Oxidizable species as an internal reference in control solutions for biosensors

• US 9,766,198 B2
• Filed: 12/10/2015
• Issued: 09/19/2017
• Est. Priority Date: 04/08/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Beer, Greg P., Wu, Huan-Ping
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US14/964,827
• Publication Number:
  US 20160091454A1
• Time in Patent Office: 649 Days
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control

Abstract

Testing of the performance of an electrochemical meter used to measure the presence of an analyte in a biological sample, particularly glucose in whole blood, includes introducing a control solution containing a predetermined amount of the analyte and a predetermined amount of an internal reference compound. The internal reference compound is selected such that it is oxidized at a potential greater than that used to oxidize the analyte, thereby making it possible to distinguish the control solution from a biological sample.

Claims

1. A method of distinguishing a control solution from a sample during operation of an electrochemical sensor, the electrochemical sensor measuring the amount of an analyte, the method comprising the acts of:

providing an electrochemical sensor having a working electrode, a counter electrode, a reagent, and a control solution, the reagent having a mediator, the control solution having an internal reference compound, a buffer, and a predetermined amount of analyte, the internal reference compound having a higher redox potential than the mediator, the internal reference compound being different from the buffer;

applying a first potential to the electrochemical sensor sufficient to oxidize the internal reference compound and the mediator, and measuring the resulting electrical current;

applying a second, lower potential to the electrochemical sensor, the lower potential being sufficient to oxidize the mediator and insufficient to oxidize the internal reference compound, and measuring the resulting electrical current; and

determining whether a control solution or a sample is present based on the measured electrical currents.

2. The method of claim 1, wherein the analyte is glucose and the biological sample is whole blood.

3. The method of claim 1, wherein the internal reference compound is an oxidizable organo-metallic compound, coordination compound, or organic amine compound.

4. The method of claim 3, wherein the internal reference compound is the organic amine compound, the organic amine compound being 3-(N-morpholino) propane sulfonic acid, N-(2-hydroxyethyl) piperazine-N¹-(2-ethane sulfonic acid), 2-[(2-Hydroxy-1,1-bis(hydroxy methyl)ethylamino] ethane sulfonic acid, 2-Morpholino ethane sulfonic acid, and Bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane [Bis-Tris], 4-aminobenzonitrile, 4-aminobenzoic acid, or 4-iodoaniline.

5. The method of claim 3, wherein the internal reference compound is the oxidizable organo-metallic compound, the oxidizable organo-metallic compound being ferrocene or ferrocene derivatives.

6. The method of claim 3, wherein the internal reference compound is the coordination compound, the coordination compound being potassium ferrocyanide.

7. The method of claim 1, wherein the internal reference compound has a redox potential that is at least 100 mV higher than the redox potential of the mediator.

8. The method of claim 1, wherein the first potential is at least 100 mV higher than the second potential.

9. The method of claim 1, wherein the first potential and the second potential are applied without a waiting period therebetween.

10. A method of distinguishing a control solution from a sample during operation of an electrochemical sensor, the electrochemical sensor measuring the amount of an analyte, the method comprising the acts of:

providing an electrochemical sensor having a working electrode, a counter electrode, a reagent, and a control solution, the reagent having a mediator, the control solution having a predetermined amount of an internal reference compound, a buffer, and a predetermined amount of analyte, the predetermined amount of the internal reference compound being dependent upon the predetermined amount of analyte;

applying a first potential to the electrochemical sensor sufficient to oxidize the internal reference compound and the mediator, and measuring the resulting electrical current;

applying a second potential to the electrochemical sensor, the second potential being at least 100 mV lower than the first potential, the second potential being sufficient to oxidize the mediator and insufficient to oxidize the internal reference compound, and measuring the resulting electrical current; and

determining whether a control solution or a sample is present based on the measured electrical currents.

11. The method of claim 10, wherein the analyte is glucose and the biological sample is whole blood.

12. The method of claim 10, wherein the internal reference compound is an oxidizable organo-metallic compound, coordination compound, or organic amine compound.

13. The method of claim 12, wherein the internal reference compound is the organic amine compound, the organic amine compound being 3-(N-morpholino) propane sulfonic acid, N-(2-hydroxyethyl) piperazine-N¹-(2-ethane sulfonic acid), 2-[(2-Hydroxy-1,1-bis(hydroxy methyl)ethylamino] ethane sulfonic acid, 2-Morpholino ethane sulfonic acid, and Bis(2-hydroxyethyl)amino-tris (hydroxymethyl) methane [Bis-Tris], 4-aminobenzonitrile, 4-aminobenzoic acid, or 4-iodoaniline.

14. The method of claim 12, wherein the internal reference compound is the oxidizable organo-metallic compound, the oxidizable organo-metallic compound being ferrocene or ferrocene derivatives.

15. The method of claim 12, wherein the internal reference compound is the coordination compound, the coordination compound being potassium ferrocyanide.

16. The method of claim 10, wherein the internal reference compound has a redox potential that is at least 100 mV higher than the redox potential required of the mediator.

17. The method of claim 10, wherein the buffer is different from the internal reference compound, the buffer and the internal reference compound being configured to serve different functions.