Method for improving measurement accuracy and devices and systems related thereto

• US 9,273,337 B2
• Filed: 12/19/2013
• Issued: 03/01/2016
• Est. Priority Date: 12/21/2012
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Tonks, Simon
• Primary Examiner(s): Claytor, Renee
• Assistant Examiner(s): Paguio Frising, Michelle F
• Application Number:
  US14/134,769
• Publication Number:
  US 20140178909A1
• Time in Patent Office: 803 Days
• Field of Search: None
• US Class Current: 1/1
• 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 method for measuring hematocrit of a sample, the method comprising:

contacting the sample with a sensor inserted into a meter, the sensor comprising a sample chamber comprising a first electrode, a second electrode, and a third electrode, the meter comprising a memory and a processor for executing instructions stored in a memory of the instrument, the instructions comprising instructions for;

determining 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;

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

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

deriving, 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 fill-time, the first signal, and the second signal, respectively;

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

calculating 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 method of claim 1, wherein when the first, second, and third hematocrit values are in agreement, the method comprises obtaining a single hematocrit value from the first, second, and third hematocrit values.

3. The method of claim 1, wherein the sensor comprises an enzyme responsive to an analyte and a redox mediator, the method further comprising measuring an analyte related signal at the second electrode after determining the fill-time;

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

correcting the concentration of the analyte.

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

5. The method of claim 3, wherein the analyte is glucose.

6. The method of claim 3, wherein the enzyme comprises glucose dehydrogenase or glucose oxidase.

7. The method of claim 6, wherein the glucose dehydrogenase is nicotinamide dinucleotide glucose dehydrogenase (NAD-GDH), or pyrrole quinoline quinone glucose dehydrogenase (PQQ-GDH), or flavin-adenine dinucleotide glucose dehydrogenase (FAD-GDH).

8. The method of claim 3, wherein the analyte is β

-hyroxybutyrate.

9. The method of claim 3, wherein the enzyme is hydroxybutyrate dehydrogenase.

10. The method of claim 1, wherein the first, second, and third electrodes are coplanar.

11. The method of claim 1, wherein one of the first, second, and third electrodes is in facing configuration with the other two electrodes.

12. The method of claim 1, wherein the electrodes are arranged such that the sample contacts the first electrode before contacting the third electrode.

13. The method of claim 12, wherein the electrodes are arranged such that the sample contacts the second electrode before contacting the third electrode.

14. A method for using an analyte sensor, the method comprising:

contacting a sample comprising an analyte with an 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;

using an analyte measurement instrument in which the analyte sensor is inserted to determine concentration of the analyte, the analyte measurement instrument comprising a processor for executing instructions stored in a memory of the instrument, the instructions comprising instructions for;

determining 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;

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

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

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

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

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

calculating 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;

determining concentration of the analyte; and

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

15. The method of claim 14, wherein the method comprises calculating a single hematocrit value based on the first, second and third hematocrit values when the first, second, and third hematocrit values of the sample are in agreement.

16. The method of claim 14, wherein the first and second signals are selected from the group consisting of voltage, current, resistance, impedance, capacitance, or combination thereof.

17. The method of claim 14, wherein the analyte is glucose.

18. The method of claim 14, wherein the enzyme comprises glucose dehydrogenase or glucose oxidase.

19. The method of claim 18, 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).

20. The method of claim 14, wherein the analyte is β

-hyroxybutyrate.

21. The method of claim 14, wherein the enzyme is hydroxybutyrate dehydrogenase.

22. The method of claim 14, wherein the first, second, and third electrodes are coplanar.

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

24. The method of claim 14, wherein the electrodes are arranged such that the sample contacts the first electrode before contacting the third electrode.

25. The method of claim 14, wherein the electrodes are arranged such that the sample contacts the second electrode before contacting the third electrode.

26. A method for determining analyte concentration of a sample using an analyte sensor and a meter, the method comprising:

contacting the sample with the analyte sensor inserted into the 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;

using the meter comprising a processor for executing instructions stored in a memory of the meter, the instructions comprising instructions for;

determining 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;

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

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

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

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

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

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

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

calculating 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;

determining concentration of the analyte; and

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

27. The method of claim 26, wherein the first and second signals are selected from current, voltage, resistance, impedance, capacitance, or combination thereof.

28. The method of claim 26, wherein the first signal is peak interfacial charging current.

29. The method of claim 28, wherein the second signal is integrated current.

30. The method of claim 29, wherein the analyte is glucose.

31. The method of claim 26, wherein the reference/counter electrode, the working electrode and the trigger electrode are coplanar.