System and methods for automatically recognizing a control solution

• US 7,909,983 B2
• Filed: 05/04/2006
• Issued: 03/22/2011
• Est. Priority Date: 05/04/2006
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Popovich, Natasha D., Davies, Stephen G.
• Primary Examiner(s): Ruddock; Ula C
• Assistant Examiner(s): Kaur; Gurpreet
• Application Number:
  US11/417,225
• Publication Number:
  US 20070256943A1
• Time in Patent Office: 1,783 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.04, 204/403.14, 205/777.5, 205/792, 205/779
• US Class Current: 205/777.5
• 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 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 dry reaction reagent system comprising;

an oxidation-reduction enzyme specific for an analyte;

a first reversible redox species capable of being an electron mediator for the oxidation-reduction enzyme; and

a second reversible redox species, wherein the second redox species has a redox potential different from that of the first redox species;

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

(c) applying at least one electric pulse configured to oxidize or reduce only the first redox species to the electrochemical cell and measuring a first resulting electrical property of the cell;

(d) applying at least one electric pulse configured to oxidize or reduce only the second redox species to the cell and measuring a second resulting electrical property of the cell;

(e) comparing the first and second measurements; and

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

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

3. The method of claim 1, wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through multi-step chronoamperometry.

4. The method of claim 1, wherein the first and second electrical properties measured are electrochemical signals comprised electric current signals obtained through square wave voltammetry.

5. The method of claim 1, wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through differential pulse amperometry.

6. The method of claim 1, wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through cyclic voltammetry.

7. The method of claim 1, wherein the second reversible redox species 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.

8. The method of claim 1, wherein the redox potential of the first reversible redox species is different from the redox potential of the second electron mediator.

9. The method of claim 1, wherein the second reversible redox species is Ferrocene Dicarboxylic Acid.

10. The method of claim 1, wherein the second reversible redox species is Ferrocenecarboxylic Acid.

11. The method of claim 1, wherein the second reversible redox species is gentisic acid (2,5-dihydroxybenzoic acid).

12. The method of claim 1, wherein the second reversible redox species is 2,3,4-trihydroxybenzoic acid.