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

• US 9,395,322 B2
• Filed: 09/11/2015
• Issued: 07/19/2016
• 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, Harvey B. Jr., Carpenter, Scott E., Pan, Zheng Zheng, Valverde-Ventura, Rene
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US14/851,444
• Publication Number:
  US 20160041117A1
• Time in Patent Office: 312 Days
• US Class Current: 1/1
• 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 variations in electrode conductivity, the method comprising the steps of:

applying an electrical test sequence to a body fluid sample in an electrochemical biosensor, the 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 biosensor,

wherein the test sequence comprises at least one AC block of low-amplitude signals and at least one DC block, and 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;

measuring at least two loop resistances of the electrode system of the biosensor, wherein a first loop resistance is measured between two contact pads associated with a trace of a working electrode, and wherein a second loop resistance is measured between two contact pads associated with a trace of a counter electrode;

normalizing the at least two loop resistances (R_conductor) by dividing a first loop resistance by a first constant and by dividing a second loop resistance by a second constant to obtain normalized loop resistances;

scaling the amperometric data by incorporating the lowest normalized loop resistance into an algorithm for determining an analyte concentration or a failsafe calculation.

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 and about 1 kHz, and wherein each is applied for about 0.5 sec to about 1.5 sec.

4. The method of any 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, wherein the first constant and the second constant are a pre-determined median resistance value.

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

8. The method of claim 1 further comprising the step of providing a failsafe that incorporates R_conductor as a parameter into a failsafe algorithm, wherein the failsafe prevents reporting or displaying of the analyte concentration if the variations in electrode conductivity are above a predetermined threshold.

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

10. The method of claim 1, wherein the variations in electrode conductivity are selected from the group consisting of variations in conductive layer thickness within the electrode system, scratches within the electrode system, defects within the electrode system, and contact resistance variations between biosensor contact pads and a meter contact.