Biosensor for determining a concentration of a biosensor using an underfill procedure

• US 10,724,985 B2
• Filed: 03/06/2018
• Issued: 07/28/2020
• 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:
  US15/913,641
• Publication Number:
  US 20180196000A1
• Time in Patent Office: 875 Days
• Field of Search: 73 28
• 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:

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 non-transitory computer readable storage medium, the electrical circuitry being communicatively coupled to a signal generator and a sensor interface, the processor having instructions and a data stored in the non-transitory computer readable storage medium;

applying, via the processor, a pulse sequence to the biosensor system, the pulse sequence comprising

applying a plurality of pulses including a first pulse and a second pulse,

measuring, for each pulse of the plurality of pulses, a series of sensor currents in response to the respective pulse, a first series of sensor currents being measured in response to the first pulse, a second series of sensor currents being measured in response to the second pulse;

adjusting, via the processor, a slope value and an intercept value of a calibration for the biosensor system for a temperature effect

calculating, via the processor, a glucose concentration of the biological fluid sample using the adjusted calibration; and

checking, via the processor, for underfill of the sample in the biosensor system, the checking including

setting an error mode to “

underfill”

if a last measured current in the second series is less than a current threshold for underfill, or

setting an error mode to “

underfill”

if the difference of a last measured current in the first series and a first measured current in the second series is greater than a current delta threshold for underfill.

2. The method of claim 1, further comprising detecting, via the process, an application of the biological fluid sample in the reservoir.

3. The method of claim 2, wherein the detecting includes

applying a polling excitation signal to the biosensor system;

and

measuring a polling output current from the biosensor system.

4. The method of claim 3, wherein the detecting further includes

determining if the polling output current exceeds a polling threshold, and

measuring another polling output current from the biosensor system after a first delay.

5. The method of claim 4, wherein the detecting further includes starting a time count.

6. The method of claim 1, further comprising:

generating an error signal in response to setting the error mode to underfill; and

requesting addition of biological fluid to the biological fluid sample in response to the error signal.

7. The method of claim 1, wherein the second pulse is applied after a delay.

8. The method of claim 7, wherein the plurality of pulses further includes a third pulse, a fourth pulse, and a fifth pulse, the third pulse, a third series of sensor currents being measured in response to the third pulse, a fourth series of sensor currents being measured in response to the fourth pulse, a fifth series of sensor currents being measured in response to the fifth pulse.

9. The method of claim 8, wherein each of the third pulse, the fourth pulse, and the fifth pulse is applied after a respective delay.

10. The method of claim 1, further comprising requesting addition of biological fluid to the biological fluid sample in response to the “

underfill”

error mode.

11. A method for determining an analyte concentration in a sample of a biological fluid, 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, 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 non-transitory computer readable storage medium, the processor having instructions and a data stored in the non-transitory computer readable storage medium;

detecting, via the processor, an application of the biological fluid sample in the reservoir, the detecting including

applying a polling excitation signal to the biosensor system,

measuring a polling output current from the biosensor system,

determining if the polling output current exceeds a polling threshold, and

measuring another polling output current from the biosensor system after a first delay, and

starting a time count;

applying, via the processor, a pulse sequence to the biosensor system, the pulse sequence comprising

applying a first pulse,

measuring a first series of sensor currents in response the first pulse,

applying a second pulse,

measuring a second series of sensor currents in response the second pulse,

applying a third pulse after a second delay,

measuring a third series of sensor currents in response the third pulse,

applying a fourth pulse after a third delay,

measuring a fourth series of sensor currents in response the fourth pulse,

applying a fifth pulse after a fourth delay, and

measuring a fifth series of sensor currents in response the fifth pulse;

adjusting, via the processor, a slope value and an intercept value of a calibration for the biosensor system for a temperature effect;

calculating, via the processor, a glucose concentration of the biological fluid sample using the adjusted calibration; and

checking, via the processor, for underfill of the sample in the biosensor system, the checking including

setting an error mode to “

underfill”

if a last measured current in the second series is less than a current threshold for underfill, or

setting an error mode to “

underfill”

if the difference of a last measured current in the first series and a first measured current in the second series is greater than a current delta threshold for underfill.