Underfill detection system for a biosensor

• US 7,966,859 B2
• Filed: 10/15/2008
• Issued: 06/28/2011
• Est. Priority Date: 05/03/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wu, Huan-Ping, Nelson, Christine D.
• Primary Examiner(s): Noland; Thomas P
• Application Number:
  US12/251,709
• Publication Number:
  US 20090095071A1
• Time in Patent Office: 986 Days
• Field of Search: 73/10.2, 436/8
• US Class Current: 73/1.02
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• 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
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/1016 Control of the volume dispensed or introduced
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A biosensor has an underfill detection system that determines whether a sample of a biological fluid is large enough for an analysis of one or more analytes. The underfill detection system applies an excitation signal to the sample, which generates an output signal in response to the excitation signal. The underfill detection system switches the amplitude of the excitation signal. The transition of the excitation signal to a different amplitude changes the output signal when the sample is not large enough for an accurate and/or precise analysis. The underfill detection system measures and compares the output signal with one or more underfill thresholds to determine whether an underfill condition exists.

Claims

1. A method for detecting an underfill condition in a biosensor, comprising:

applying a test excitation signal to a sample of a biological fluid;

switching the test excitation signal to at least one different amplitude;

measuring a test output signal responsive to a redox reaction of the sample;

comparing the test output signal with at least one underfill threshold; and

detecting an underfill condition in the biosensor from the comparison of the test output signal with the at least one underfill threshold.

2. The method of claim 1, where the test excitation signal has a test pulse width of less than about 5 sec, and where the test excitation signal has a test pulse interval of less than about 15 sec.

3. The method of claim 1, where the at least one different amplitude is lower than an original amplitude.

4. The method of claim 3, where the original and different amplitudes are selected from an output signal plateau in an electrochemical sensor system.

5. The method of claim 4, where the output signal plateau includes excitation amplitudes that generate output signals within ±

5% of an average output signal.

6. The method of claim 1, further comprising switching the test excitation signal to at least one different amplitude essentially during at least one of a start of the test excitation signal, a test pulse, and a transition from one test pulse to another test pulse.

7. The method of claim 1, further comprising:

switching the test excitation signal to a first different amplitude during a test pulse; and

switching the test excitation signal to a second different amplitude during a transition from one test pulse to another test pulse.

8. The method of claim 1, further comprising decreasing the amplitude essentially during at least one of a start of the test excitation signal and transition from one test pulse to another test pulse.

9. The method of claim 1, further comprising decreasing the amplitude the test excitation signal multiple times.

10. The method of claim 1, further comprising generating an error signal in response to an underfill condition.

11. The method of claim 10, further comprising at least one of requesting the addition of biological fluid to the sample in response to the error signal and stopping an analysis of an analyte in the sample in response to the error signal.

12. The method of claim 1, further comprising applying a polling excitation signal to the sample, and switching the test excitation signal to a different amplitude than the polling excitation signal.

13. The method of claim 12, further comprising:

generating a polling output signal in response to the polling excitation signal; and

applying the test excitation signal to the sample when the polling output signal is equal to or greater than a polling threshold.

14. The method of claim 1, where the test excitation signal is part of an assay excitation signal in an electrochemical sensor system.

15. The method of claim 1, further comprising determining if any one test output signal current is equal to or less than the at least one underfill threshold.

16. The method of claim 15, further comprising determining if any one test output signal current is equal to or greater than a second underfill threshold.

17. The method of claim 15, where the text excitation signal includes at least first and second test pulses separated by a test relaxation, the method further comprising:

comparing a difference between a test output signal current of the first test pulse and a test output signal current of the second test pulse with a second underfill threshold.

18. A method for detecting an underfill condition in a biosensor, comprising:

applying a polling excitation signal to a sample of a biological fluid;

applying a test excitation signal to the sample when a polling output signal from the sample is equal to or greater than a polling threshold;

switching the test excitation signal to at least one different amplitude;

measuring a test output signal from the sample;

comparing the test output signal with at least one underfill threshold; and

generating an error signal.

19. A biosensor for determining an analyte concentration in a biological fluid, comprising:

a sensor strip having a sample interface on a base, where the sample interface is adjacent to a reservoir formed by the base;

a measuring device having a processor connected to a sensor interface, where the sensor interface has electrical communication with the sample interface; and

where the processor applies a test excitation signal to the sample interface,

where the processor switches the test excitation signal to at least one different amplitude,

where the processor measures a test output signal responsive to a redox reaction of the sample from the sample interface, and

where the processor compares the test output signal to at least one underfill threshold to determine if the sensor strip is underfilled.

20. The biosensor of claim 19, where the processor applies a polling excitation signal to the sample.

21. The biosensor of claim 20, where the processor switches from the polling excitation signal to the test excitation signal when the polling output signal is equal to or greater than a polling threshold.