Underfill recognition biosensor

• US 9,658,187 B2
• Filed: 12/02/2015
• Issued: 05/23/2017
• Est. Priority Date: 11/10/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Wu, Huan-Ping, Maurer, Eric, Trippel, Christine, Perry, Joseph E.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US14/957,350
• Publication Number:
  US 20160084794A1
• Time in Patent Office: 538 Days
• 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 for assessing sufficiency of a volume of a sample in the biosensor, the biosensor 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 when at least one regular output pulse reaches at least one sample threshold,

direct the signal generator to apply an extended polling sequence to the sample, 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 when at least one different extended output pulse reaches at least one volume threshold,

indicate when a sample volume is insufficient for analysis of the at least one analyte in the sample, and

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, the test excitation signal irreversibly altering the concentration of the at least one analyte in the sample during the application of the test excitation signal.

2. The biosensor of claim 1, where a last pulse in the extended polling sequence is a different extended pulse.

3. The biosensor of claim 1, where the processor is further programmed to direct the signal generator to:

apply at least one similar extended input pulse with an extended amplitude that is essentially the same as a regular amplitude of at least one regular input pulse; and

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

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

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

6. The biosensor of claim 5, 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, 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 5, where a last pulse in each cycle is a different extended pulse.

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

detect an initial extended output pulse that does not reach at least one or more volume thresholds;

count a delay period from the initial extended output pulse; and

detect a later extended output pulse after the delay period that does reach one or more volume thresholds.

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

stop the test excitation signal when the sample volume is insufficient for analysis of the at least one analyte in the sample;

request a user to add more sample;

apply another regular polling sequence to a larger sample, where the another regular polling sequence substantially eliminates irreversible alteration of the concentration of the at least one analyte in the sample during the application of the another regular polling sequence;

detect when at least one regular output pulse from the larger sample reaches at least one sample threshold;

apply another extended polling sequence to the larger sample, where the another extended polling sequence substantially eliminates irreversible alteration of the concentration of the at least one analyte in the sample during the application of the another extended polling sequence; and

detect when at least one different extended output pulse from the larger sample reaches at least one volume threshold.

10. The biosensor of claim 1, where the processor is further programmed to improve at least one of a sample output signal and a volume output signal with at least one mediator.

11. The biosensor of claim 10, where the at least one mediator comprises a two electron transfer mediator.

12. The biosensor of claim 1, where the processor is further programmed to determine the concentration of at least one analyte in a sample.

13. The biosensor of claim 12, where the regular and extended polling sequences and the test excitation signal are part of a gated amperometry electrochemical analysis.