Method of using an electrochemical test sensor

• US 9,933,385 B2
• Filed: 09/19/2014
• Issued: 04/03/2018
• 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:
  US14/491,272
• Publication Number:
  US 20150008143A1
• Time in Patent Office: 1,292 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 pulse sequence to the fluid sample, the pulse sequence comprising at least two duty cycles within 180 seconds, at least one of the duty cycles having a first potential in a first excitation period and a first relaxation period, and after one of the duty cycles, providing a second potential to the sample, the second potential being greater than the first potential, the second potential being supplied after a second relaxation period, the second relaxation period being less than the first relaxation period;

measuring a first current at the first potential responsive to an analyte;

measuring a second current at the second potential responsive to the analyte; and

determining whether the fluid sample is a control solution or an analyte-fluid test sample based on the measured first and second currents.

2. The method of claim 1 wherein at least one of the first and second relaxation periods uses an open circuit.

3. The method of claim 2 wherein the first and second relaxation periods use an open circuit.

4. The method of claim 1 wherein each of the duty cycles uses the first potential.

5. The method of claim 1 wherein the at least two duty cycles are from 3 to 18 duty cycles.

6. The method of claim 5 wherein the at least two duty cycles are from 3 to 10 duty cycles.

7. The method of claim 6 wherein the at least two duty cycles are performed in 30 seconds or less.

8. The method of claim 1 wherein the at least two duty cycles are 3 to 8 duty cycles and are performed in 3 to 16 seconds.