Concentration Determination in a Diffusion Barrier Layer
First Claim
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1. An electrochemical sensor strip, comprising:
- a base;
a first electrode on the base, the first electrode having at least one first layer on a first conductor, the first layer including a reagent layer and a second layer between the first conductor and the first layer; and
a second electrode on the base, the second layer having an average initial thickness selected in response to a read pulse applied to the first and second electrodes during an analyte analysis, where the read pulse substantially detects a measurable species within the second layer and substantially excludes from detection the measurable species external to the second layer.
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Abstract
The present invention relates to improved electrochemical biosensor strips and methods for determining the concentration of an analyte in a sample. By selectively measuring a measurable species residing in a diffusion barrier layer, to the substantial exclusion of the measurable species residing exterior to the diffusion barrier layer, measurement errors introduced by sample constituents, such as red blood cells, and manufacturing variances may be reduced.
5 Citations
31 Claims
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1. An electrochemical sensor strip, comprising:
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a base; a first electrode on the base, the first electrode having at least one first layer on a first conductor, the first layer including a reagent layer and a second layer between the first conductor and the first layer; and a second electrode on the base, the second layer having an average initial thickness selected in response to a read pulse applied to the first and second electrodes during an analyte analysis, where the read pulse substantially detects a measurable species within the second layer and substantially excludes from detection the measurable species external to the second layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of increasing the accuracy of quantitative analyte determination comprising:
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receiving an analyte containing sample in an electrochemical sensor strip, the analyte containing sample having a liquid component; applying a read pulse between a first conductor and a second conductor on a base of the electrochemical sensor, the read pulse applied for a duration that substantially detects a measurable species within a first layer on the first conductor and substantially excludes from detection the measurable species external to the first layer; measuring a quantitative value of the analyte concentration in the sample in response to the read pulse. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. An electrochemical system, for determining the concentration of an analyte in a sample, comprising:
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a first sensor, the first sensor including; a base, a first electrode on the base, the first electrode having at least one first layer on a first conductor, the first conductor on the base, where the first layer includes at least one binder forming a diffusion barrier layer, and a second electrode; and a measurement device in electrical communication with the first electrode through the first conductor and in electrical communication with the second electrode through a second conductor; where the measurement device applies a read pulse to the first sensor and determines a quantitative value of the analyte concentration in the sample in response to the read pulse; and a bias of the quantitative value of the analyte concentration in the sample determined with the first sensor is less than a bias of a quantitative value of the analyte concentration in the sample when determined by the measurement device using the read pulse when in electrical communication with a second sensor, where the second sensor is identical to the first sensor, but lacks the binder forming the diffusion barrier layer.
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22-26. -26. (canceled)
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27. An electrochemical system, for determining the concentration of an analyte in a sample, comprising:
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a first sensor, the first sensor including; a base, a first electrode on the base, the first electrode having at least one first layer on a first conductor, the first conductor on the base, where the first layer includes at least one binder forming a diffusion barrier layer, and a second electrode; and a measurement device in electrical communication with the first electrode through the first conductor and in electrical communication with the second electrode through a second conductor; where the measurement device applies a read pulse of from 1 to 10 seconds to the first sensor and determines a quantitative value of the analyte concentration in the sample in response to the read pulse; and the accuracy of the determined quantitative value of the analyte concentration in the sample is higher when a shorter read pulse within the read pulse duration from 1 to 10 seconds is applied.
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28-29. -29. (canceled)
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30. An electrochemical system, for determining the concentration of an analyte in a sample, comprising:
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a first plurality of sensors, each sensor of the first plurality of sensors including; a base, a first electrode on the base, the first electrode having at least one first layer on a first conductor, the first conductor on the base, where the first layer includes at least one binder forming a diffusion barrier layer, and a second electrode; and a measurement device; where, when each sensor of the first plurality of sensors is placed in electrical communication with the measurement device and an analyte-containing sample is applied to the sensor, the measurement device applies a read pulse to the sensor and determines a quantitative value of the analyte concentration in the sample in response to the read pulse, and a bias spread for the quantitative values of the analyte concentration determined from the sample by the measurement device in electrical communication with the first plurality of sensors with the read pulse for a plurality of samples having hematocrit concentrations spanning the range from 16% to 48% is less than a bias spread for the plurality of samples when determined by the measurement device in electrical communication with a second plurality of sensors with the read pulse, where the second plurality of sensors is identical to the first plurality of sensors, but lacks the binder forming the diffusion barrier layer.
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31. (canceled)
Specification