Methods and systems to determine fill direction and fill error in analyte measurements

• US 9,157,883 B2
• Filed: 03/07/2013
• Issued: 10/13/2015
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Smith, Antony, Whitehead, Neil, Whyte, Lynsey
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US13/788,409
• Publication Number:
  US 20140251833A1
• Time in Patent Office: 950 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• 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 methods and systems that allow for detecting of a direction in which a sample is flowing towards a plurality of electrodes and detecting a fill error of an electrochemical test strip.

Claims

1. A method of determining a sample fill error in an analyte test strip having at least two electrodes spaced apart along a fill passage disposed on a substrate that extends from at least a first opening to a second opening, the method comprising the steps of:

applying a signal to first and second electrodes of the at least two electrodes;

depositing a fluid sample into one of the first and second openings;

monitoring the first and second electrodes for output signals indicative of an electrochemical reaction with the sample; and

in the event the first electrode or the second electrode outputs a signal before the other of the first and second electrodes then monitoring the other of the first and second electrodes for a signal output within a predetermined time period else reporting a fill error when the signal output of the other electrode is after the predetermined time period.

2. The method of claim 1, further comprising:

measuring a signal from the second electrode during a sampling interval of a test sequence time;

comparing a magnitude of the signal from the second electrode with magnitude of the signal from the first electrode; and

reporting an error if the magnitude of the signal from the second electrode is different by a predetermined percent differential from the magnitude of the signal from the first electrode otherwise summing the magnitudes of the signals and calculating an analyte concentration based on the summed magnitudes.

3. The method of claim 1, further comprising:

measuring a signal from the first electrode during a sampling interval of a test sequence time;

comparing a magnitude of the signal from the first electrode with magnitude of the signal from the second electrode; and

reporting an error if the magnitude of the signal from the first electrode is different by a predetermined percent differential from the magnitude of the signal from the second electrode otherwise summing the magnitudes of the signals and calculating an analyte concentration based on the summed magnitudes.

4. The method of one of claim 2 or claim 3, in which the predetermined percent differential comprises any value from about 30% to 10%.

11. The method of one of claim 1 or claim 5, in which the analyte test strip further includes a fifth electrode connected to one of the first, second, third and fourth electrodes.

12. The method of claim 11, in which a reagent is disposed on the first and second electrodes and no reagent on the third and fourth electrodes.

13. The method of claim 12, in which a reference electrode is disposed proximate the first and second electrodes.

14. The method of claim 12, further comprising a fifth electrode disposed proximate the opening closest to one of the third and fourth electrodes.

15. The method of claim 13, in which a reference electrode is disposed between the first and second electrodes.

16. The method of claim 14, in which the reference electrode is connected to the fifth electrode disposed proximate the opening of the passage closest to one of the third and fourth electrodes.

5. A method of determining a sample fill error in an analyte test strip having at least first, second, fourth, and fifth electrodes spaced apart along a fill passage disposed on a substrate that extends from at least a first opening to a second opening, the method comprising the steps of:

applying a signal to the first, second, third, and fourth electrodes;

depositing a fluid sample into one of the first and second openings;

monitoring the first through fourth electrodes for a signal output;

in the event the first electrode outputs a signal greater than a first threshold before one of the third or fourth electrodes outputs a signal greater than a second threshold then;

sampling the signal from the first electrode and

measuring the second, third and fourth electrodes for a signal output from the second electrode greater than the first threshold and a signal output from at least one of the third and fourth electrodes greater than the second threshold within a first predetermined time period otherwise reporting a fill error when the signal output from at least one of the third and fourth electrodes is after the first predetermined time period.

6. The method of claim 5, further comprising the steps of:

in the event one of or both of the third and fourth electrodes output a signal greater than the third threshold before one of the first and second electrodes outputs a signal greater than the first threshold then;

determining whether the first electrode outputs a signal greater than the first threshold before the second electrode and reporting an error if true,

otherwise determining whether the second electrode outputs a signal greater than the first threshold before the first electrode and if true monitoring the first electrode to determine whether the first electrode outputs a signal greater than the first threshold within a second predetermined time period, and

in the event the first electrode fails to outputs a signal greater than the first threshold within the second time period, reporting an error.

