Analyte determination method and analyte meter

• US 9,857,324 B2
• Filed: 01/05/2016
• Issued: 01/02/2018
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Harding, Ian, Williams, Richard, Iyengar, Sridhar
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US14/987,895
• Publication Number:
  US 20160169828A1
• Time in Patent Office: 728 Days
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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

The presence of oxygen or red blood cells in a sample applied to an electrochemical test strip that makes use of a reduced mediator is corrected for by an additive correction factor that is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. The measured oxygen carrying capacity can also be used to determine hematocrit and to distinguish between blood samples and control solutions applied to a test strip.

Claims

1. A method for determining an analyte in a sample comprising the steps of:

(a) placing the sample in an electrochemical test cell comprising a working and a counter electrode and a mediator that serves as a charge carrier in the electrochemical determination of the analyte,

(b) electrochemically determining an uncorrected result for the determination of analyte in the sample;

(c) determining an additive correction term for the amount of oxygen in the sample, and

(d) modifying the uncorrected result of step (b) by adding the additive correction term of step (c) to provide a corrected determination of analyte in the sample,

wherein the additive correction term for the amount of oxygen in the sample is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample,

wherein the measurement that reflects the oxygen carrying capacity of the sample is determined applying a potential for a period of time sufficient to establish a chemical potential gradient between the electrodes, switching off the applied potential at a time t_switch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and

wherein the value indicative of the rate of decay is selected from the group consisting of;

a time t_mob, which is determined by determining a time, t_meas, for a function of the slope of the decay of the potential to decay to a predetermined value, and wherein t_mob=t_meas−

t_switch

an instantaneous slope of the decay of potential; and

the change in potential over a predetermined time period after the potential is switched off.

2. The method of claim 1, wherein the value indicative of the rate of decay is a time t_mob, which is determined by determining a time, t_meas for a function of the slope of the decay of the potential to decay to a predetermined value, and wherein t_mob=t_meas−

t_switch, and wherein the function of the slope of the decay is the relationship of voltage, V, to log(t) or ln(t).

3. A meter for receiving an electrochemical test strip having electrodes and providing a determination of an analyte in a sample applied to the electrochemical test strip when received in the meter, said meter comprising

(a) a housing having a slot for receiving an electrochemical test strip;

(b) communications means for receiving input from and communicating a result to a user; and

(c) means for determining an uncorrected result for the determination of analyte in the sample, determining an additive correction term for the amount of oxygen in the sample, and modifying the uncorrected result by adding the additive correction term of step (c) to provide a corrected determination of analyte in the sample,

wherein the additive correction term for the amount of oxygen in the sample is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample,

wherein the measurement that reflects the oxygen carrying capacity of the sample is determined by applying a potential for a period of time sufficient to establish a chemical potential gradient between the electrodes, switching off the applied potential at a time t_switch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and

wherein the value indicative of the rate of decay is selected from the group consisting of;

a time t_mob, which is determined by determining a time, t_meas, for a function of the slope of the decay of the potential to decay to a predetermined value, and wherein t_mob=t_meas−

t_switch;

an instantaneous slope of the decay of potential; and

the change in potential over a predetermined time period after the potential is switched off.

4. The meter of claim 3, wherein the value indicative of the rate of decay is a time t_mob, which is determined by determining a time, t_meas, for a function of the slope of the decay of the potential to decay to a predetermined value, and wherein t_mob=t_meas−

t_switch, and wherein the function of the slope of the decay is the relationship of voltage, V, to log(t) or ln(t).

5. A measurement system comprising a meter in accordance with claim 4, and an electrochemical test strip disposed within the housing.

6. A measurement system comprising a meter in accordance with claim 3, and an electrochemical test strip disposed within the housing.