Method of using a control solution and preparing for testing using the same

• US 8,871,517 B2
• Filed: 12/13/2013
• Issued: 10/28/2014
• 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): Wallenhorst, Maureen
• Application Number:
  US14/105,839
• Publication Number:
  US 20140106459A1
• Time in Patent Office: 319 Days
• Field of Search: 436/8, 436/14, 436/56, 436/63, 436/95, 436/149, 436/150, 252/408.1, 435/14, 205/792, 205/777.5, 204/403.01
• US Class Current: 436/14
• 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 using a control solution and preparing for testing using the same, the method comprising:

providing a control solution, the control solution including a control marker and a predetermined amount of analyte, the control marker being selected from the group consisting of sodium iodide, triethanolamine, tripropanolamine, tributanolamine, xylenol orange, hydroquinone sulfonic acid, cresol red, and salts thereof;

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

introducing the control solution including the control marker and the predetermined amount of analyte to the electrochemical test sensor.

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

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 tripropanolamine.

6. The method of claim 1 wherein the control marker is tributanolamine.

7. The method of claim 1 wherein the control marker is xylenol orange.

8. The method of claim 1 wherein the control marker is hydroquinone sulfonic acid or salts thereof.

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

10. A method of using a control solution and preparing for testing using the same, the method comprising:

providing a control solution, the control solution including a control marker and a predetermined amount of analyte, the control marker being selected from the group consisting of 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), and salts thereof;

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

introducing the control solution including the control marker and the predetermined amount of analyte to the electrochemical test sensor.

11. The method of claim 10 wherein the analyte is glucose.

12. The method of claim 10 wherein the control marker is 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid or salts thereof.

13. The method of claim 10 wherein the control marker is N-acetyl-5-aminosalicyclic acid or salts thereof.

14. The method of claim 10 wherein the control marker is N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS) or salts thereof.

15. The method of claim 10 wherein the control marker is 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOOS) or salts thereof.

16. The method of claim 10 wherein the control marker is 8-anilino-1-naphthalenesulfonic acid or salts thereof.

17. The method of claim 10 wherein the control marker is 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate or salts thereof.

18. The method of claim 10 wherein the control marker is sodium diphenylamine-4-sulfonate or salts thereof.

19. The method of claim 10 wherein the control marker is N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS) or salts thereof.