Method for improving measurement accuracy and devices and systems related thereto

• US 9,970,044 B2
• Filed: 02/17/2016
• Issued: 05/15/2018
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Tonks, Simon
• Primary Examiner(s): Paguio Frising, Michelle F.
• Application Number:
  US15/046,081
• Publication Number:
  US 20160244800A1
• Time in Patent Office: 818 Days
• Field of Search: None
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 27/12 of a solid body in dependence upon absorption of a fluid; of a solid body in dependence upon reaction with a fluid , for detecting components in the fluid
• CPC Class Codes: G01N 27/226 Construction of measuring vessels; Electrodes therefor
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

The present disclosure relates to methods and devices for providing accurate measurement of a property of a sample. The method comprises obtaining a plurality of independent measurements of the property. The plurality of values of the property of the sample obtained by the plurality of independent measurements is compared to determine whether one or more of the values is an outlier.

Claims

1. A meter for measuring hematocrit of a sample, the meter configured for insertion of a sensor comprising a sample chamber comprising a first electrode, a second electrode, and a third electrode, and comprising:

a memory comprising instructions stored therein and coupled to a processor for executing the instructions stored in the memory of the meter, wherein the instructions, when executed, cause the processor to;

determine fill-time by measuring time elapsed between detecting a signal between the first electrode and the second electrode and another signal between the first electrode and the third electrode, wherein the fill-time is related to hematocrit of the sample;

measure a first signal at the second electrode after the sample chamber is filled with the sample, wherein the first signal is independent of the analyte concentration and is related to hematocrit of the sample;

measure a second signal at the third electrode, wherein the second signal is related to hematocrit of the sample;

derive, by using the processor executing instructions stored in the memory, a first hematocrit value, a second hematocrit value and a third hematocrit value of the property using the full-time, the first signal, and the second signal, respectively;

compare the first, second, and third hematocrit values to determine whether one of the values is an outlier; and

calculate a single hematocrit value of the property based on at least two of the first, second, and third hematocrit values that are in agreement.

2. The meter of claim 1, wherein when the first, second, and third hematocrit values are in agreement, and wherein the single hematocrit value is calculated from the first, second, and third hematocrit values.

3. The meter of claim 1, wherein the sensor comprises an enzyme responsive to an analyte and a redox mediator, and wherein the instructions, when executed, cause the processor to:

measure an analyte related signal at the second electrode after determining the fill-time is determined;

determine the concentration of the analyte using the analyte related signal; and

correcting the concentration of the analyte.

4. The meter of claim 1, wherein the first and second signals are selected from voltage, current, resistance, capacitance, charge, conductivity, or a combination thereof.

5. A system for determining concentration of an analyte in a sample, the system comprising an analyte measurement instrument and an analyte sensor,

the analyte sensor comprising a sample chamber comprising a first electrode, a second electrode, and a third electrode;

an enzyme responsive to the analyte and a redox mediator;

the analyte measurement instrument comprising a memory comprising instructions stored therein and coupled to a processor for executing instructions stored in the memory of the instrument, wherein the instructions, when executed, cause the processor to;

determine fill-time by measuring time elapsed between detecting a signal between the first electrode and the second electrode and another signal between the first electrode and the third electrode, wherein the fill-time is related to hematocrit of the sample;

measure a first signal at the second electrode after the sample chamber is filled with the sample, wherein the first signal is independent of the analyte concentration and is related to hematocrit of the sample;

measure an analyte related signal at the second electrode after measuring the first signal;

measure a second signal at the third electrode after measuring the analyte related signal, wherein the second signal is related to hematocrit of the sample;

derive first, second, and third hematocrit values of the sample using the fill-time, the first signal, and the second signal;

compare the first, second, and third hematocrit values of the sample;

calculate a single hematocrit value based on at least two of the first, second and third hematocrit values when the at least two of the first, second, and third hematocrit values are in agreement;

determine concentration of the analyte; and

correct the concentration of the analyte according to the single hematocrit value.

6. The system of claim 5, wherein the single hematocrit value is calculated based on the first, second and third hematocrit values when the first, second, and third hematocrit values of the sample are in agreement.

7. The system of claim 5, wherein the first and second signals are selected from voltage, current, resistance, impedance, capacitance, or a combination thereof.

8. The system of claim 5, wherein the analyte is glucose.

9. The system of claim 8, wherein the enzyme comprises glucose dehydrogenase or glucose oxidase.

10. The system of claim 9, wherein the glucose dehydrogenase is nicotinamide dinucleotide glucose dehydrogenase (NAD-GDH), pyrrole quinoline quinone glucose dehydrogenase (PQQ-GDH), or flavin-adenine dinucleotide glucose dehydrogenase (FAD-GDH).

11. The system of claim 5, wherein the analyte is β

-hyroxybutyrate.

12. The system of claim 11, wherein the enzyme is hydroxybutyrate dehydrogenase.

13. The system of claim 5, wherein the first, second, and third electrodes are coplanar.

14. The system of claim 5, wherein one of the first, second, and third electrodes is in facing configuration with the other two electrodes.

15. The system of claim 5, wherein the electrodes are arranged such that the sample contacts the first electrode before contacting the third electrode.

16. The system of claim 5, wherein the electrodes are arranged such that the sample contacts the second electrode before contacting the third electrode.

17. A system for determining analyte concentration of a sample, the system comprising an analyte sensor and a meter,

the analyte sensor comprising a sample chamber comprising a reference/counter electrode, a working electrode, a trigger electrode, an enzyme responsive to the analyte, and a redox mediator;

the meter comprising a processor for executing instructions stored in a memory of the meter, wherein the memory comprising instructions stored therein is coupled to the processor, wherein the instructions, when executed, cause the processor to;

determine fill-time by measuring time elapsed between detecting a signal between the reference/counter electrode and the working electrode and another signal between the reference/counter electrode and the trigger electrode, wherein the fill-time is related to hematocrit of the sample;

disconnect the reference/counter electrode from the working electrode and from the trigger electrode after the sample chamber is substantially filled with the sample;

reconnect the reference/counter electrode to the working electrode and the trigger electrode;

measure a first signal at the working electrode, wherein the first signal is independent of the analyte concentration and is related to hematocrit of the sample;

measure an analyte related signal at the working electrode after measuring the first signal;

measure a second signal at the trigger electrode after measuring the analyte related signal, wherein the second signal is related to hematocrit of the sample;

derive first, second, and third hematocrit values of the sample using the fill-time, the first signal, and the second signal;

compare the first, second, and third hematocrit values of the sample;

calculate a single hematocrit value based on at least two of the first, second and third hematocrit values when the at least two of the first, second, and third hematocrit values are in agreement;

determine concentration of the analyte; and

correct the concentration of the analyte according to the single hematocrit value.

18. The meter of claim 17, wherein the first and second signals are current, voltage, resistance, impedance, capacitance, or a combination thereof.

19. The meter of claim 17, wherein the first signal is peak interfacial charging current.

20. The meter of claim 19, wherein the second signal is integrated current.

21. The meter of claim 17, wherein the analyte is glucose.

22. The meter of claim 17, wherein the reference/counter electrode, the working electrode and the trigger electrode are coplanar.