System and method for determining an abused sensor during analyte measurement

• US 8,377,707 B2
• Filed: 07/17/2009
• Issued: 02/19/2013
• Est. Priority Date: 06/20/2003
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Burke, David W., Kuhn, Lance S., Maxwell, James
• Primary Examiner(s): Soderquist, Arlen
• Application Number:
  US12/505,124
• Publication Number:
  US 20090292489A1
• Time in Patent Office: 1,313 Days
• Field of Search: 204/196.03, 204/401, 204/196.02, 205/775, 205/792, 324/525, 324/600, 422 55- 58, 422 8201- 8204, 422/425, 436/43, 436/46, 436/68, 436 93- 95, 436/131, 436149-151, 436/183, 702/19, 702 22- 23, 702/25
• US Class Current: 436/150
• CPC Class Codes: G01N 27/02 by investigating impedance
• CPC Class Codes: G01N 27/121 for determining moisture content, e.g. humidity, of the fluid moisture content of the tested material G01N27/048
• 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: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]
• CPC Class Codes: Y10T 436/143333 Saccharide [e.g., DNA, etc.]
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A method of measuring an analyte in a biological fluid comprises applying an excitation signal having a DC component and an AC component. The AC and DC responses are measured; a corrected DC response is determined using the AC response; and a concentration of the analyte is determined based upon the corrected DC response. Other methods and devices are disclosed.

Claims

1. A method of detecting whether a disposable, dry reagent, electrochemical test strip is unsuitable for use in testing for analyte in a fluid sample, comprising:

applying a signal to the test strip before dosing the test strip, the test strip including a pair of measurement electrodes and a dry reagent, the signal comprising multiple frequencies and being applied between the measurement electrodes of the test strip;

calculating an impedance value between the electrodes;

comparing the impedance value against a threshold; and

performing one action if the comparison indicates that the test strip is unsuitable for use in testing for analyte, and performing a different action if the comparison does not indicate that the test strip is unsuitable for use in testing for analyte.

2. The method of claim 1, wherein the method is automatically performed at a predetermined time.

3. The method of claim 1, wherein the method includes applying a combination of a DC bias and an AC voltage of multiple frequencies.

4. The method of claim 1, wherein the signal comprises a square wave.

5. The method of claim 1 in which said comparing comprises determining if the impedance value is characteristic of a test strip having a level of current leakage prior to dosing which indicates that the test strip is not suitable for testing for analyte.

6. The method of claim 5 in which said comparing comprises determining if the impedance value is characteristic of a test strip which has been exposed to an excessive amount of water.

7. A program for detecting whether a disposable, dry reagent, electrochemical test strip is unsuitable for use in testing for analyte in a fluid sample, comprising a computer usable media including at least one computer program embedded therein that is capable of causing at least one computer to perform:

applying a signal to the test strip before dosing the test strip, the test strip including a pair of measurement electrodes and a dry reagent, the signal comprising multiple frequencies and being applied between the measurement electrodes of the test strip;

calculating an impedance value;

comparing the impedance value against a threshold; and

performing one action if the comparison indicates the test strip is unsuitable for use in testing for analyte, and performing a different action if the comparison does not indicate that the test strip is unsuitable for use in testing for analyte.

8. The program of claim 7, wherein the method is automatically performed at a predetermined time.

9. The program of claim 7, wherein the applying a signal step includes applying a combination of a DC bias and an AC voltage of multiple frequencies.

10. The program of claim 7, wherein the signal comprises a square wave.

11. A method for determining if a disposable, dry reagent, electrochemical test strip adapted for determining a concentration of a medically significant component of a biological fluid is unsuitable for use in testing for the component, comprising the steps of:

a) applying a signal to the test strip before dosing the test strip, the test strip including a pair of measurement electrodes and a dry reagent, the signal comprising multiple frequencies and being applied between the measurement electrodes of the test strip;

b) measuring a response to the signal; and

c) using the response to determine if the test strip is unsuitable for use in testing for the component.

12. The method of claim 11 in which step c) comprises determining if the test strip has a level of current leakage prior to dosing which indicates that the test strip is not suitable for testing for the component.

13. The method of claim 12 in which step c) comprises determining if the level of current leakage is characteristic of a test strip which has been exposed to an excessive amount of water.