ACCURATE ANALYTE MEASUREMENTS FOR ELECTROCHEMICAL TEST STRIP TO DETERMINE ANALYTE MEASUREMENT TIME BASED ON MEASURED TEMPERATURE, PHYSICAL CHARACTERISTIC AND ESTIMATED ANALYTE VALUE

• US 20160091451A1
• Filed: 09/25/2014
• Published: 03/31/2016
• Est. Priority Date: 09/25/2014
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: MCCOLL, David, SMITH, Antony
• Application Number:
  US14/496,464
• Publication Number:
  US 20160091451A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Various embodiments for a method that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic signal representative of the sample containing the analyte and selecting an analyte measurement sampling time based on measured temperature, physical characteristic and estimated analyte values.

Claims

1. An analyte measurement system comprising:

a test strip including;

a substrate;

a plurality of electrodes connected to respective electrode connectors; and

an analyte meter including;

a housing;

a test strip port connector configured to connect to the respective electrode connectors of the test strip; and

a microprocessor in electrical communication with the test strip port connector to apply electrical signals or sense electrical signals from the plurality of electrodes during a test sequence,

wherein the microprocessor may be configured, during the test sequence, to;

(a) start an analyte test sequence upon deposition of a sample;

(b) apply a signal to the sample to determine a physical characteristic signal representative of the sample;

(c) drive another signal to the sample;

(d) measure at least one output signal from at least one of the electrodes;

(e) measure a temperature of one of the sample, test strip, or meter;

(f) determine a temperature compensated value for the physical characteristic signal based on the measured temperature;

(g) derive an estimated analyte concentration from the at least one output signal at one of a plurality of predetermined time intervals as referenced from the start of the test sequence;

(h) determine a temperature compensated value for the estimated analyte concentration based on the measured temperature;

(i) select an analyte measurement sampling time point or time interval with respect to the start of the test sequence based on (1) the temperature compensated value of the physical characteristic signal and (2) the temperature compensated value of the estimated analyte concentration;

(j) calculate an analyte concentration based on a magnitude of the output signals at the selected analyte measurement sampling time point or time interval; and

(k) annunciate the analyte concentration.

2. An analyte measurement system comprising:

a test strip including;

a substrate;

a plurality of electrodes connected to respective electrode connectors; and

an analyte meter including;

a housing;

a test strip port connector configured to connect to the respective electrode connectors of the test strip; and

a microprocessor in electrical communication with the test strip port connector to apply electrical signals or sense electrical signals from the plurality of electrodes during a test sequence,

wherein the microprocessor is configured, during the test sequence, to;

(a) start an analyte test sequence upon deposition of a sample;

(b) apply a signal to the sample to determine a physical characteristic signal of

the sample;

(c) drive another signal to the sample;

(d) measure at least one output signal from at least one of the electrodes;

(e) measure a temperature of one of the sample, test strip, or meter;

(f) derive an estimated analyte concentration from the at least one output signal at one of a plurality of predetermined time intervals as referenced from the start of the test sequence;

(g) selecting an analyte measurement sampling time point or time interval with respect to the start of the test sequence based on;

(1) the measured temperature,

(2) the physical characteristic signal,

(3) the estimated analyte concentration;

(i) calculate an analyte concentration based on a magnitude of the output signals at the selected analyte measurement sampling time point or time interval; and

(j) annunciate the analyte concentration.

