Electrochemical methods and devices for use in the determination of hematocrit corrected analyte concentrations
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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
27 Claims
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1-20. -20. (canceled)
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21. An electrochemical cell for determining the concentration of an analyte in a physiological sample, the electrochemical cell comprising:
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a working electrode;
a reference electrode;
a spacer layer between the working and reference electrodes; and
a reaction zone defined by the spacer layer and the working and reference electrodes, said reaction zone comprising an enzyme for producing an electrochemical signal in the presence of the analyte, wherein the reaction zone has a volume of from about 0.1 μ
l to about 10 μ
l;
wherein the electrochemical cell provides a measurement that correlates with the concentration of the analyte in the physiological sample within a period from about 3 to about 20 seconds. - View Dependent Claims (22, 23, 24, 27)
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Specification