System and methods for automatically recognizing a control solution

• US 8,647,487 B2
• Filed: 02/11/2011
• Issued: 02/11/2014
• 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): Ball, J. Christopher
• Application Number:
  US13/025,203
• Publication Number:
  US 20110192721A1
• Time in Patent Office: 1,096 Days
• Field of Search: 205/775, 205/777.5, 205/778, 205/779, 204/400, 204/403.01, 204/403.04, 20440309-40311
• US Class Current: 204/403.04
• 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 having a known, predetermined concentration of an analyte and an actual patient/user sample in a biosensor comprising:

a sample reception region;

a reaction reagent system in said sample reception region comprising;

an oxidation-reduction enzyme specific for the analyte;

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

a second electron mediator, capable of being reversibly reduced and oxidized, wherein the second electron mediator has a redox potential different from that of the first mediator; and

a distinction system configured to detect the electro-chemical response signal produced by the reduction of the second electron mediator in order to identify a control solution.

2. The system of claim 1, wherein the control solution comprises the second electron mediator.

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

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

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

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

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

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

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

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

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

12. The system of claim 1, wherein the second electron mediator is 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.

13. The system of claim 1, wherein the distinction system comprises a meter configured to apply at least a first and a second electric pulse to the biosensor.

14. The system of claim 13, wherein the distinction system is configured to measure at least a first and a second current signal generated in response to at least the first and the second applied electric pulses.

15. The system of claim 13, wherein electric potentials of at least the first and the second applied electric pulses are of different magnitudes.

16. The system of claim 1, wherein the distinction system is configured to measure a hematocrit level of the control solution or the actual patient/user sample.