METHOD FOR AUTOMATICALLY AND RAPIDLY DISTINGUISHING BETWEEN CONTROL AND SAMPLE SOLUTIONS IN A BIOSENSOR STRIP

• US 20120132540A1
• Filed: 01/31/2008
• Published: 05/31/2012
• Est. Priority Date: 01/31/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Feldman, Benjamin J.
• Granted Patent: US 8,431,011 B2
• Time in Patent Office: Days
• US Class Current: 205/775
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• 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
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

The present invention is directed to electrochemical sensors and systems and methods for electrochemically sensing a particular constituent within a fluid through the use of a diagnostic test. The methods provide for automatic discrimination of sample from control or standard solutions. A device and system used to determine a constituent level within a fluid that employ such automatic sample discrimination methods or specially formulated solutions is also provided.

Claims

1. Use of an electrochemical biosensor having two or more electrodes for the measurement of one or more analytes in a fluid, comprising:

introducing a biological fluid sample or control solution into an electrochemical biosensor;

applying a first voltage and obtaining one measurement;

applying a second voltage and obtaining a second measurement;

wherein one measurement measures an analyte-dependent signal and the other measurement measures a control solution-dependent signal;

obtaining a reading of the fluid conductivity; and

calculating the current to determine whether the fluid is a biological fluid sample or a control solution.

2. The use claim 1 wherein the first voltage applied precedes measurement of an analyte and the second voltage applied precedes measurement of the conductivity of the solution.

3. The use of claim 1 wherein the second voltage applied is greater than the first voltage applied.

4. The use of claim 1 wherein the second voltage applied is at least 50 mV.

5. The use of claim 1 wherein the second voltage applied is at least 400 mV.

6. The use of claim 1 wherein the voltage applied preceding the measurement of the analyte is applied across a different pair of electrodes than the voltage applied preceding the measurement of the conductivity of the solution.

7. The use of claim 1 wherein the voltage applied preceding the measurement of the analyte is applied across a working electrode and a non-working electrode.

8. The use of claim 1 wherein the voltage applied preceding the measurement of the conductivity of the solution is applied across two non-working electrodes.

36. A control solution for use in the method of claim 1, wherein said control solution has a substantially different ionic strength than that in a sample solution.

37. The control solution of claim 36 wherein the ionic strength is at least about 200 mM, 400 mM, or 600 mM.

38. The control solution of claim 36 wherein addition of a chloride salt is used to increase the ionic strength.

39. The control solution of claim 38 wherein the chloride salt is sodium chloride.

9. A method for automatically discriminating a sample solution from control solution, comprising:

introducing a sample or control solution into an electrochemical biosensor, said biosensor comprising one or more non-working electrodes or traces, at least one working electrode, and at least one enzyme reagent;

applying a voltage between any pair of electrodes;

measuring the current; and

automatically identifying the sample or control solutions based on the current value.

10. The method of claim 9 wherein the enzyme reagent is deposited onto the working electrode.

11. The method of claim 9 wherein the voltage is applied by a measurement device such as a meter receiving port.

12. The method of claim 9 wherein the current is measured by a measurement device such as such as a meter receiving port.

13. The method of claim 9 wherein an identifying device automatically identifies the sample or control solutions based on the current value.

14. The method of claim 9 wherein the voltage applied is at least 50 mV.

15. The method of claim 9 wherein the voltage applied is at least 400 mV.

16. The method of claim 9 wherein said non-working electrodes or traces include at least one of a reference, counter, indicator, trigger, and dummy

17. The method of claim 9, wherein said non-working electrodes or traces comprise a conductive metal.

18. The method of claim 9, wherein said non-working electrodes or traces comprise Ag/AgCl.

19. The method of claim 9, wherein said current is temperature dependent and a measured temperature value is used in the step of said identifying the sample or control solution.

20. The method of claim 9, wherein said working electrode is disconnected during the step of measuring said current.

21. The method of claim 9, wherein the step of automatically discriminating a sample solution from control solution is initiated before or after an analyte determination.

22. The method of claim 13, wherein the measurement device measures the concentration of an analyte in a sample solution.

23. The method of claim 22, wherein the sample solution comprises an electrochemically active agent.

24. The method of claim 23, wherein the electrochemically active agent is selected from the group consisting of glucose and ketones.

34. A control solution for use in the method of claim 9, wherein said control solution has a substantially different conductivity than that in a sample solution.

35. The control solution of claim 34, wherein the conductivity is substantially higher than that in the sample solution.

25. A device for determining the concentration of a component of a biological fluid, wherein said device automatically discriminates a sample solution from a control solution without the need for human intervention, wherein said device comprises the following:

at least two non-working electrodes or traces;

at least one working electrode;

a reagent;

a mechanism for applying a voltage between at least 2 non-working electrodes or traces;

a mechanism for measuring the current; and

a mechanism for automatically identifying the sample or control solutions based on the current value.

26. The device of claim 25, wherein said non-working electrodes or traces include at least one of a reference, counter, indicator, trigger, and dummy

27. The device of claim 25, wherein said non-working electrodes or traces comprise Ag/AgCl.

28. The device of claim 25, wherein said device includes a mechanism for measuring temperature.

29. The device of claim 25, wherein said working electrode is disconnected during the step of measuring said current.

30. The device of claim 25, wherein the device is capable of measuring the analyte concentration of a species selected from the group consisting glucose and ketones.

31. A system for measuring medically significant constituents of a biological fluid,

wherein the system automatically discriminates a sample solution from a control solution without the need for human intervention, comprising:

at least two non-working electrodes or traces;

at least one working electrode;

a reagent;

a mechanism for applying a voltage between at least 2 non-working electrodes or traces;

a mechanism for measuring the current;

a mechanism for automatically identifying the sample or control solutions based on the current value;

a mechanism for recording, displaying or transmitting results that include the determination of sample or control.

32. The system of claim 31 wherein said system includes a mechanism for measuring temperature.

33. The system of claim 31 wherein said system includes a mechanism for wirelessly transmitting the determination of sample or control.