System and methods for automatically recognizing a control solution

• US 20070256943A1
• Filed: 05/04/2006
• Published: 11/08/2007
• Est. Priority Date: 05/04/2006
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Davies, Stephen, Popovich, Natasha
• Granted Patent: US 7,909,983 B2
• Time in Patent Office: Days
• US Class Current: 205/777.500
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Methods and devices for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor are provided. The solution is introduced into an electrochemical cell having a working and counter electrode. Electric pulses are applied to the cell and resultant signals are measured. Based on a comparison of the measured signals, a meter can determine whether the sample is a control solution or an actual patient/user sample.

Claims

1. A system for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor comprising:

a sample reception region;

a reaction reagent system comprising;

an oxidation-reduction enzyme specific for an analyte; and

a first electron mediator capable of being reversibly reduced and oxidized; and

a distinction system configured to identify a control solution having a known, predetermined concentration of the analyte and a second electron mediator capable of capable of undergoing an electrochemical redox reaction.

2. The system of claim 1, wherein the analyte is glucose.

3. The system of claim 1, wherein the second electron mediator does not interfere with the measurement of the analyte.

4. The system of claim 1, wherein the first electron mediator is a ruthenium containing material.

5. The system of claim 4, wherein the ruthenium containing material comprises hexaamine (III) trichloride.

6. The system of claim 1, wherein the second mediator is Ferrocene Dicarboxylic Acid.

7. The system of claim 1, wherein the second mediator is Ferrocenecarboxylic Acid.

8. The system of claim 1, wherein the second mediator is gentisic acid (2,5-dihydroxybenzoic acid).

9. The system of claim 1, wherein the second mediator is 2,3,4-trihydroxybenzoic acid.

10. The system of claim 1, wherein the second mediator is oxidized or reduced in a potential range distinguishable from that of the first mediator.

11. The system of claim 1, wherein the second electron mediator is oxidized or reduced at a potential having a magnitude at least 0.2 volts greater or less than that used to oxidize or reduce the first electron mediator.

12. The system of claim 1, the wherein the redox potential of the first electron mediator is different from the redox potential of the second electron mediator.

13. A method for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor comprising:

(a) providing an electrochemical cell comprising;

(i) spaced apart working and counter electrodes; and

(ii) a redox reagent system comprising an enzyme specific for an analyte;

(b) introducing into the reaction cell, a control solution a having a known, predetermined concentration of the analyte;

(b) applying a first electric pulse to the reaction cell and measuring a first resulting electrical property of the cell;

(c) applying a second electric pulse to the cell and measuring a second resulting electrical property of the cell;

(d) comparing the first and second measurements; and

(e) determining the presence or absence of a control solution based on the results of the comparison performed in part (d).

14. The method of claim 13, wherein the analyte is glucose.

15. The method of claim 13, wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through multi-step chronoamperometry.

16. The method of claim 13, wherein the first and second electrical properties measured are electrochemical signals comprised electric current signals obtained through square wave voltammetry.

17. The method of claim 13, wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through differential pulse amperometry.

18. The method of claim 13, wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through cyclic voltammetry.

19. The method of claim 13, wherein providing an electrochemical cell comprises providing a first electron mediator capable of being reversibly reduced and oxidized and wherein the control solution includes a second electron mediator capable of capable of undergoing an electrochemical redox reaction.

20. The method of claim 19, wherein step (b) results in an oxidation or reduction of the first mediator and step (c) results in oxidation or reduction of the second mediator.

21. The method of claim 20, wherein the second electron mediator is oxidized or reduced at a potential having a magnitude at least 0.2 volts greater or less than that used to oxidize or reduce the first electron mediator.

22. The method of claim 20, wherein the redox potential of the first electron mediator is different from the redox potential of the second electron mediator.

23. The method of claim 19, wherein the second mediator is Ferrocene Dicarboxylic Acid.

24. The method of claim 19, wherein the second mediator is Ferrocenecarboxylic Acid.

25. The method of claim 19, wherein the second mediator is gentisic acid (2,5-dihydroxybenzoic acid).

26. The method of claim 19, wherein the second mediator is 2,3,4-trihydroxybenzoic acid.

27. A fluid control solution for use in calibrating a biosensor system comprising:

a known, predetermined concentration of an analyte and

an electron mediator capable of capable of undergoing an electrochemical redox reaction.

28. The fluid control solution of claim 27, wherein the control solution is configured for use in a biosensor system having an oxidation-reduction enzyme specific for the analyte and a second electron mediator capable of being reversibly reduced and oxidized;

and wherein the electron mediator of the control solution is oxidized or reduced at a potential having a magnitude at least 0.2 volts greater or less than that used to oxidize or reduce the second electron mediator.

29. The fluid control solution of claim 27, wherein the control solution is configured for use in a biosensor system having an oxidation-reduction enzyme specific for the analyte and a second electron mediator capable of being reversibly reduced and oxidized;

and wherein the redox potential of the electron mediator for the control solution is different from the redox potential of the second electron mediator.

30. The fluid control solution of claim 27, wherein the electron mediator is Ferrocene Dicarboxylic Acid.

31. The fluid control solution of claim 27, wherein the electron mediator is Ferrocenecarboxylic Acid.

32. The fluid control solution of claim 27, wherein the electron mediator is gentisic acid (2,5-dihydroxybenzoic acid).

33. The fluid control solution of claim 27, wherein the electron mediator is 2,3,4-trihydroxybenzoic acid.

34. The fluid control solution of claim 27, wherein the analyte is glucose.