Underfill recognition biosensor

• US 9,234,866 B2
• Filed: 01/21/2014
• Issued: 01/12/2016
• Est. Priority Date: 11/10/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wu, Huan-Ping, Perry, Joseph E., Trippel, Christine, Maurer, Eric
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US14/159,901
• Publication Number:
  US 20140216930A1
• Time in Patent Office: 721 Days
• US Class Current: 1/1
• 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 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence

Abstract

A biosensor with an underfill recognition system assesses whether to analyze a sample for one or more analytes in response to the volume of the sample. The underfill recognition system applies polling and test excitation signals to the sample. The polling signals generate one or more polling output signals, which maybe used to detect when a sample is present and to determine whether the sample has sufficient volume for analysis. The test excitation signal generates one or more test output signals, which may be used to determine one or more analyte concentrations in the sample.

Claims

1. A biosensor with an underfill recognition system, comprising:

a sensor strip having a sample interface on a base, where the sample interface is in electrical communication with a working electrode and a counter electrode, the working and counter electrodes positioned in a reservoir formed by the base; and

a measuring device having a sensor interface with a signal generator, and where the sensor interface has electrical communication with the sample interface; and

a processor connected to the sensor interface and programmed to;

direct the signal generator to apply a regular polling sequence to a sample contacting the working electrode and the counter electrode, the regular polling sequence substantially eliminating irreversible alteration of the concentration of at least one analyte in the sample during the application of the regular polling sequence,

detect the presence of the sample,

direct the signal generator to apply an extended polling sequence to the sample, the extended polling sequence having at least one different extended input pulse, and the extended polling sequence substantially eliminating irreversible alteration of the concentration of the at least one analyte in the sample during the application of the extended polling sequence,

detect whether a sample volume is sufficient for analysis of at least one analyte in the sample,

direct the signal generator to apply a test excitation signal to the sample when the sample volume is sufficient for the analysis of the at least one analyte in the sample, and where the test excitation signal irreversibly alters the concentration of the at least one analyte in the sample during the application of the test excitation signal, and

determine a concentration of the at least one analyte in the sample in response to a test output signal generated from the test excitation signal.

2. The biosensor of claim 1, further comprising:

comparator circuitry connected to the processor and the sensor interface, the comparator circuitry programmed to;

detect when at least one regular output pulse reaches at least one sample threshold, and

detect when at least one different extended output pulse reaches at least one volume threshold.

3. The biosensor of claim 1, where the processor is further programmed to direct the signal generator to apply a test excitation signal having at least one test input pulse with a test amplitude that is essentially the same as a regular amplitude of at least one regular input pulse of the regular polling sequence.

4. The biosensor of claim 1, where the processor is further programmed to detect at least one of a selected volume and a range of volumes.

5. The biosensor of claim 1, where a last pulse in the extended polling sequence is the at least one different extended input pulse.

6. The biosensor of claim 1,

where the extended polling sequence has at least one similar extended input pulse in addition to the at least one different extended input pulse,

where the at least one similar extended input pulse has an extended amplitude that is essentially the same as a regular amplitude of at least one regular input pulse of the regular polling sequence, and

where the at least one different extended pulse has another extended amplitude that is not the same as the regular amplitude of the at least one regular input pulse.

7. The biosensor of claim 1, where the extended polling sequence has at least one cycle, where the at least one cycle has at least one similar extended input pulse and at least one different extended input pulse.

8. The biosensor of claim 7,

where the at least one similar extended input pulse has an extended amplitude that is essentially the same as a regular amplitude of at least one regular input pulse of the regular polling sequence, and

where the at least one different extended pulse has another extended amplitude that is not the same as the regular amplitude of the at least one regular input pulse.

9. The biosensor of claim 8, where a last pulse in the at least one cycle is the at least one different extended input pulse.

10. The biosensor of claim 1, where the processor is further programmed to:

count a delay period when the sample volume is insufficient for the analysis; and

detect whether the sample volume is sufficient for the analysis of the at least one analyte in the sample after the delay period.

11. The biosensor of claim 1, further comprising a display connected to the processor, the processor being further programmed to:

show an error signal on the display in response to an underfill condition,

stop the test excitation signal,

request a user to add more sample,

direct the signal generator to apply another regular polling sequence,

detect when at least one regular output pulse reaches at least one sample threshold,

direct the signal generator to apply another extended polling sequence,

detect when at least one different extended output pulse reaches at least one volume threshold, and

direct the signal generator to apply the test excitation signal when the sample volume is sufficient for the analysis of the at least one analyte in the sample.

12. The biosensor of claim 1, where the sample interface includes the working electrode, the counter electrode, and at least one mediator.

13. The biosensor of claim 1, where the counter and the working electrodes include a redox couple.

14. The biosensor of claim 1, where the counter electrode has a sub-element.

15. The biosensor of claim 14, further comprising a mediator disposed between the counter electrode and the working electrode, where the mediator is not substantially disposed between the working electrode and the sub-element.

16. The biosensor of claim 15, where the mediator includes a two electron transfer mediator.

17. The biosensor of claim 15, where the regular polling sequence, the extended polling sequence, and the test excitation signal are part of an electrochemical sensor analysis.