7. The method of claim 6, further comprising detecting whether a signal output from the second electrode is greater than a third threshold before a signal output from any one of the first, third and fourth electrodes and if the detecting is true, reporting an error.

8. The method of claim 6, in which the measuring of the second, third and fourth electrodes further comprises comparing a magnitude of the signal from the second electrode with the first electrode and outputting an error whenever a difference in magnitude between the signal of the first electrode and the signal of the second electrode is greater than a predetermined percentage.

9. The method of claim 6, in which the determining further includes comparing a magnitude of the signal from the second electrode with the first electrode and outputting an error whenever a difference in magnitude between the signal of the first electrode and the signal of the second electrode is greater than a predetermined percentage.

10. The method of claim 8, in which the predetermined percent differential comprises any value from about 30% to 10%.

17. A method of determining a sample fill direction for an analyte test strip having at least two electrodes spaced apart along a fill passage disposed on a substrate that extends from at least a first opening to a second opening, the method comprising the steps of:

applying a signal to first and second electrodes of the at least two electrodes;

depositing a fluid sample into one of the first and second openings;

monitoring the first and second electrodes for output signals indicative of an electrochemical reaction;

in the event the first electrode outputs a signal greater than a first predetermined threshold before the second electrodes, storing in memory an indication that a direction of the movement of the sample is in a first direction; and

in the event the second electrode outputs a signal greater than a second predetermined threshold before the first electrode, storing in memory an indication that a direction of the movement of the sample is in a second direction.

18. A method of determining a sample fill direction for an analyte test strip having at least first, second, fourth, and fifth electrodes spaced apart along a fill passage disposed on a substrate that extends from at least a first opening to a second opening such that a sample can move from the first opening toward the second opening or from the second opening toward the first opening, the method comprising the steps of:

applying a signal to the first, second, third, and fourth electrodes;

depositing a fluid sample into one of the first and second openings;

monitoring the first through fourth electrodes for a signal output;

in the event the first electrode outputs a signal greater than a first threshold before one of the third or fourth electrodes outputs a signal greater than a third threshold then;

selecting a first measurement based on output signals from each of the first and second electrodes before a second measurement based on output signals from the third and fourth electrodes; and

in the event the third and fourth electrodes output a signal greater than a second threshold and before any output signal from one of the first and second electrodes then;

selecting the second measurement based on output signals from the third and fourth electrodes before the first measurement based on output signals from each of the first and second electrodes.

19. A system comprising:

a test strip, the test strip including;

a substrate having at least first, second third, fourth, and fifth electrodes disposed in a passage extending between a first opening and a second opening to permit fluid sample to flow into one or more of the openings; and

a test 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 to;

(a) apply a signal to the first, second, third, and fourth electrodes;

(b) monitor the first through fourth electrodes for a signal output representative of a deposition of fluid sample onto the test strip;

(c) in the event the first electrode outputs a signal greater than a first threshold before one of the third or fourth electrodes outputs a signal greater than a second threshold then;

(i) sample the signal from the first electrode and

(ii) measure the second, third and fourth electrodes for a signal output from the second electrode greater than the first threshold and a signal output from at least one of the third and fourth electrodes greater than the second threshold within a first predetermined time period otherwise report a fill error when the signal output from at least one of the third and fourth electrodes is after the first predetermined time period;

(d) in the event one of or both of the third and fourth electrodes output a signal greater than the third threshold before one of the first and second electrodes outputs a signal greater than the first threshold then;

(i) determine whether the first electrode outputs a signal greater than the first threshold before the second electrode and report an error if true,

(ii) otherwise determine whether the second electrode outputs a signal greater than the first threshold before the first electrode and if true monitor the first electrode to determine whether the first electrode outputs a signal greater than the first threshold within a second predetermined time period, and

(e) in the event the first electrode fails to outputs a signal greater than the first threshold within the second time period, report an error.