Methods of failsafing electrochemical measurements of an analyte as well as devices, apparatuses and systems incorporating the same

• US 9,594,052 B2
• Filed: 09/11/2015
• Issued: 03/14/2017
• 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., Chittajallu, Siva
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US14/851,807
• Publication Number:
  US 20150377828A1
• Time in Patent Office: 550 Days
• US Class Current: 1/1
• 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 further allow one to provide an error code or correct and/or compensate for interferents such as an antioxidant before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one DC block, where DC block includes at least one recovery potential, and where a closed circuit condition of the electrode system is maintained during the DC block. The methods use information relating to status of a redox mediator during the electrochemical analysis to provide a statistical antioxidant failsafe using either a classifier or a discriminator to determine whether the antioxidant is interfering with the analyte concentration. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Claims

1. A method of failsafing an electrochemical measurement of an analyte from antioxidant interference, the method of comprising the steps of:

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

an electrode system,

a reagent including a redox mediator in electrical communication with the electrode system, and

a receptacle configured to contact the fluid sample provided to the biosensor,

with a fluid sample in fluidic contact with the reagent, wherein the test sequence comprises at least one direct current (DC) block, wherein the at least one DC block includes a pulsed sequence alternating between at least one excitation potential and at least one recovery potential, and wherein a closed circuit condition of the electrode system is maintained during the at least one recovery potential;

measuring current response information to the test sequence, including information from the at least one excitation potential and the at least one recovery potential;

determining an analyte concentration of the fluid sample utilizing the information of the excitation current response and the recovery current response, the determining compensating for at least one interferent; and

providing a statistical antioxidant failsafe using either a classifier or a discriminator to determine whether an antioxidant is interfering with the analyte concentration, wherein the statistical antioxidant failsafe is based upon information from the at least one DC block that relates to the redox mediator.

2. The method of claim 1, wherein the antioxidant determination is utilized to provide at least 10/10 performance.

3. The method of claim 1, wherein the antioxidant determination is at least in part to reject an analyte concentration measurement or determination.

4. The method of claim 1, wherein the antioxidant determination is at least in part to correct an analyte measurement or determination.

5. The method of claim 1, where the failsafe is activated if the antioxidant level is determined to be greater than 10 mg/dL.

6. A method of failsafing an electrochemical measurement of an analyte in a fluid sample, the method comprising the steps of:

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

an electrode system,

a reagent including a redox mediator in electrical communication with the electrode system, and

a receptacle configured to contact the fluid sample provided to the biosensor,

with the fluid sample in fluidic contact with the reagent, wherein the test sequence comprises at least one direct current (DC) block, wherein the at least one DC block is a slow-ramped bi-polar potential (SRBP) that alternates between about −

450 mV to about +450 mV at two different ramp rates, and wherein a closed circuit condition of the electrode system is maintained during the DC block;

measuring the information from the response to the test sequence; and

providing a reagent layer health failsafe based upon a ratio of an oxidized form of a redox mediator (M_ox) to a reduced form of the redox mediator (M_red), wherein the failsafe prevents reporting of an analyte concentration if M_red is above a predetermined level.

7. The method of claim 6, wherein the failsafe is activated when there is a lack of an expected M_ox feature, wherein the expected M_ox feature is selected from the group consisting of a duration, a shape and/or a magnitude of a current response based upon an amount of M_ox.

8. The method of claim 6, wherein the test sequence further comprises at least one alternating current (AC) block.

9. The method of claim 6, wherein the test sequence further comprises a second DC block.