Method of using an electrochemical test sensor

• US 10,690,614 B2
• Filed: 02/23/2018
• Issued: 06/23/2020
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Lin, Jing, Tsai, Fu Hsiung, Wu, Huan-Ping, Ellis, Nicole D., Arndt, Henry C.
• Primary Examiner(s): Kaur, Gurpreet
• Application Number:
  US15/903,902
• Publication Number:
  US 20180180565A1
• Time in Patent Office: 851 Days
• 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 an electrochemical test sensor, the method comprising the acts of:

introducing a fluid sample to the electrochemical test sensor;

applying a first voltage to the fluid sample;

measuring a first current value of the fluid sample at the first voltage;

applying a second voltage to the fluid sample;

measuring a second current value of the fluid sample at the second voltage;

comparing the first current value to a number so as to determine if the fluid sample is an analyte-fluid test sample; and

if the comparison using the first current value does not result in determining whether the sample is an analyte-fluid test sample, then using at least the first current value at the first voltage and the second current value at the second voltage to determine whether a control solution or the analyte-fluid test sample is present,

wherein the first voltage is higher than the second voltage.

2. The method of claim 1, wherein the comparing the first current value to a number so as to determine if the sample is an analyte-fluid test sample includes determining whether the first current value is less than the number and, if so, then determining that the sample is an analyte-fluid test sample.

3. The method of claim 1, wherein determining whether a control solution or a fluid sample is present includes using a ratio of the first current value and the second current value.

4. The method of claim 3, wherein the ratio is 1.3 or greater.

5. The method of claim 4, wherein the ratio is 1.5 or greater.

6. The method of claim 5, wherein the ratio is 1.75 or greater.

7. The method of claim 1, wherein the analyte-fluid test sample is a whole blood sample.

8. A method of using an electrochemical test sensor the method comprising the acts of:

providing an electrochemical test sensor including a working electrode, a counter electrode and a reagent, the reagent being selected from glucose oxidase or glucose dehydrogenase;

introducing a fluid sample to the electrochemical test sensor;

applying a first voltage to the fluid sample;

measuring a first current value of the fluid sample at the first voltage;

applying a second voltage to the fluid sample;

measuring a second current value of the fluid sample at the second voltage;

comparing the first current value to a number so as to determine if the fluid sample is an analyte-fluid test sample; and

if the comparison using the first current value does not result in determining whether the sample is an analyte-fluid test sample, then using at least the first current value at the first voltage and the second current value at the second voltage to determine whether a control solution or the analyte-fluid test sample is present,

wherein the first voltage is higher than the second voltage.

9. The method of claim 8, wherein the comparing the first current value to a number so as to determine if the sample is an analyte-fluid test sample includes determining whether the first current value is less than the number and, if so, then determining that the sample is an analyte-fluid test sample.

10. The method of claim 8, wherein determining whether a control solution or a fluid sample is present includes using a ratio of the first current value and the second current value.

11. The method of claim 10, wherein the ratio is 1.3 or greater.

12. The method of claim 11, wherein the ratio is 1.5 or greater.

13. The method of claim 12, wherein the ratio is 1.75 or greater.

14. The method of claim 8, wherein the analyte-fluid test sample is a whole blood sample.

15. The method of claim 8, wherein the reagent is glucose oxidase.

16. The method of claim 8, wherein the reagent is glucose dehydrogenase.