Methods of using an electrochemical biosensor

• US 8,137,529 B2
• Filed: 11/18/2010
• Issued: 03/20/2012
• Est. Priority Date: 02/06/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Huang, Dijia, Charlton, Steven C., George, Suny J., Edelbrock, Andrew J.
• Primary Examiner(s): Barton, Jeffrey T
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US12/949,645
• Publication Number:
  US 20110061458A1
• Time in Patent Office: 488 Days
• Field of Search: 204/401, 2044031-40314, 204/409, 204/406.06, 204/412, 204/411, 204416-418, 205/775, 205/778, 205/792, 205/789, 205/775.5, 205/777.5, 205/787, 205/779, 324662-664, 731/49, 702/23
• US Class Current: 205/777.5
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• 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 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: Y10T 29/49082 Resistor making
• CPC Class Codes: Y10T 29/49099 Coating resistive material on a base

Abstract

According to one embodiment of the present invention, an electrochemical sensor (10) for detecting the concentration of analyte in a fluid test sample is disclosed. The sensor (10) includes a counter electrode having a high-resistance portion for use in detecting whether a predetermined amount of sample has been received by the test sensor.

Claims

1. A method for evaluating whether an electrochemical sensor is properly filled, the electrochemical sensor including a working electrode and a counter electrode, the counter electrode including a high-resistance portion and a low-resistance portion, the high-resistance portion including a resistor, the method comprising:

introducing the fluid test sample to the electrochemical test sensor;

applying a first potential between a counter electrode and a working electrode for a first predetermined time period after the fluid test sample has electrically connected the working electrode and the counter electrode;

after the first predetermined time period, applying a second potential between the counter electrode and the working electrode for a second predetermined time period, the second potential having a magnitude that is greater than a magnitude of the first potential;

measuring the current between the counter electrode and the working electrode at a first interval during the first predetermined time period to obtain a first current measurement;

measuring the current between the counter electrode and the working electrode at a second interval during the second predetermined period to obtain a second current measurement;

determining a first parameter based on the first current measurement and the second current measurement;

comparing the first parameter to at least one first predetermined parameter; and

notifying a user that an insufficient quantity of fluid test sample has been introduced to the electrochemical test sensor based on the comparing the first parameter to the at least one first predetermined parameter.

2. The method of claim 1, wherein the first parameter is determinable by a calculation having the general form

first parameter=ln(I_t1)−

ln(t₂)/(ln(t2)−

ln(t1))

where I_t1 is the first current measurement at the first interval, t1, and I_t2 is the second current measurement at the second interval, t2.

3. The method of claim 1, wherein the second current measurement has a magnitude that is greater than a magnitude of the first current measurement when an insufficient quantity of fluid test sample has been introduced to the electrochemical test sensor.

4. The method of claim 1, further comprising:

after the second time period, applying a third potential between the counter electrode and the working electrode for a third predetermined time period;

measuring the current between the counter electrode and the working electrode at a third interval during the third predetermined time period to obtain a third current measurement;

measuring the current between the counter electrode and the working electrode at a fourth interval during the third predetermined time period to obtain a fourth current measurement;

determining a second parameter based on the third current measurement and the fourth current measurement;

comparing a second parameter to at least one second predetermined parameter; and

notifying a user that an insufficient quantity of fluid test sample has been introduced to the electrochemical test sensor based on the comparing the second parameter to the at least one second predetermined parameter.

5. The method of claim 4, wherein the second parameter is determinable by a calculation having the general form

second parameter=ln(I_t3)−

ln(I_t4)/(ln(t4)−

ln(t3))

where I_t3 is the third current measurement at the third interval, t3, and I_t4 is the fourth current measurement at the fourth interval, t4.

6. The method of claim 4, wherein the first predetermined time period and the second predetermined time period comprise a burn period, the third predetermined time period comprises a read period, and no potential is applied between the counter electrode and the working electrode for a wait period, the wait period being after the burn period and prior to the read period.

7. The method of claim 4, wherein the first predetermined time period and the second predetermined time period comprise a first pulse period, and the third predetermined time period comprises a second pulse period.

8. A method for evaluating whether an electrochemical test sensor is properly filled, the test sensor including a working electrode electrically coupled to a first lead and a counter electrode electrically coupled to a second lead, the counter electrode including a low-resistance portion and a high-resistance portion, the high-resistance portion including a resistor, the method comprising:

applying a voltage profile across the first and second leads;

measuring the current profile at the first and second leads in response to the applied voltage profile;

comparing the measured current profile to a predetermined current profile; and

generating an under-filled error signal based on the comparing of the measured current profile to the predetermined profile.

9. The method of claim 8 wherein the predetermined profile is a decay-shaped profile.

10. The method of claim 8 comprising forming an electrical communication between only the high-resistance portion of the counter electrode and the working electrode when the test sensor is under-filled.

11. The method of claim 8 comprising forming an electrical communication between the low-resistance and high-resistance portions of the counter electrode and the working electrode when the test sensor is appropriately-filled.

12. The method of claim 8 wherein the fluid test sample comprises blood.

13. The method of claim 8 wherein the analyte comprises glucose.

14. A method for evaluating whether an electrochemical sensor is properly filled, the test sensor including a working electrode coupled to a first lead, and counter electrode coupled to a second lead, the counter electrode including a high-resistance portion and a low-resistance portion, the high-resistance portion including a resistor, the test sensor including a reagent disposed on the working electrode that is adapted to react with glucose in a blood sample for producing an electrochemical reaction indicative of the concentration of the glucose in the blood sample, the method comprising:

collecting a blood sample;

applying a voltage profile across the first and second leads;

measuring the current profile at the first and second leads in response to the applied voltage profile; and

generating an under-filled error signal when the measured current profile is not of a predetermined shape.

15. The method of claim 14 wherein the predetermined shape is a decay-shaped.

16. The method of claim 14 comprising forming an electrical communication between only the high-resistance portion of the counter electrode and the working electrode when the test sensor is under-filled.

17. The method of claim 14 comprising forming an electrical communication between the low-resistance portion of the counter electrode and the working electrode when the test sensor is appropriately-filled.

18. The method of claim 14 wherein the reagent comprises glucose oxidase.

19. The method of claim 14 wherein the reagent is also disposed on the low-resistance portion of the counter electrode.

20. The method of claim 14, wherein the resistor is screen printed on an insulating base of the test sensor.

21. The method of claim 14, wherein the reagent is also disposed on the high-resistance portion.

22. The method of claim 14, wherein the test sensor includes a flow path for receiving the blood sample, the low-resistance portion of the counter electrode is disposed along the flow path downstream from the working electrode, and the high-resistance portion of the counter electrode is disposed along the flow path upstream from the working electrode.

23. A method for evaluating whether an electrochemical sensor is properly filled, the test sensor including a working electrode coupled to a first lead, and counter electrode coupled to a second lead, the counter electrode including a high-resistance portion and a low-resistance portion, the high-resistance portion including a resistor, the method comprising:

collecting a blood sample;

applying a first potential across the first and second leads for a first predetermined time period;

after the first predetermined time period, applying a second potential across the first and second leads for a second predetermined time period, the second potential having a magnitude that is greater than a magnitude of the first potential; and

measuring the current at the first and second leads at least one interval in response to the applied first potential and the applied second potential.

24. The method of claim 23, further comprising generating an under-filled error signal based on the measured current.