Systems, devices, and methods for improving accuracy of biosensors using fill time

• US 8,101,065 B2
• Filed: 12/30/2009
• Issued: 01/24/2012
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Primary Examiner(s): Olsen, Kaj K
• Application Number:
  US12/649,594
• Publication Number:
  US 20110155585A1
• Time in Patent Office: 755 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.04, 205/777.5, 205/792
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/006 for glucose
• 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 27/416 Systems G01N27/27 takes precedence

Abstract

Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, a sample including an analyte is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and a fill time of the sample into the device is calculated. A concentration of the analyte in view of fill time can then be determined. Systems and devices that take advantage of the fill time to make analyte concentration determinations are also provided.

Claims

1. A method for determining a concentration of an analyte in a sample, the method comprising:

introducing a sample including an analyte into an electrochemical cell of a sample analyzing device, the electrochemical cell having a working electrode and a counter electrode;

determining a fill time of the sample;

calculating a prepulse time in view of at least the fill time;

applying an electric potential between the working electrode and the counter electrode for a length of time equal to the prepulse time; and

determining a concentration of the analyte.

2. The method of claim 1, wherein determining a fill time of the sample comprises:

applying an electric potential between the working electrode and the counter electrode as the sample is introduced;

measuring cell current as a function of time; and

determining a current drop time based on cell current as a function of time, wherein the current drop time corresponds to the fill time of the sample.

3. The method of claim 2, wherein determining a current drop time is achieved by calculating the maximum negative value of the change in measured cell current over time.

4. The method of claim 2, wherein measuring cell current as a function of time comprises:

performing current measurements approximately every 2 milliseconds; and

calculating and storing an average current based on the current measurements

approximately every 10 milliseconds.

5. The method of claim 1, further comprising:

determining a level of haematocrit in the sample in view of the fill time of the sample.

6. The method of claim 5, wherein determining a concentration of the analyte comprises calculating the concentration of the analyte in view of the determined level of haematocrit.

7. The method of claim 1, wherein the sample analyzing device comprises a glucose sensor.

8. The method of claim 1, wherein the sample analyzing device comprises an immunosensor.

9. The method of claim 1, wherein the sample comprises blood.

10. The method of claim 9, wherein the blood comprises whole blood.