3. An analyte measurement system comprising:

a test strip including;

a substrate;

a plurality of electrodes connected to respective electrode connectors; and

an analyte meter including;

a housing;

a test strip port connector configured to connect to the respective electrode connectors of the test strip; and

a microprocessor in electrical communication with the test strip port connector to apply electrical signals or sense electrical signals from the plurality of electrodes during a test sequence,

wherein the microprocessor is configured, during the test sequence, to;

(a) start an analyte test sequence upon deposition of a sample;

(b) apply a signal to the sample to determine a physical characteristic signal of

the sample;

(c) drive another signal to the sample;

(d) measure at least one output signal from at least one of the electrodes;

(e) measure a temperature of one of the sample, test strip, or meter;

(f) derive an estimated analyte concentration from the at least one output signal at one of a plurality of predetermined time intervals as referenced from the start of the test sequence;

(g) determine whether the measured temperature is in one of a plurality of temperature ranges;

(h) select an analyte measurement sampling time based on the estimated analyte concentration and the physical characteristic signal representative of the sample in a selected one of a plurality of temperature ranges;

(i) calculate an analyte concentration based on a magnitude of the output signals at the analyte measurement sampling time or time interval from the selected analyte measurement sampling time map; and

(j) annunciate the analyte concentration.

4. The measurement system of claim 3, in which each temperature range of the plurality of temperature ranges comprises a plurality measurement sampling times correlated to respective estimated analyte values and physical characteristics signals.

5. The system of claim 3, in which the plurality of electrodes comprises at least two electrodes to measure the physical characteristic signal and at least two other electrodes to measure the analyte concentration.

6. The system of claim 3, in which the at least two electrodes and the at least two other electrodes are disposed in the same chamber provided on the substrate.

7. The system of claim 3, in which the plurality of electrodes comprises two electrodes to measure the physical characteristic signal and the analyte concentration.

8. The system of claim 3, in which all of the electrodes are disposed on the same plane defined by the substrate.

9. The system of claim 3, in which a reagent may be disposed proximate the at least two other electrodes and no reagent may be disposed on the at least two electrodes.

10. The system of claim 3, in which the one of the plurality of predetermined time intervals for measuring at least one output signal during the test sequence may be about 2.5 seconds after the start of the test sequence.

11. The system of claim 3, in which the one of the plurality of predetermined time intervals comprises a time interval that overlaps a time point of 2.5 seconds after the start of the test sequence.

12. The system of claim 3, in which the other one of the plurality of predetermined time intervals for measuring at least one output signal during the test sequence may be a time point of about 5 seconds after a start of the test sequence.

13. The system of claim 3, in which the one of the plurality of predetermined time intervals comprises any time point at less than five seconds from a start of the test sequence.

14. The system of claim 3, in which the other one of the plurality of predetermined time intervals comprises any time point at less than ten seconds from a start of the test sequence.

15. The system of claim 3, in which the one of the plurality of predetermined time intervals comprises a time interval overlapping a time point of 2.5 seconds after the start of the test sequence and the other of the plurality of predetermined time intervals comprises a time interval overlapping a time point of 5 seconds after the start of the test sequence.

16. A glucose meter comprising:

a housing;

a test strip port connector configured to connect to respective electrical connectors of a biosensor; and

means for;

(a) applying first and second input signals to a sample deposited on the biosensor during a test sequence;

(b) measuring a physical characteristic signal representative of the sample from output signals of one of the first and second input signals;

(c) measuring a temperature of one of the biosensor or the meter;

(d) deriving an estimated a glucose concentration at one of a plurality of predetermined time intervals as referenced from the start of the test sequence based on the other of the first and second input signals;

(e) determining a measurement sampling time based on the measured temperature, physical characteristic signal and the estimated glucose concentration; and

(f) calculating a glucose concentration based on the measurement sampling time; and

an annunciator to provide an output of the glucose concentration from said means.

17. The meter of claim 16, in which the means for measuring includes means for applying a first alternating signal to the biosensor and for applying a second constant signal to the biosensor.

18. The meter of claim 16, in which the means for deriving includes means for estimating an analyte concentration based on a predetermined analyte measurement sampling time point from the start of the test sequence.

19. The meter of claim 16, in which the means for deriving comprises means to correlate the physical characteristic signal to the estimated glucose concentration and the measured temperature.

20. The meter of claim 17, in which the predetermined analyte measurement sampling time interval comprises a time interval at about 2.5 seconds from the start of the test sequence.

