System and method for analyte measurement employing maximum dosing time delay

• US 7,597,793 B2
• Filed: 10/17/2003
• Issued: 10/06/2009
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Burke, David W., Kuhn, Lance S.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/687,850
• Publication Number:
  US 20040259180A1
• Time in Patent Office: 2,181 Days
• Field of Search: 205/777.5, 205/792, 205/787, 205/789, 205/775, 204/400, 204/403, 204/416, 204/417, 204/418, 204/433
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

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 performing a measurement on a biological fluid in a test strip comprising:

providing a biological fluid test strip including

a capillary fill chamber extending a length along the test strip from an intake opening to a terminus,

a first pair of electrodes in operative communication with the chamber, and

a second pair of electrodes in operative communication with the chamber;

dosing the test strip with a biological fluid effective to cause the biological fluid to flow from the intake opening toward the terminus;

applying a first test signal to at least one of the first pair of electrodes;

measuring a first response to the first test signal;

maintaining the first pair of electrodes in an inoperative state after the measuring the first response;

applying a second test signal to at least one of the second pair of electrodes, wherein the second test signal is a signal having an AC component;

measuring a second response to the second test signal to determine sample sufficiency of the dose of the biological fluid; and

performing a measurement upon the biological fluid after the measuring the second response.

2. The method of claim 1 wherein the measuring the first response to the first test signal is effective to indicate a contact of the first pair of electrodes and the biological fluid.

3. The method of claim 1 wherein the measuring the second response to the second test signal is effective to indicate a contact of the second pair of electrodes and the biological fluid.

4. The method of claim 1 wherein the measuring the first response to the first test signal is effective to indicate a contact of the first pair of electrodes and the biological fluid and the measuring the second response to the second test signal is effective to indicate a contact of the second pair of electrodes and the biological fluid.

5. The method of claim 1 wherein the performing a measurement upon the biological fluid includes applying a measurement test signal to at least one of the first pair of electrodes.

6. The method of claim 1 further comprising providing a third pair of electrodes in operative communication with the chamber wherein the performing a measurement upon the biological fluid includes applying a measurement test signal to at least one of the third pair of electrodes.

7. The method of claim 1 wherein the second test signal is an AC signal.

8. A method of indicating acceptable fill time of a biological fluid in a test strip comprising:

providing a biological fluid test strip including

a capillary fill chamber extending a length along the test strip from an intake opening to a terminus,

a first pair of electrodes in operative communication with the chamber,

a second pair of electrodes in operative communication with the chamber; and

a third pair of electrodes in operative communication with the chamber;

dosing the test strip with a biological fluid effective to cause the biological fluid to flow from the intake opening toward the terminus;

flowing a biological fluid from the opening toward the terminus;

first determining when the biological fluid contacts the first pair of electrodes;

second determining when the biological fluid contacts the second pair of electrodes;

determining a fill time value based upon the first determining and the second determining;

comparing the fill time value to a predetermined value; and

third measuring a first analyte concentration of the biological fluid using the third pair of electrodes;

wherein the first pair of electrodes and the second pair of electrodes are not used to measure the first analyte concentration or any second analyte concentration.

9. The method of claim 8 further comprising:

indicating an error condition if the fill time value exceeds the predetermined value.

10. The method of claim 8 further comprising:

indicating an error condition if the fill time value is greater than or equal to the predetermined value.

11. The method of claim 8 further comprising:

performing a measurement upon the biological fluid if the fill time value is less than the predetermined value.

12. The method of claim 8 further comprising:

performing a measurement upon the biological fluid if the fill time value is less than or equal to the predetermined value.

13. A method of performing a measurement on a biological fluid in a test strip comprising:

providing a biological fluid test strip including

a capillary fill chamber extending a length along the test strip from an intake opening to a terminus,

a first pair of electrodes in operative communication with the chamber;

a second pair of electrodes in operative communication with the chamber; and

a third pair of electrodes in operative communication with the chamber;

dosing the test strip with a biological fluid effective to cause the biological fluid to flow from the intake opening toward the terminus;

applying a first test signal to at least one of the first pair of electrodes;

measuring a first response to the first test signal;

maintaining the first pair of electrodes in an inoperative state after the measuring the first response;

applying a second test signal to at least one of the second pair of electrodes;

measuring a second response to the second test signal;

determining a fill time of the chamber based upon the first response and the second response;

applying a measurement test signal to at least one of the third pair of electrodes after the measuring the second response;

measuring a third response to the third test signal; and

determining a first concentration of an analyte in the biological fluid using the third response;

wherein the first pair of electrodes and the second pair of electrodes are not used to measure the first analyte concentration or any second analyte concentration.

14. The method of claim 13 wherein the measuring the first response to the first test signal is effective to indicate a contact of the first pair of electrodes and the biological fluid.

15. The method of claim 13 wherein the measuring the second response to the second test signal is effective to indicate a contact of the second pair of electrodes and the biological fluid.

16. The method of claim 13 wherein the measuring the first response to the first test signal is effective to indicate a contact of the first pair of electrodes and the biological fluid and the measuring the second response to the second test signal is effective to indicate a contact of the second pair of electrodes and the biological fluid.