Control markers for auto-detection of control solution and method of use

• US 8,337,691 B2
• Filed: 12/10/2008
• Issued: 12/25/2012
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Lin, Jing, Tsai, Fu Hsiung, Wu, Huan-Ping, Ellis, Nicole D., Arndt, Henry C.
• Primary Examiner(s): Olsen, Kaj K
• Application Number:
  US12/316,133
• Publication Number:
  US 20090148875A1
• Time in Patent Office: 1,476 Days
• Field of Search: 204/403.01, 204/403.02, 204/406, 205/777.5, 205/792
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 2496/00 Reference solutions for assays of biological material
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• 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 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/13 Tracers or tags
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Claims

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

(a) adding to the control solution a control marker, the control marker being adapted to be electrochemically oxidized at a potential higher than the potential needed to measure the oxidation of the analyte, the control marker including sodium iodide, triethanolamine, cresol red, 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-amino salicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOOS), 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or a salt thereof;

(b) introducing the control solution, the control marker and a predetermined amount of the analyte to the electrochemical test sensor, the test sensor including a first electrode, a second electrode and a reagent;

(c) at least once applying a potential to the test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current;

(d) at least once applying a potential to the electrochemical test sensor lower than the potential of (c), the potential being sufficient to measure oxidation of the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and

(e) 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 sample is whole blood.

3. The method of claim 1 wherein the control marker is sodium iodide.

4. The method of claim 1 wherein the control marker is triethanolamine.

5. The method of claim 1 wherein the control marker is 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid or a salt thereof.

6. The method of claim 1 wherein the control marker is sodium diphenylamine-4-sulfonate.

7. The method of claim 1 wherein the control marker is cresol red.

8. The method of claim 1 wherein the potential of (c) is applied before the potential of (d) is applied.

9. The method of claim 1 wherein the potential of (d) is applied before the potential of (c).

10. The method of claim 1 wherein the control marker is 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOOS), 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or a salt thereof.

11. The method of claim 1 wherein the control marker is 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS) or a salt thereof.

12. The method of claim 1 wherein the control marker is 2-napthylamine 1-sulfonic acid, or a salt thereof.

13. The method of claim 1 wherein the control marker is sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or a salt thereof.

14. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor, the electrochemical test sensor measuring the information related to an analyte, the method comprising the acts of:

providing a control solution including an control marker and a predetermined amount of analyte, the control marker having a higher potential than the potential needed to measure the oxidation of the analyte, the control marker including sodium iodide, triethanolamine, cresol red, 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOOS), 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or a salt thereof;

providing an electrochemical test sensor having a first electrode, a second electrode and a reagent;

introducing the control solution to the electrochemical test sensor;

applying a potential to the electrochemical test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current;

applying a lower potential to the electrochemical test sensor, the lower potential being sufficient to oxidize the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and

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

15. The method of claim 14 wherein the analyte is glucose.

16. The method of claim 14 wherein the control marker is sodium iodide.

17. The method of claim 14 wherein the control marker is triethanolamine.

18. The method of claim 14 wherein the control marker is 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid or a salt thereof.

19. The method of claim 14 wherein the control marker is sodium diphenylamine-4-sulfonate.

20. The method of claim 14 wherein the control marker is cresol red.

21. The method of claim 14 wherein the lower potential is applied after the potential to the electrochemical test sensor sufficient to oxidize the control marker and the analyte is applied.

22. The method of claim 14 wherein the lower potential is applied before the potential to the electrochemical test sensor sufficient to oxidize the control marker and the analyte is applied.

23. The method of claim 14 wherein the control marker is 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS) or a salt thereof.

24. The method of claim 14 wherein the control marker is 8-anilino-1-naphthalenesulfonic acid, 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, or a salt thereof.

25. The method of claim 14 wherein the control marker is sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or a salt thereof.

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

(a) adding to the control solution a control marker, the control marker being adapted to be electrochemically oxidized at a potential higher than the potential needed to measure the oxidation of the analyte, the control marker including tripropanolamine, tributanolamine, xylenol orange, hydroquinone sulfonic acid or a salt thereof;

(b) introducing the control solution, the control marker and a predetermined amount of the analyte to the electrochemical test sensor, the test sensor including a first electrode, a second electrode and a reagent;

(c) at least once applying a potential to the test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current;

(d) at least once applying a potential to the electrochemical test sensor lower than the potential of (c), the potential being sufficient to measure oxidation of the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and

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

27. The method of claim 26 wherein the analyte is glucose and the sample is whole blood.

28. The method of claim 26 wherein the control marker is tripropanolamine.

29. The method of claim 26 wherein the control marker is tributanolamine.

30. The method of claim 26 wherein the control marker is xylenol orange.

31. The method of claim 26 wherein the control marker is hydroquinone sulfonic acid or a salt thereof.

32. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor, the electrochemical test sensor measuring the information related to an analyte, the method comprising the acts of:

providing a control solution including an control marker and a predetermined amount of analyte, the control marker having a higher potential than the potential needed to measure the oxidation of the analyte, the control marker including tripropanolamine, tributanolamine, xylenol orange, hydroquinone sulfonic acid or a salt thereof;

providing an electrochemical test sensor having a first electrode, a second electrode and a reagent;

introducing the control solution to the electrochemical test sensor;

applying a potential to the electrochemical test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current;

applying a lower potential to the electrochemical test sensor, the lower potential being sufficient to oxidize the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and

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

33. The method of claim 32 wherein the analyte is glucose.

34. The method of claim 32 wherein the control marker is tripropanolamine.

35. The method of claim 32 wherein the control marker is tributanolamine.

36. The method of claim 32 wherein the control marker is xylenol orange.

37. The method of claim 32 wherein the control marker is hydroquinone sulfonic acid or a salt thereof.