Fill error trap for an analyte measurement determined from a specified sampling time derived from a sensed physical characteristic of the sample containing the analyte

• US 9,435,762 B2
• Filed: 06/27/2013
• Issued: 09/06/2016
• Est. Priority Date: 06/27/2013
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: MacKintosh, Stephen
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US13/929,404
• Publication Number:
  US 20150001096A1
• Time in Patent Office: 1,167 Days
• US Class Current: 1/1
• 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 of the sample and determining whether a sample fill condition is erroneous by monitoring the working electrodes and flagging an error if the signal outputs of the working electrodes do not meet certain thresholds.

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, wherein the microprocessor is configured to;

(a) apply a first signal to the plurality of electrodes so that a physical characteristic of a fluid sample is determined;

(b) estimate an analyte concentration based on a signal output at a predetermined sampling time point during a test sequence;

(c) apply a second signal to a first electrode and a second electrode of the plurality of electrodes at a specified sampling time point during the test sequence dictated by the determined physical characteristic, wherein calculating an analyte concentration is facilitated by application of the second signal;

(d) measure a signal output at the specified sampling time point from each of the first and second electrodes;

(e) evaluate whether a value defined by a difference in the magnitudes of the respective signal outputs of the first and second electrodes divided by the magnitude of the signal output of the second electrode is greater than a predetermined threshold;

(f) if the value is less than the predetermined threshold then determine or calculate the analyte concentration from the signal outputs of the first and second electrodes at the specified sampling time and annunciate the analyte concentration; and

(g) if the value is greater than the predetermined threshold then annunciate an error.

2. The system of claim 1, in which the plurality of electrodes comprises four electrodes with the first and second electrodes to measure the analyte concentration and third and fourth electrodes to measure the physical characteristic.

3. The system of claim 2, in which the first, second, third and fourth electrodes are disposed in the same chamber provided on the substrate.

4. The system of claim 2, in which the first and second electrodes and third and fourth electrodes are disposed in respective two different chambers provided on the substrate.

5. The system of claim 2, in which all of the electrodes are disposed on the same plane defined by the substrate.

6. The system of claim 2, in which a reagent is disposed proximate the first and second electrodes and no reagent is disposed on the third and fourth electrodes.

7. The system of claim 2, in which the final analyte concentration is determined from the second signal within about 10 seconds of a start of the test sequence and the predetermined threshold comprises any value from about 10 to about 30.

8. The system of claim 2, in which the sampling time point is selected from a look-up table that includes a matrix in which different qualitative categories of the estimated analyte are set forth in the leftmost column of the matrix and different qualitative categories of the measured or estimated physical characteristic are set forth in the topmost row of the matrix and the sampling times are provided in the remaining cells of the matrix.

9. 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, wherein the microprocessor is configured to;

(a) apply a first signal to the plurality of electrodes so that a physical characteristic of a fluid sample is determined;

(b) estimate an analyte concentration based on a signal output at a predetermined sampling time point during a test sequence;

(c) apply a second signal to a first electrode and a second electrode of the plurality of electrodes at a specified sampling time point during the test sequence dictated by the determined physical characteristic, wherein calculating an analyte concentration is facilitated by application of the second signal;

(d) measure a signal output at the specified sampling time point from each of the first and second electrodes;

(e) evaluate whether a value defined by a difference in the magnitudes of the respective signal outputs of the first and second electrodes divided by the magnitude of the signal output of the second electrode is greater than a predetermined threshold;

(f) if the value is greater than the predetermined threshold then set an error flag as active;

(g) if the value is less than the predetermined threshold then determine or calculate the analyte concentration from the signal outputs of the first and second electrodes at the specified sampling time;

(h) determine whether the error flag is active and if the error flag is not active then annunciate the analyte concentration otherwise if the error flag is active then prohibits annunciation of the analyte concentration.

10. 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 microcontroller in electrical communication with the test strip port connector to apply electrical signals or sense electrical signals from the plurality of electrodes, wherein the microcontroller is configured to;

(a) apply a first signal to the plurality of electrodes so that a physical characteristic of the fluid sample is determined;

(b) estimate an analyte concentration based on a signal output at a predetermined sampling time point during a test sequence;

(c) apply a second signal to first and second electrodes of the plurality of electrodes;

(d) calculate a specified sampling time with an equation of the form;

SpecifiedSamplingTime=x_aH^xb+x_c

where

“

SpecifiedSamplingTime”

is designated as a time point from the start of the test sequence at which to sample the output signal of the test strip,

H represents the percentage physical characteristic of the sample;

x_a represents about 4.3e5 seconds;

x_b represents about −

3.9; and

x_c represents about 4.8 seconds

(e) measure output signals from the first and second electrodes at the specified sampling time during the test sequence;

(f) evaluate whether a value defined by a difference in the magnitudes of the respective signal outputs of the first and second electrodes divided by the magnitude of the signal output of the second electrode is greater than a predetermined threshold;

(g) if the value is less than the predetermined threshold then determine or calculate the analyte concentration from the signal outputs of the first and second electrodes at the specified sampling time and annunciate the analyte concentration; and

(h) if the value is greater than the predetermined threshold then annunciate an error.

11. The system of claim 10, in which the microcontroller determines the analyte concentration with an equation of the form:

12. The system of claim 10, in which the microcontroller estimates the analyte concentration with an equation of the form:

13. The system of claim 12, in which the plurality of electrodes comprises four electrodes with the first and second electrodes to measure the analyte concentration and third and fourth electrodes to measure the physical characteristic.

14. The system of claim 13, in which the first, second, third and fourth electrodes are disposed in the same chamber provided on the substrate.

15. The system of claim 13, in which the first and second electrodes and third and fourth electrodes are disposed in respective two different chambers provided on the substrate.

16. The system of claim 13, in which all of the electrodes are disposed on the same plane defined by the substrate.

17. The system of claim 13, in which a reagent is disposed proximate the first and second electrodes and no reagent is disposed on the third and fourth electrodes.

18. The system of claim 13, in which the final analyte concentration is determined from the second signal within about 10 seconds of a start of the test sequence and the predetermined threshold comprises any value from about 10 to about 30.

19. A method of determining a sample fill error in a biosensor having a plurality of electrodes with first, second, third and fourth electrodes provided with enzymes thereon, the method comprising the steps of:

applying a first signal to the first and second electrodes;

depositing a fluid sample proximate the first, second, third and fourth electrodes;

applying a second signal to the third and fourth electrodes;

determining a physical characteristic of the fluid sample from an output signal of the third and fourth electrodes;

defining a specified sampling time based on the physical characteristic of the fluid sample;

initiating an electrochemical reaction between the first and second electrodes and an analyte in a fluid sample to cause a transformation of the analyte into a byproduct;

measuring signal outputs at the specified sampling time from first and second electrodes during the electrochemical reaction;

evaluating as to whether a value defined by a difference in the magnitudes of the respective signal outputs of the first and second electrodes divided by the magnitude of the signal output of the second electrode is greater than a predetermined threshold;

if the evaluating is true then annunciate a fill error and terminate processing;

if the evaluating step is false then calculating an analyte value representative of a quantity of analyte in the fluid sample from the signal outputs and annunciating the analyte value.

20. The method of claim 19, further comprising:

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

selecting a sampling time point from a 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;

sampling signal output from the sample at the selected sampling time point;

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

21. The method of claim 19, further comprising:

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

selecting a sampling time point based on both the measured or estimated physical characteristic and the estimated analyte concentration.