readout of the glucose concentration in the blood sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
-
-
19. A method of determining the concentration of glucose in a blood sample, wherein the blood sample is added to a disposable, electrochemical biosensor test strip comprising:
-
providing the disposable, electrochemical bio sensor test strip including a capillary chamber having a depth suitable for capillary flow of blood, and holding a volume from about 0.25 to less than 1 μ
l of the blood sample, and a reagent within the capillary chamber, the reagent including an enzyme and a mediator;applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample 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 capillary chamber; following said detecting, electrooxidizing the electroactive reaction product, said electrooxidizing producing an assay current; measuring the assay current at one or more times, correlating the one or more assay current measurements to the concentration of glucose in the blood sample, and within the time period lasting from about 2 to about 8 seconds after said detecting, providing a readout of the glucose concentration in the blood sample. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
-
-
41. In an electrochemical method for determining the concentration of glucose in a blood sample, the method involving the use of a test strip including a capillary chamber having a depth suitable for capillary flow of blood and a reagent within the capillary chamber, the reagent including an enzyme and a mediator, the method further utilizing a test meter configured to receive and operate the test strip, the method comprising applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent, the glucose in the blood sample reacting with the reagent to produce an electroactive reaction product in an amount which correlates with the amount of glucose in the blood sample, the improvement comprising:
-
the capillary chamber holding from about 0.25 to less than 1 μ
l of the blood sample;detecting the blood sample in the capillary chamber; following said detecting, measuring an electrical current resulting from electrooxidation of the electroactive reaction product; correlating the measured electrical current with the glucose concentration in the blood sample; and within a period of time from about 2 seconds to about 8 seconds after said detecting, providing a readout of the glucose concentration on the test meter. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
-
Specification
-
- Resources
Litigation Campaign Assessment
Thank you for your request. You will receive a custom alert email when the Litigation Campaign Assessment is available.
×
-
Current AssigneeRoche Diabetes Care Inc. (Roche Holding AG)
-
Original AssigneeRoche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
-
InventorsWilsey, Christopher D.
-
Primary Examiner(s)Noguerola, Alex
-
Application NumberUS13/433,415Publication NumberTime in Patent Office257 DaysField of Search20440301-40315, 205/792, 205/777.5, 205/778US Class Current205/792CPC 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...