21. A method of determining an analyte concentration from a fluid sample with a test strip having at least two electrodes and a reagent disposed on at least one of the electrodes, the method comprising:

depositing a fluid sample on any one of the at least two electrodes to start an analyte test sequence;

applying a first signal to the sample to measure a physical characteristic of the sample;

driving a second signal to the sample to cause an enzymatic reaction of the analyte and the reagent;

estimating an analyte concentration based on a predetermined sampling time point from the start of the test sequence;

measuring temperature of at least one of the biosensor or ambient environment;

obtaining a look up table from a plurality of look-up table indexed to the measured temperature, each look-up table having different qualitative categories of the estimated analyte and different qualitative categories of the measured or estimated physical characteristic indexed against different sampling time points;

selecting a sampling time point from the look-up table obtained in the obtaining step;

sampling signal output from the sample at the selected measurement sampling time from the look-up table obtained in the obtaining step;

calculating an analyte concentration from measured output signal sampled at said selected measurement sampling time in accordance with an equation of the form;

23. The method of claim 21, in which the measuring comprises applying a first signal to the sample to measure a physical characteristic of the sample;

the causing step comprises driving a second signal to the sample;

the measuring comprises evaluating an output signal from at least two electrodes of the biosensor at the selected measurement sampling time after the start of the test sequence, in which the time is set as a function of at least the measured or estimated physical characteristic and the estimated analyte concentration.

25. The method of claim 23, in which the defining comprises selecting a defined time point based on both the measured or estimated physical characteristic and the estimated analyte concentration from the estimating step.

22. A method of determining an analyte concentration from a fluid sample, the method comprising:

depositing a fluid sample on a biosensor to start a test sequence;

causing the analyte in the sample to undergo an enzymatic reaction;

estimating an analyte concentration in the sample;

measuring at least one physical characteristic of the sample;

measuring temperature of at least one of the biosensor or ambient environment;

obtaining a look up table from a plurality of look-up table indexed to the measured temperature, each look-up table having different qualitative categories of the estimated analyte and different qualitative categories of the measured or estimated physical characteristic indexed against different sampling time points;

selecting a sampling time point from the look-up table obtained in the obtaining step;

sampling signal output from the sample at the selected measurement sampling time from the look-up table obtained in the obtaining step; and

determining an analyte concentration from sampled signals at the selected measurement sampling time.

24. The method of claim 22, further comprising estimating an analyte concentration based on a predetermined sampling time point from the start of the test sequence.

26. The method of claim 22, further comprising estimating an analyte concentration based on a measurement of the output signal at a predetermined time.

27. The method of claim 26, in which the predetermined time comprises about 2.5 seconds from the start of the test sequence.

28. The method of claim 26, in which the calculating step comprises utilizing an equation of the form:

29. The method of claim 28, in which the applying of the first signal and the driving of the second signal is sequential.

30. The method of claim 28, in which the applying of the first signal overlaps with the driving of the second signal.

31. The method of claim 30, in which the applying of the first signal comprises directing an alternating signal to the sample so that a physical characteristic of the sample is determined from an output of the alternating signal.

32. The method of claim 31, in which the applying of the first signal comprises directing an electromagnetic signal to the sample so that a physical characteristic of the sample is determined from an output of the electromagnetic signal.

33. The method of claim 22, in which the physical characteristic comprises at least one of viscosity, hematocrit, temperature and density.

34. The method claim 22, in which the physical characteristic comprises hematocrit and the analyte comprises glucose.

35. The method of claim 22, in which the directing comprises driving first and second alternating signal at different respective frequencies in which a first frequency is lower than the second frequency.

36. The method of claim 34, in which the first frequency is at least one order of magnitude lower than the second frequency.

37. The method of claim 34, in which the first frequency comprises any frequency in the range of about 10 kHz to about 250 kHz.

38. The method of claim 22, in which the sampling comprises sampling the signal output continuously at the start of the test sequence until at least about 10 seconds after the start.