Underfill detection system for a biosensor

• US 8,973,422 B2
• Filed: 05/13/2011
• Issued: 03/10/2015
• 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
• Application Number:
  US13/107,363
• Publication Number:
  US 20110265548A1
• Time in Patent Office: 1,397 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, 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;

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

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 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.

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

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

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

10. The method of claim 9, 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.

11. 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.

12. The method of claim 11, 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.

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

14. The method of claim 1, further comprising applying the test excitation signal during a test period, where the test period has less than about 50 test pulse intervals.

15. The method of claim 1, further comprising applying the test excitation signal during a test period, where the test period is less than about 180 sec.