Method for determining analyte concentration in a sample technical field

Patent metadata

Field	Value
Publication number	US-11035819-B2
Application number	US-201816021403-A
Country	US
Kind code	B2
Filing date	Jun 28, 2018
Priority date	Jun 28, 2018
Publication date	Jun 15, 2021
Grant date	Jun 15, 2021

Abstract

A method for determining a concentration of an analyte in a fluidic sample is described. A sample is applied to a biosensor including an electrochemical cell having electrodes. A predetermined voltage waveform is applied during at least first and second time intervals. At least first and second current values are measured during the first and second time intervals, respectively. A turning point time is determined during the first time interval at which the measured first current values transition from a first to a second profile. The concentration of analyte in the sample is calculated based on determined turning point time and at least one measured current value. In another example, a physical characteristic of the sample is estimated based on measured current values. The concentration is calculated using a first or second model if the estimated physical characteristic of the sample is in a first or second range, respectively.

First claim

What is claimed is:

1. A method for determining a concentration of an analyte in a fluidic sample, the method comprising:
applying the fluidic sample to a biosensor, the biosensor comprising an electrochemical cell having at least two electrodes;
applying a predetermined voltage waveform comprising a first predetermined voltage applied during at least a first time interval and a second predetermined voltage applied at a second time interval to the at least two electrodes of the biosensor;
using a processor, measuring at least first current values during the first time interval and second current values during the second time interval in which a current i pb representative of a transition from the first predetermined voltage to the second predetermined voltage occurs during an initial portion of the second time interval;
using the processor, determining a turning point time during the first time interval at which the measured first current values transition from a first profile to a second profile; and
using the processor, calculating the concentration of the analyte in the fluidic sample based on the determined turning point time and at least one current value of the measured first and second current values wherein the measured first current values transition from the first profile to the second profile due to a presence of an interferent in the fluidic sample, in which the turning point time occurs prior to the occurrence of i pb .

2. The method of claim 1 , wherein the calculating of the analyte of the fluidic sample is based on the determined turning point time and at least one current value of the measured first current values and at least one current value of the measured second current values.

3. The method of claim 1 , wherein the calculating of the concentration of analyte in the fluidic sample is based on a turning point current value measured at the turning point time.

4. The method of claim 1 , wherein the predetermined voltage waveform further comprising a third predetermined voltage applied during a third time interval, the measuring further comprises measuring third current values during the third time interval, and the calculating of the analyte of the fluidic sample is based on the determined turning point time and at least one current value of the measured first, second and third current values.

5. The method of claim 1 , further comprising:
driving, after applying the fluidic sample to the biosensor, a triggering current between the at least two electrodes of the electrochemical cell;
using the processor, measuring triggering voltage values during driving of the triggering current; and
using the processor, triggering the predetermined voltage waveform upon the measured triggering voltage dropping below a triggering threshold voltage.

6. The method of claim 5 , wherein the triggering current is between 500-700 nA and the triggering threshold voltage is between 800-1,100 mV.

7. The method of claim 1 , wherein the first predetermined voltage of the predetermined voltage waveform is selected to facilitate oxidation of the interferent from the applied sample.

8. The method of claim 1 , wherein the first profile deviates from a Cottrell profile and the second profile follows a Cottrell profile.

9. The method of claim 1 , wherein the interferent comprises uric acid or ascorbic acid.

10. The method of claim 1 , wherein the at least two electrodes of the electrochemical cell comprise a bare electrode and an at least partially reagent covered electrode.

11. The method of claim 1 , wherein the at least two electrodes of the electrochemical cell are one of co-facial or co-planar.

12. The method of claim 1 , wherein the measuring of the first and second current values is at a frequency between 50-200 Hz.

Assignees

• Cilag Gmbh Int
• Lifescan Ip Holdings Llc

Inventors

• Liu Zuifang
• Mccoll David
• Donald Robert
• Salgado Anna
• Smith Antony

Classifications

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/150358

  Strips for collecting blood, e.g. absorbent · CPC title

• A61B5/150022

  for capillary blood or interstitial fluid · CPC title

• G01N27/48

  using polarography, i.e. measuring changes in current under a slowly-varying voltage · CPC title

• G01N27/3274 Primary

  Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771) · CPC title