Underfill detection system for a biosensor

• US 9,939,406 B2
• Filed: 02/02/2015
• Issued: 04/10/2018
• Est. Priority Date: 05/03/2006
• 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, Nelson, Christine D.
• Primary Examiner(s): Huls, Natalie
• Assistant Examiner(s): Young, Monica S
• Application Number:
  US14/612,177
• Publication Number:
  US 20150144508A1
• Time in Patent Office: 1,163 Days
• Field of Search: 73 102
• 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 biosensor for determining an analyte concentration in a biological fluid, comprising:

a sensor strip having a sample interface on a base, the base forming a reservoir and a channel with an opening, the base further having a surface on which at least one working electrode and at least one counter electrode are disposed, the sample interface having conductors connected to the working electrode and the counter electrode, a biological fluid sample received in the opening flowing through the channel to fill at least in part the reservoir;

a measuring device in electrical or optical communication with the reservoir, the measurement device having electrical circuitry including a processor and a storage medium, the electrical circuitry being communicatively coupled to a signal generator and a sensor interface, the processor having instructions and data stored in the storage medium and being configured to;

in response to receiving the biological fluid sample in the reservoir, instruct the signal generator to apply a test excitation electrical signal to the sensor interface, the test excitation electrical signal being transmitted by the sensor interface to the sample interface for applying the test excitation electrical signal to the biological fluid sample,

switch the test excitation electrical signal to at least one different amplitude during at least one of a start of the test excitation electrical signal, a test pulse, or a transition from one test pulse to another test pulse,

in response to the test excitation electrical signal, generate from the biological fluid sample a first test output electrical signal during a first time interval and a second test output electrical signal during a second time interval, the first time interval being different than the second time interval,

subtract a value of the first test output electrical signal from a value of the second test output electrical signal to determine a value change between the first test output electrical signal and the second test output electrical signal,

compare the value change to a value of at least one underfill threshold, and

determine if the sensor strip is underfilled based on the comparison between the value change and the at least one underfill threshold.

2. The biosensor of claim 1, wherein the processor applies a polling excitation electrical signal to the biological fluid sample.

3. The biosensor of claim 2, wherein the processor switches from the polling excitation electrical signal to the test excitation electrical signal when the polling excitation electrical signal is equal to or greater than a polling threshold.

4. The biosensor of claim 2, wherein the processor applies the polling excitation electrical signal during a polling period of less than 180 seconds, and wherein the processor applies the test excitation electrical signal during a test period of less than 180 seconds.

5. The biosensor of claim 1, wherein the test excitation electrical signal has a test pulse width less than about 5 sec and a test pulse interval less than about 15 sec.

6. The biosensor of claim 1, wherein the at least one different amplitude is lower than an original amplitude, and wherein the original and different amplitudes are selected from an output signal plateau in an electrochemical sensor system.

7. The biosensor of claim 6, wherein the output electrical signal plateau includes excitation amplitudes that generate output electrical signals within ±

5% of an average output electrical signal.

8. The biosensor of claim 1, wherein the processor switches the test excitation electrical signal to a first different amplitude during a test pulse, and wherein the processor switches the test excitation electrical signal to a second different amplitude during a transition from one test pulse to another test pulse.

9. The biosensor of claim 1, wherein the processor reduces the amplitude of at least one test pulse in the test excitation electrical signal below the amplitude of a polling pulse in the polling excitation electrical signal.

10. The biosensor of claim 1, further comprising a display connected to the processor, wherein the processor shows an error signal on the display in response to an underfill condition.

11. The biosensor of claim 10, wherein the error signal requests the addition of biological fluid to the sample in response to the error signal.

12. The biosensor of claim 10, wherein the processor stops an analysis of an analyte in a sample in response to the error signal.

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

providing a biosensor system in form of an analytical instrument including

a sensor strip having a sample interface on a base, the base forming a reservoir and a channel with an opening, the base further having a surface on which at least one working electrode and at least one counter electrode are disposed, the sample interface having conductors connected to the working electrode and the counter electrode, a biological fluid sample received in the opening flowing through the channel to fill at least in part the reservoir, and

a measuring device in electrical or optical communication with the reservoir, the measurement device having electrical circuitry including a processor and a storage medium, the electrical circuitry being communicatively coupled to a signal generator and a sensor interface, the processor having instructions and data stored in the storage medium;

in response to receiving the biological fluid sample in the reservoir, instructing the signal generator, via the processor, to apply a test excitation electrical signal to the sensor interface;

transmitting, via the processor, the test excitation electrical signal by the sensor interface to the sample interface, the test excitation electrical signal including at least first and second test pulses separated by a test relaxation;

switching the test excitation electrical signal to at least one different amplitude during at least one of a start of the text excitation electrical signal, a test pulse, or a transition from one test pulse to another test pulse,

in response to the test excitation electrical signal, generating, via the processor, during a first time interval a first output electrical signal from the first test pulse and during a second time interval a second test output electrical signal from the second test pulse, the first time interval being different than the second time interval;

measuring, via the processor, the first test output signal from the first test pulse;

measuring, via the processor, the second test output signal from the second test pulse;

subtracting, via the processor, a value of the first test output electrical signal from a value of the second test output electrical signal to determine a value change between the first test output electrical signal and the second test output electrical signal;

comparing, via the processor, the value change to a value of at least one underfill threshold; and

detecting, via the processor, if the sensor strip is underfilled based on the comparing between the value change and the at least one underfill threshold.