Determination of blood glucose in a small volume and in a short test time

• US 8,298,401 B2
• Filed: 03/28/2012
• Issued: 10/30/2012
• Est. Priority Date: 11/16/2001
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Wilsey, Christopher D.
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US13/432,648
• Publication Number:
  US 20120181187A1
• Time in Patent Office: 216 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction

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 six seconds. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Claims

1. 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 biosensor test strip including a capillary chamber having a depth suitable for capillary flow of blood, and holding a volume from about 0.2 to about 0.6 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, providing a delay period prior to electrooxidizing the electroactive reaction product;

following said delay period, electrooxidizing the electroactive reaction product, said electrooxidizing producing an assay current;

measuring the assay current at one or more times after the delay period, correlating the one or more assay current measurements to the concentration of glucose in the blood sample, and

within a period of time from about 4 to about 6 seconds after said detecting, providing a readout of the glucose concentration in the blood sample.

2. The method of claim 1 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample.

3. The method of claim 1 in which said providing comprises providing a readout in about 5 seconds.

4. The method of claim 3 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample.

5. The method of claim 1 in which the delay period is about 3 seconds to about 5 seconds.

6. The method of claim 5 in which the delay period is about 4 seconds.

7. The method of claim 1 in which said measuring comprises measuring the assay current at one or more times from about 3 seconds to about 6 seconds after said detecting.

8. The method of claim 7 in which said measuring comprises measuring the assay current at one or more times from about 4 to about 5 seconds after said detecting.

9. The method of claim 8 in which the delay period is about 4 seconds.

10. The method of claim 9 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample.

11. The method of claim 10 in which said providing comprises providing a readout in about 5 seconds.

12. The method of claim 1 in which the test strip includes a working electrode and a counter or reference electrode within the capillary chamber, the reagent being located adjacent to at least the working electrode, said electrooxidizing comprising applying an electrooxidizing potential to the working electrode.

13. The method of claim 12 in which the electrodes have width and separation suitable for measuring the current due to electrooxidation of the electroactive reaction product.

14. The method of claim 13 in which the electrodes are configured for measuring the assay current due to the electrooxidation of the electroactive reaction product in the blood sample.

15. The method of claim 14 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample, and in which said providing comprises providing a readout in about 5 seconds.

16. The method of claim 15 in which the delay period is about 4 seconds.

17. The method of claim 16 in which said measuring comprises measuring the assay current at one or more times from about 4 to about 5 seconds after said detecting.

18. The method of claim 14 in which the working electrode includes one or more electrically connected electrode elements having an aggregate width of about 100 μ

m to about 1350 μ

m.

19. The method of claim 18 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample, the delay period is about 4 seconds, said measuring comprises measuring the assay current at one or more times from about 4 to about 5 seconds after said detecting, and said providing comprises providing a readout in about 5 seconds.

20. The method of claim 14 in which the working electrode includes one or more electrically connected electrode elements having an aggregate area of 0.1 mm² to 1.4 mm².

21. The method of claim 20 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample, the delay period is about 4 seconds, said measuring comprises measuring the assay current at one or more times from about 4 to about 5 seconds after said detecting, and said providing comprises providing a readout in about 5 seconds.

22. 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 0.2 to about 0.6 μ

l of the blood sample;

detecting the blood sample in the capillary chamber;

following said detecting and within a period of time from about 3 seconds to about 5 seconds after 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 4 seconds to about 6 seconds after said detecting, providing a readout of the glucose concentration on the test meter.

23. The improvement of claim 22 and which includes, following said detecting and prior to said measuring, providing a delay period of about 3 to about 5 seconds before electrooxidizing the electroactive reaction product.

24. The improvement of claim 23, wherein the delay period is about 4 seconds, said measuring being within a period of time from about 4 seconds to about 5 seconds after said detecting.

25. The improvement of claim 24, wherein the glucose concentration is displayed on the test meter about 5 seconds after said detecting.

26. The improvement of claim 25 in which the capillary chamber holds a volume of about 0.4 μ

l of the blood sample.