Descriptor-based methods of electrochemically measuring an analyte as well as devices, apparatuses and systems incorporating the same

• US 10,295,494 B2
• Filed: 09/11/2015
• Issued: 05/21/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Carpenter, Scott E., Pan, Zheng Zheng
• Primary Examiner(s): Mekhlin, Eli S
• Application Number:
  US14/852,044
• Publication Number:
  US 20150377820A1
• Time in Patent Office: 1,348 Days
• Field of Search: None
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence

Abstract

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods allow one to correct and/or compensate for confounding variables such as hematocrit, salt concentration and/or temperature before providing an analyte concentration. The measurement methods use response information from a test sequence having at least one DC block, where DC block includes at least one excitation pulse and at least one recovery pulse, and where a closed circuit condition of an electrode system is maintained during the at least one recovery pulse. Information encoded in the excitation and recovery pulses are used to build within- and across-pulse descriptors to correct/compensate for hematocrit, salt concentration and/or temperature effects on the analyte concentration. Methods of transforming current response data also are disclosed. Further disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Claims

1. A method of electrochemically measuring an analyte in a fluid sample, the method comprising the steps of:

applying an electrical test sequence to an electrochemical biosensor, the electrochemical biosensor comprising;

an electrode system,

a reagent in electrical communication with the electrode system, and

a receptacle configured to contact the fluid sample provided to the electrochemical biosensor, with the fluid sample in fluidic contact with the reagent, wherein the electrical test sequence comprises at least one direct current (DC) block, the at least one DC block includes at least one excitation potential pulse and at least one recovery potential pulse, each potential configured to produce response information to the electrical test sequence, and wherein a closed circuit condition of the electrode system is maintained during the at least one DC block;

measuring the response information from the at least one DC block of the electrical test sequence;

building descriptors encoding magnitude and shape characteristics of the response information to the electrical test sequence, wherein the descriptors encode transformed slope information and transformed intercept information in the response information for at least one excitation current response or recovery current response;

determining an effective current using the descriptors; and

determining an analyte concentration of the fluid sample based upon the effective current determined using the descriptors, wherein the analyte concentration is a glucose concentration.

2. The method of claim 1, wherein the transformed slope information and the transformed intercept information pertain to an x-y coordinate system, and wherein x=ln(time) and y = ln(current).

3. The method of claim 1, wherein the effective current is proportional to the analyte concentration of the fluid sample.

4. The method of claim 3, wherein the effective current is determined in accordance with the following equation:

5. The method of claim 4, wherein N=9 and pulses i=1, 3, 5, 7, and 9 comprise excitation potentials.

6. The method of claim 1, wherein the fluid sample is blood.

7. The method of claim 6, wherein the analyte concentration varies from an actual concentration of the analyte in the blood by +/−

10% or less, and wherein the blood comprises hematocrit from about 20% to about 70%.

8. The method of claim 6, wherein the analyte concentration varies from an actual concentration of the analyte in the blood by +/−

10% or less, and wherein the blood comprises salt from about 140 mg/dL to about 180 mg/dL.

9. The method of claim 6, wherein the analyte concentration varies from an actual concentration of the analyte in the blood by +/−

10% or less, and wherein the blood has a temperature from about 6°

C. to about 44°

C.

10. The method of claim 6, wherein the analyte concentration varies from an actual concentration of the analyte in the blood by +/−

10% or less, wherein the blood comprises (a) hematocrit from about 20% to about 70% , and (b) salt from about 140 mg/dL to about 180 mg/dL, and wherein the blood has a temperature from about 6°

C. to about 44°

C.

11. The method of claim 1, wherein magnitude and shape of the excitation current response information and the response current response information are defined by points in an x-y space, wherein x=ln(time) and y=ln(current).

12. The method of claim 1, wherein the electrical test sequence further comprises an alternating current (AC) block, and the glucose concentration is further determined based on an effective phase and an effective admittance determined in an AC block current response.

13. The method of claim 12, wherein the glucose concentration is determined in accordance with the following equation:

Predglu=a0 +(b0+exp(b1+b2*I_eff+P_eff+Y_eff))*(I_eff),

wherein a0, b0, b1, and b2 are optimized constants, I_eff is the effective current, P_eff is the effective phase of the AC block current response, and Y_eff is the effective admittance of the AC block current response.

14. The method of claim 13, wherein P_eff is determined in accordance with the equation:

P_eff=bp2*(p11*cos(α

)+p12*sin(α

))+bp3*(−

p11*sin(α

)+p12*cos(α

)),

wherein α

=arctan(1), p11 is a 20 kHz AC phase, p12 is a 10 kHz AC phase, and bp2 and bp3 are optimized weighting coefficients.

15. The method of claim 13, wherein Y_eff is determined in accordance with the equation:

Y_eff=by2*(y11*cos(α

)+y12*sin(α

))+by3*(−

y11*sin(α

)+y12*cos(α

)),

wherein α

=arctan(1), y11 is a 20 kHz AC admittance, y12 is a 10 kHz AC admittance, and by2 and by3 are optimized weighting coefficients.

16. The method of claim 12, wherein the glucose concentration is determined in accordance with the following equation:

Predglu=a0+a1*_eff+exp(b0 +P_eff+Y_eff)*I_eff,

wherein a0, a1, and b0 are optimized constants, I_eff is the effective current, P_eff is the effective phase of the AC block current response, and Y_eff is the effective admittance of the AC block current response.

17. The method of claim 1 wherein the glucose concentration is determined in accordance with the following equation:

Predglu=a0 +(b0 +exp(b1+b2*I_eff))*(I_eff),

wherein a0, b0, b1, and b2 are optimized constants and I_eff is the effective current.

18. The method of claim 1, wherein the glucose concentration is determined in accordance with the following equation:

Predglu=a0+a1*I_eff+exp(b0)*I_eff,

wherein a0, a1, and b0 are optimized constants and I_eff is the effective current.