IP Library Granted Patent US 9,017,543
Granted Patent B2
US 9,017,543 · App. 13/856,483 · Granted Apr 28, 2015

Method for determining the concentration of an analyte in a liquid sample using small volume samples and fast test times

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Quick Facts
Patent No.
US 9,017,543
App. No.
13/856,483
Granted
Apr 28, 2015
Kind
B2
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.

Claims (19)

1. A method of determining the concentration of glucose in a blood sample, comprising:

providing a disposable, electrochemical biosensor test strip including a sample receiving cavity having a volume from about 0.3 μl to less than about 1 μl, 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, electrooxidizing the electroactive reaction product, said electrooxidizing 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.

2. The method of claim 1 , wherein said determining comprises determining the concentration of glucose in the blood sample for any glucose concentration in the range of 0-600 mg glucose/dL of blood.

3. The method of claim 1 , wherein the sample receiving cavity has a height of at least 100 μm.

4. The method of claim 1 , wherein said measuring the assay current comprises measuring the assay current from about 4 seconds to about 5 seconds after said detecting, and

wherein said determining the concentration of glucose comprises determining the concentration from about 4 seconds to about 5 seconds after said detecting.

5. The method of claim 1 , wherein the sample receiving cavity has a volume from about 0.3 μl to about 0.6 μl.

6. The method of claim 5 , wherein said determining comprises determining the concentration of glucose in the blood sample for any glucose concentration in the range of 0-600 mg glucose/dL of blood.

7. The method of claim 5 , wherein the sample receiving cavity has a height of at least 100 μm.

8. The method of claim 5 , wherein said measuring the assay current comprises measuring the assay current from about 4 seconds to about 5 seconds after said detecting, and

wherein said determining the concentration of glucose comprises determining the concentration from about 4 seconds to about 5 seconds after said detecting.

9. The method of claim 1 , wherein the sample receiving cavity has a volume from about 0.3 μl to about 0.4 μl.

10. The method of claim 1 , wherein the sample receiving cavity has a volume of about 0.3 μl.

11. The method of claim 1 , wherein the sample receiving cavity has a volume from about 0.4 μl to about 0.6 μl.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2024
From: ROCHE OPERATIONS LTD.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 067204/0694 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2015
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 036008/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 25, 2013
From: WILSEY, CHRISTOPHER D.
To: ROCHE DIAGNOSTICS CORPORATION
Reel/Frame 030677/0049 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 25, 2013
From: ROCHE DIAGNOSTICS CORPORATION
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 030677/0127 →
CHANGE OF NAME Recorded Jun 25, 2013
From: CORANGE INTERNATIONAL LIMITED
To: ROCHE OPERATIONS LTD.
Reel/Frame 030677/0276 →
ASSIGNMENT OF AN UNDIVIDED ONE-HALF INTEREST Recorded Jun 25, 2013
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: CORANGE INTERNATIONAL LIMITED
Reel/Frame 030677/0338 →