CONTROL SOLUTION FOR DETERMINING PERFORMANCE OF ELECTROCHEMICAL SENSING SYSTEM AND METHOD FOR THE SAME

• US 20100252453A1
• Filed: 03/31/2010
• Published: 10/07/2010
• Est. Priority Date: 04/01/2009
• Status: Abandoned Application

• Current Assignee: Apex Biotechnology Corporation
• Original Assignee: Apex Biotechnology Corporation
• Inventors: WANG, Shih-Chang, TENG, Kai-Tsung, LIN, Chien-Chuan, SHEN, Thomas Y.S., LIN, Yueh-Hui
• Application Number:
  US12/751,345
• Publication Number:
  US 20100252453A1
• Time in Patent Office: Days
• US Class Current: 205/792
• 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

A control solution for determining the performance of an electrochemical sensing system for measuring the concentration of an analyte in a body fluid sample and methods using the same are provided. The control solution contains the analyte at a predetermined amount and an alcohol-containing adjustor. The control solution generates a current signal from the electrochemical sensing system when the performance of the electrochemical sensing system is qualified and obtains a measured concentration corresponding to the current signal, wherein the measured concentration is less than the real concentration corresponding to the predetermined amount.

Claims

1. A control solution for determining the performance of an electrochemical sensing system, the electrochemical sensing system being adapted for measuring the concentration of an analyte in a body fluid sample, the control solution comprising:

the analyte at a predetermined amount; and

an alcohol-containing adjustor, wherein the control solution generates a current signal from the electrochemical sensing system when the performance of the electrochemical sensing system is qualified and obtains a measured concentration corresponding to the current signal, wherein the measured concentration is less than a real concentration corresponding to the predetermined amount.

2. The control solution according to claim 1, wherein the electrochemical sensing system is adapted for a normal control solution having the analyte but not having the alcohol-containing adjustor, and the normal control solution generates a normal current signal from the electrochemical sensing system when the performance of the electrochemical sensing system is qualified, wherein when the control solution and the normal control solution respectively contain the same predetermined amount of a contaminate, the magnitude of the current signal for the control solution is lower than the magnitude of the normal current signal for the normal control solution.

3. The control solution according to claim 1, wherein the analyte is glucose, cholesterol, lactic acid, or triglyceride.

4. The control solution according to claim 1, wherein the alcohol-containing adjustor comprises primary alcohol, secondary alcohol, or tertiary alcohol.

5. The control solution according to claim 1, wherein the alcohol-containing adjustor is ethanol.

6. The control solution according to claim 5, wherein the concentration of ethanol is ranged between 100 ml and 500 ml based on per liter of the control solution.

7. The control solution according to claim 1, wherein the alcohol-containing adjustor is glycerol.

8. The control solution according to claim 7, wherein the concentration of glycerol is ranged between 100 ml and 500 ml based on per liter of the control solution.

9. The control solution according to claim 1, wherein the alcohol-containing adjustor is polyethylene glycol.

10. The control solution according to claim 9, wherein the concentration of polyethylene glycol is ranged between 100 g and 500 g based on per liter of the control solution.

11. The control solution according to claim 1, wherein the alcohol-containing adjustor is isopropanol.

12. The control solution according to claim 11, wherein the concentration of isopropanol is ranged between 100 ml and 500 ml based on per liter of the control solution.

13. An electrochemical sensing system for measuring the concentration of an analyte in a body fluid sample, the electrochemical system comprising:

a test strip;

a measuring device; and

a control solution according to claim 1 for determining the performance of the electrochemical sensing system.

14. A method for determining the performance of an electrochemical sensing system for measuring the concentration of an analyte in a body fluid sample, the electrochemical system comprising a test strip;

a measuring device; and

a control solution having an analyte at a predetermined amount and an alcohol-containing adjustor, the method comprising;

connecting the test strip to the measuring device;

generating a current signal and a measured concentration corresponding to the current signal from the measuring device by contacting the control solution with a reaction reagent on the test strip; and

determining that the electrochemical sensing system is qualified if the measuring concentration is within a standard range for the electrochemical sensing system, or determining that the electrochemical sensing system is unqualified if the measuring concentration is out of the standard range.

15. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein when the electrochemical sensing system is determined qualified, the measuring concentration is less than a real concentration corresponding to the predetermined amount of the analyte.

16. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the electrochemical sensing system is adapted for a normal control solution having the analyte but not having the alcohol-containing adjustor, and the normal control solution generates a normal current signal from the electrochemical sensing system when the performance of the electrochemical sensing system is qualified, wherein when the control solution and the normal control solution respectively contain the same predetermined amount of a contaminate, the magnitude of the current signal for the control solution is lower than the magnitude of the normal current signal for the normal control solution.

17. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the analyte is glucose, cholesterol, lactic acid, or triglyceride.

18. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the alcohol-containing adjustor comprises primary alcohol, secondary alcohol, or tertiary alcohol.

19. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the alcohol-containing adjustor is ethanol.

20. The method for determining the performance of an electrochemical sensing system according to claim 19, wherein the concentration of ethanol is ranged between 100 ml and 500 ml based on per liter of the control solution.

21. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the alcohol-containing adjustor is glycerol.

22. The method for determining the performance of an electrochemical sensing system according to claim 21, wherein the concentration of glycerol is ranged between 100 ml and 500 ml based on per liter of the control solution.

23. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the alcohol-containing adjustor is polyethylene glycol.

24. The method for determining the performance of an electrochemical sensing system according to claim 23, wherein the concentration of polyethylene glycol is ranged between 100 g and 500 g based on per liter of the control solution.

25. The method for determining the performance of an electrochemical sensing system according to claim 14, wherein the alcohol-containing adjustor is isopropanol.

26. The method for determining the performance of an electrochemical sensing system according to claim 25, wherein the concentration of isopropanol is ranged between 100 ml and 500 ml based on per liter of the control solution.