Methods of scaling data used to construct biosensor algorithms as well as devices, apparatuses and systems incorporating the same

• US 10,041,902 B2
• Filed: 06/15/2016
• Issued: 08/07/2018
• 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: Buck, Jr., Harvey B., Carpenter, Scott E., Pan, Zheng Zheng, Valverde-Ventura, Rene
• Primary Examiner(s): Noguerola, Alexander Stephan
• Application Number:
  US15/182,654
• Publication Number:
  US 20160320329A1
• Time in Patent Office: 783 Days
• CPC Class Codes: G01N 27/06 of a liquid involving electrolysis G01N27/26
• CPC Class Codes: G01N 27/10 Investigation or analysis specially adapted for controlling or monitoring operations or for signalling
• 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

Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

Claims

1. A method of scaling amperometric data obtained during an electrochemical analysis of an analyte of interest to compensate for hematocrit, the method comprising the steps of:

applying to a body fluid sample a test sequence comprising at least one AC block of low-amplitude signals in connection with at least one DC block, wherein the body fluid sample comprises the analyte of interest;

measuring AC and DC current responses to an electro-active species indicative of the analyte of interest to obtain amperometric data;

determining a solution resistance (R_solution) from the measured AC current response; and

scaling the amperometric data from the measuring step by multiplying the measured DC current responses by R_solution to obtain a compensated voltage drop that minimizes an influence of hematocrit on estimated analyte concentration.

2. The method of claim 1, wherein the AC block comprises a multi-frequency excitation waveform of at least two different frequencies.

3. The method of claim 2, wherein the frequencies are about 10 kHz, about 20 kHz, about 10 kHz, about 2 kHz or about 1 kHz, and wherein each frequency is applied for about 0.5 sec to about 1.5 sec.

4. The method of claim 1, wherein the at least one DC block includes at least one pulse to about ten pulses at a potential that alternates between about 0 mV to about +450 mV, and wherein each pulse is applied for about 50 msec to about 500 msec.

5. The method of claim 4, wherein each DC pulse at about +450 mV is applied for about 250 msec, and each DC pulse at about 0 mV is applied for about 500 msec.

6. The method of claim 1 further comprising the step of estimating the analyte concentration based upon the scaled amperometric data.

7. The method of claim 1, wherein the analyte concentration is a glucose concentration.

8. The method of claim 1, wherein the scaling is based upon a Randles circuit model.

9. The method of claim 1, wherein the scaling uses a slope of fitted impedance values to estimate a Real (Z_R) intercept for a plurality of AC frequencies.

10. The method of claim 1, wherein the scaling further comprises calculating one or more descriptors of the scaled amperometric data.

11. The method of claim 10, wherein the descriptors are calculated by subtracting R_solution from an actual real impedance, and then calculating scaled impedance magnitudes for each frequency.

12. The method of claim 11, wherein the new impedance magnitudes are converted to admittance (Y) magnitudes, and real and imaginary admittance values and corresponding angles are calculated.