Electrochemical methods and devices for use in the determination of hematocrit corrected analyte concentrations
First Claim
1. A method for determining the hematocrit corrected concentration of an analyte in a physiological sample, said method comprising:
- (a) introducing said physiological sample into an electrochemical cell comprising;
(i) spaced apart working and reference electrodes; and
(ii) a redox reagent system comprising an enzyme and a mediator;
(b) applying a first electric potential to said reaction cell and measuring cell current as a function of time to obtain a first time-current transient;
(c) applying a second electric potential to said cell and measuring cell current as a function of time to obtain a second time-current transient; and
(d) deriving a preliminary analyte concentration from said first and second time-current transients; and
(e) multiplying said preliminary analyte concentration less a background value by a hematocrit correction factor to derive said hematocrit corrected analyte concentration in said sample;
whereby the hematocrit corrected concentration of said analyte in said sample is determined.
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Abstract
Methods and devices for determining the concentration of an analyte in a physiological sample are provided. In the subject methods, the physiological sample is introduced into an electrochemical cell having a working and reference electrode. A first electric potential is applied to the cell and the resultant cell current over a period of time is measured to determine a first time-current transient. A second electric potential of opposite polarity is then applied and a second a time-current transient is determined. The preliminary concentration of the analyte is then calculated from the first and/or second time-current transient. This preliminary analyte concentration less a background value is then multiplied by a hematocrit correction factor to obtain the analyte concentration in the sample, where the hematocrit correction factor is a function of the preliminary analyte concentration and the variable γ of the electrochemical cell. The subject methods and devices are suited for use in the determination of a wide variety of analytes in a wide variety of samples, and are particularly suited for the determination of analytes in whole blood or derivatives thereof, where an analyte of particular interest is glucose.
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Citations
20 Claims
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1. A method for determining the hematocrit corrected concentration of an analyte in a physiological sample, said method comprising:
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(a) introducing said physiological sample into an electrochemical cell comprising;
(i) spaced apart working and reference electrodes; and
(ii) a redox reagent system comprising an enzyme and a mediator;
(b) applying a first electric potential to said reaction cell and measuring cell current as a function of time to obtain a first time-current transient;
(c) applying a second electric potential to said cell and measuring cell current as a function of time to obtain a second time-current transient; and
(d) deriving a preliminary analyte concentration from said first and second time-current transients; and
(e) multiplying said preliminary analyte concentration less a background value by a hematocrit correction factor to derive said hematocrit corrected analyte concentration in said sample;
whereby the hematocrit corrected concentration of said analyte in said sample is determined. - View Dependent Claims (2, 3, 4, 5)
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6. A method for determining the hematocrit corrected concentration of an analyte in a whole blood sample, said method comprising:
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(a) introducing said whole blood sample into an electrochemical cell comprising;
(i) spaced apart working and reference electrodes; and
(ii) a redox reagent system comprising an enzyme and a mediator;
(b) applying a first electric potential to said reaction cell and measuring cell current as a function of time to obtain a first time-current transient;
(c) applying a second electric potential to said cell and measuring cell current as a function of time to obtain a second time-current transient; and
(d) deriving a preliminary analyte concentration value from said first and second time-current transients; and
(e) multiplying said preliminary analyte concentration less a background value by a hematocrit correction factor that removes the hematocrit component from said preliminary concentration value to derive said hematocrit corrected analyte concentration in said sample;
whereby the hematocrit corrected concentration of said analyte in said sample is determined. - View Dependent Claims (7, 8, 9, 10)
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11. A method for determining the hematocrit corrected concentration of glucose in a whole blood sample, said method comprising:
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(a) introducing said whole blood sample into an electrochemical cell comprising;
(i) spaced apart working and reference electrodes; and
(ii) a redox reagent system comprising a glucose oxidizing enzyme and a mediator;
(b) applying a first electric potential to said reaction cell and measuring cell current as a function of time to obtain a first time-current transient;
(c) applying a second electric potential to said cell and measuring cell current as a function of time to obtain a second time-current transient; and
(d) deriving a preliminary glucose concentration value from said first and second time-current transients; and
(e) multiplying said preliminary glucose concentration value less a background value by a hematocrit correction factor that removes the hematocrit component from said preliminary concentration value to derive said hematocrit corrected glucose concentration in said sample;
whereby the hematocrit corrected concentration of glucose in said sample is determined. - View Dependent Claims (12, 13, 14, 15, 17, 18, 19, 20)
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16. A meter for amperometrically measuring the concentration of an analyte in a physiological sample, said meter comprising:
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(a) means for applying a first electric potential to an electrochemical cell comprising said sample and measuring cell current as a function of time to obtain a first time-current transient;
(b) means for applying a second electric potential to said electrochemical cell and measuring cell current as a function of time to obtain a second time-current transient;
(c) means for determining a preliminary analyte concentration value and variable γ
from said first and second time-currents; and
(d) means for removing the hematocrit component from said preliminary concentration value to derive said analyte concentration in said sample.
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Specification