Detecting incomplete fill of biosensors

• US 7,945,394 B2
• Filed: 06/16/2005
• Issued: 05/17/2011
• Est. Priority Date: 06/17/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brown, Daniel V., Blaschke, Christina
• Primary Examiner(s): Lau; Tung S
• Application Number:
  US11/597,579
• Publication Number:
  US 20080033667A1
• Time in Patent Office: 2,161 Days
• Field of Search: 702/23
• US Class Current: 702/23
• 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 detecting incomplete filling of an electrochemical biosensor by collecting a series of electrical current values when a constant electrical potential is applied across the working and counter electrodes during a preliminary burn period. The slope of a line determined by linear regression based on the series of current values is used to determine whether or not the biosensor is incompletely filled. If the line has a positive slope, the biosensor is reported to be under filled. If the slope is not positive, the correlation coefficient of the current values is used as a supplemental test to indicate whether or not the biosensor is incompletely filled.

Claims

1. A method of detecting an incomplete filling of a liquid sample in an electrochemical biosensor having working and counter electrodes, the method comprising the acts of:

(a) applying a constant electrical potential across said working and counter electrodes for a predetermined period of time;

(b) measuring the current passing between said working and counter electrodes;

(c) collecting values of the current measured in act (b) at predetermined times during said predetermined period of time of act (a);

(d) determining by linear regression the slope of a line defined by the values of current collected in act (c); and

(e) reporting as incompletely filled a biosensor exhibiting a positive slope of a line as determined in act (d).

2. The method of claim 1 further comprising the acts of:

(f) determining the correlation coefficient of the collected data of act (c);

(g) reporting as an incompletely filled a biosensor exhibiting a negative slope of a line as determined in act (d) and when the correlation coefficient determined in act (f) is less than a predetermined value.

3. The method of claim 2 wherein said predetermined value is from about 0.80 to about 0.95.

4. The method of claim 3 wherein said predetermined value is about 0.95.

5. The method of claim 1 wherein said collected values are obtained during the second half of said predetermined period of act (a).

6. The method of claim 1 wherein said collected values of act (c) are at least 5 in number.

7. The method of claim 6 wherein said collected values are at least 6 in number.

8. The method of claim 1 wherein said predetermined period of time of act (a) is from about 2 to about 10 seconds.

9. The method of claim 8 wherein said predetermined period of time of act (a) is 10 seconds.

10. The method of claim 1 wherein said biosensor measures the glucose concentration of whole blood.

11. A method of determining of an analyte concentration of a fluid sample, the method comprising the acts of:

providing said fluid sample;

providing an electrochemical biosensor including a working electrode, a counter electrode, and a reagent;

placing said fluid sample into contact with said reagent;

applying an electrical potential across said working and counter electrodes for a predetermined period of time;

measuring the current passing between said working and counter electrodes;

collecting values of the measured current at predetermined times during said predetermined period of time;

determining by statistical methods the slope of a line defined by the collected current values;

reporting a biosensor as being as incompletely filled if said biosensor exhibits a positive slope of said line defined by the collected current values; and

if said biosensor is not incompletely filled, determining the analyte concentration of said fluid sample.

12. The method of claim 11 wherein the statistical method is linear regression.

13. The method of claim 12 further comprising the acts of:

determining the correlation coefficient of the collected values of the measured current;

reporting a biosensor as being incompletely filled if said biosensor exhibits a negative slope of a line and the correlation coefficient is less than a predetermined value.

14. The method of claim 13 wherein said predetermined value is from about 0.80 to about 0.95.

15. The method of claim 11 wherein said collected values are obtained during the second half of said predetermined period.

16. The method of claim 11 wherein said predetermined period of time is from about 2 to about 10 seconds.

17. The method of claim 11 wherein said fluid sample is blood.

18. The method of claim 11 wherein said analyte is glucose.

19. A method of determining of an analyte concentration of a fluid sample, the method comprising the acts of:

providing said fluid sample;

providing an electrochemical biosensor including a first electrode, a second electrode, and a reagent;

placing said fluid sample into contact with said reagent;

applying a electrical potential across said first and second electrodes for a predetermined period of time;

measuring the current passing between said first and second electrodes;

collecting values of the measured current at predetermined times during said predetermined period of time;

determining the slope of a line defined by the collected current values;

reporting a biosensor as being as incompletely filled if said biosensor exhibits a positive slope of said line defined by the collected current values; and

if said biosensor is not incompletely filled, determining the analyte concentration of said fluid sample.

20. The method of claim 19 further comprising the acts of:

determining the correlation coefficient of the collected values of the measured current;

reporting a biosensor as being incompletely filled if said biosensor exhibits a negative slope of a line and the correlation coefficient is less than a predetermined value.

21. The method of claim 19 wherein the applied electrical potential is constant.