Determination of blood glucose in a small volume and in a short test time using a chemical coating including binders and very short read potentials

• US 8,349,168 B2
• Filed: 03/29/2012
• Issued: 01/08/2013
• 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:
  US13/433,779
• Publication Number:
  US 20120181188A1
• Time in Patent Office: 285 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 eight 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, 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 0.25 μ

l to less than 1 μ

l of the blood sample, the capillary chamber including a working electrode, a counter or reference electrode, and a chemical coating, the chemical coating being proximal to at least the working electrode, the chemical coating including a chemical reagent proximal to or in contact with at least the working electrode and including an enzyme and a mediator, the chemical coating further including one or more binders;

applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample into contact with the chemical reagent to cause the blood sample to at least partially solubilize or hydrate the chemical reagent, the glucose reacting with the chemical reagent to produce an electroactive reaction product;

detecting the blood sample in the capillary chamber;

following said detecting, providing a delay period prior to the application of an electrooxidation assay potential of about 100 mV to about 500 mV across the working and counter or reference electrode;

following said delay period, applying an electrooxidation assay potential of about 100 mV to about 500 mV across the working and counter or reference electrodes for a period of about 1.5 seconds to about 6 seconds;

electrooxidizing the electroactive reaction product at the working electrode, said electrooxidizing producing an assay current;

measuring the assay current at one or more times during application of the assay potential;

correlating the one or more assay current measurements to the concentration of glucose in the blood sample; and

from about 2 seconds to about 8 seconds after said detecting, providing a readout of the glucose concentration in the blood sample.

2. The method of claim 1 in which the delay period comprises a period of time during which no potential in the range of 200 mV to 400 mV is applied, and in which said applying an assay potential comprises applying a potential of 200 mV to 400 mV.

3. The method of claim 1 in which the one or more binders comprises one or more components selected from the group consisting of gelatin, carrageenan, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, alginate, polyethylene oxide, alginic acid, hydroxyethylcellulose, carboxymethylcellulose, microcrystalline cellulose, and combinations thereof.

4. The method of claim 3 in which the one or more binders comprises one or more components selected from the group consisting of gelatin, carrageenan, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, alginate, polyethylene oxide, alginic acid, hydroxyethylcellulose, and combinations thereof.

5. The method of claim 3 in which the one or more binders comprises one or more components selected from the group consisting of gelatin, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene oxide, hydroxyethylcellulose, carboxymethylcellulose, and combinations thereof.

6. The method of claim 3 in which said applying comprises applying the electrooxidation assay potential for a period of about 1.5 seconds to about 3 seconds.

7. The method of claim 6 which includes, following said detecting, providing a delay period of about 3 seconds prior to application of the electrooxidation potential across the working and counter or reference electrodes.

8. The method of claim 7 in which the capillary chamber holds a volume of about 0.6 μ

l, and which comprises providing a readout of the glucose concentration about 5 seconds after said detecting.

9. The method of claim 3 in which said applying comprises applying the electrooxidation assay potential for a period of about 1.5 seconds.

10. The method of claim 9 which includes, following said detecting, providing a delay period of less than about 2 seconds prior to application of the electrooxidation potential across the working and counter or reference electrodes.

11. The method of claim 10 which comprises providing a readout of the glucose concentration about 5 seconds after said detecting.

12. The method of claim 9 which includes, following said detecting, providing a delay period of less than about 3 seconds prior to application of the electrooxidation potential across the working and counter or reference electrodes.

13. The method of claim 12 in which the capillary chamber holds a volume of about 0.6 μ

l, and which comprises providing a readout of the glucose concentration in about 8 seconds after said detecting.

14. The method of claim 9 which includes, following said detecting, providing a delay period of less than about 1 second prior to application of the electrooxidation potential across the working and counter or reference electrodes.

15. The method of claim 14 in which the capillary chamber holds a volume of about 0.6 μ

l, and which comprises providing a readout of the glucose concentration in about 8 seconds after said detecting.

16. The method of claim 1 in which said applying the electrooxidation assay potential immediately follows the delay period.

17. 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 0.25 μ

l to less than 1 μ

l of the blood sample, the capillary chamber including a working electrode, a counter or reference electrode, and a chemical coating, the chemical coating being proximal to at least the working electrode, the chemical coating including a chemical reagent proximal to or in contact with at least the working electrode and including an enzyme and a mediator, the chemical coating further including one or more binders;

applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample into contact with the chemical reagent to cause the blood sample to at least partially solubilize or hydrate the reagent, the glucose reacting with the chemical reagent to produce an electroactive reaction product;

detecting the blood sample in the capillary chamber;

following said detecting, providing a delay period prior to application of an electrooxidation assay potential of about 100 mV to about 500 mV across the working and counter or reference electrode;

following said delay period, applying an electrooxidation assay potential of about 100 mV to about 500 mV 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 during application of the assay potential at one or more times from about 1.5 seconds to about 6 seconds after first applying the assay potential;

correlating the one or more assay current measurements to the concentration of glucose in the blood sample; and

from about 2 seconds to about 8 seconds after said detecting, providing a readout of the glucose concentration in the blood sample.

18. The method of claim 17 in which the delay period comprises a period of time during which no potential in the range of 200 mV to 400 mV is applied, and in which said applying an assay potential comprises applying a potential of 200 mV to 400 mV.

19. The method of claim 17 in which the one or more binders comprises one or more components selected from the group consisting of gelatin, carrageenan, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, alginate, polyethylene oxide, alginic acid, hydroxyethylcellulose, carboxymethylcellulose, microcrystalline cellulose, and combinations thereof.

20. The method of claim 19 in which said measuring comprises measuring the assay current at one or more times from about 1.5 seconds to about 3 seconds after first applying the assay potential.

21. The method of claim 20 which includes, following said detecting, providing a delay period of about 3 seconds prior to application of the electrooxidation potential across the working and counter or reference electrodes.

22. The method of claim 21 in which the capillary chamber holds a volume of about 0.6 μ

l, and which comprises providing a readout of the glucose concentration about 5 seconds after said detecting.

23. The method of claim 17 in which said measuring comprises measuring the assay current at one or more times about 1.5 seconds after first applying the assay potential.

24. The method of claim 23 which includes, following said detecting, providing a delay period of less than about 2 seconds prior to application of the electrooxidation potential across the working and counter or reference electrodes.

25. The method of claim 24 which comprises providing a readout of the glucose concentration about 5 to about 8 seconds after said detecting.

26. The method of claim 23 which includes, following said detecting, providing a delay period of less than about 3 seconds prior to application of the electrooxidation potential across the working and counter or reference electrodes.

27. The method of claim 26 in which the capillary chamber holds a volume of about 0.6 μ

l, and which comprises providing a readout of the glucose concentration in about 8 seconds after said detecting.

28. The method of claim 23 which includes, following said detecting, providing a delay period of less than about 1 second prior to application of the electrooxidation potential across the working and counter or reference electrodes.

29. The method of claim 28 in which the capillary chamber holds a volume of about 0.6 μ

l, and which comprises providing a readout of the glucose concentration in about 8 seconds after said detecting.

30. 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 0.25 μ

l to less than 1 μ

l of the blood sample, the capillary chamber including a working electrode, a counter or reference electrode, and a chemical coating, the chemical coating being proximal to at least the working electrode, the chemical coating including a chemical reagent proximal to or in contact with at least the working electrode and including an enzyme and a mediator, the chemical coating further including one or more binders;

applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample into contact with the chemical reagent to cause the blood sample to at least partially solubilize or hydrate the chemical reagent, the glucose reacting with the chemical reagent to produce an electroactive reaction product;

detecting the blood sample in the capillary chamber;

following said detecting, providing a delay period prior to application of an electrooxidation assay potential of about 100 mV to about 500 mV across the working and counter or reference electrode;

following said delay period, applying an electrooxidation assay potential of about 100 mV to about 500 mV across the working and counter or reference electrodes for a period of about 1.5 seconds to about 6 seconds;

electrooxidizing the electroactive reaction product at the working electrode, said electrooxidizing producing an assay current;

measuring the assay current during application of the assay potential at one or more times from about 1.5 seconds to about 6 seconds after first applying the assay potential;

correlating the assay current measurement to the concentration of glucose in the blood sample; and

from about 2 seconds to about 8 seconds after said detecting, providing a readout of the glucose concentration in the blood sample.

31. The method of claim 30 in which the one or more binders comprises one or more components selected from the group consisting of gelatin, carrageenan, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, alginate, polyethylene oxide, alginic acid, hydroxyethylcellulose, carboxymethylcellulose, microcrystalline cellulose, and combinations thereof.

32. The method of claim 31 in which said applying comprises applying the electrooxidation assay potential for a period of about 1.5 seconds to about 3 seconds, and in which said measuring comprises measuring the assay current at one or more times from about 1.5 seconds to about 3 seconds after first applying the assay potential.

33. The method of claim 31 in which said applying comprises applying the electrooxidation assay potential for a period of about seconds to about 1.5 seconds, and in which said measuring comprises measuring the assay current at one or more times about 1.5 seconds after first applying the assay potential.