ELECTROCHEMICAL ANALYTE MEASUREMENT METHOD AND SYSTEM
First Claim
1. A method for determining a glucose concentration measurable with a system having a test strip and a meter having a test circuit including a microprocessor, the method comprising:
- applying, with the test circuit, a first test voltage between a reference electrode and a second working electrode coated with a reagent layer of the test strip and applying a second test voltage between the reference electrode and a first working electrode coated with a reagent layer;
measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample is applied to the test strip;
measuring a fifth test current at the first working electrode;
determining, with the microprocessor, a glucose concentration based on the first, second, third, fourth and fifth test currents; and
annunciating the glucose concentration.
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Accused Products
Abstract
Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a first test voltage between a reference electrode and a second working electrode and applying a second test voltage between the reference electrode and a first working electrode; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing an analyte is applied to the test strip; measuring a fifth test current at the first working electrode; estimating a hematocrit-corrected analyte concentration from the first, second, third, fourth and fifth test currents; and annunciating the hematocrit-corrected analyte concentration.
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Citations
25 Claims
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1. A method for determining a glucose concentration measurable with a system having a test strip and a meter having a test circuit including a microprocessor, the method comprising:
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applying, with the test circuit, a first test voltage between a reference electrode and a second working electrode coated with a reagent layer of the test strip and applying a second test voltage between the reference electrode and a first working electrode coated with a reagent layer; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample is applied to the test strip; measuring a fifth test current at the first working electrode; determining, with the microprocessor, a glucose concentration based on the first, second, third, fourth and fifth test currents; and annunciating the glucose concentration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for determining a glucose concentration measurable with a system having a test strip and a meter, the method comprising:
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applying a first test voltage between a reference electrode and a second working electrode coated with a reagent layer and applying a second test voltage between a reference electrode and a first working electrode coated with a reagent layer; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing glucose is applied to the test strip; measuring a fifth test current at the first working electrode; determining the glucose concentration from the first, second, third, fourth and fifth test currents with an equation of the form; - View Dependent Claims (16)
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17. A method for determining a hematocrit-corrected test current measurable with a system having a test strip and a meter, the method comprising:
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applying a first test voltage between a reference electrode and a second working electrode coated with a reagent layer and applying a second test voltage between a reference electrode and a first working electrode coated with a reagent layer; measuring a first test current, a second test current, a third test current and a fourth test current at the second working electrode after a blood sample containing glucose is applied to the test strip; measuring a fifth test current at the first working electrode; and determining the hematocrit-corrected test current by determining a ratio of the first test current to the second test current raised to a power term and multiplying the ratio by the fifth test current, where the power term is a function of a first tuning parameter and a second tuning parameter. - View Dependent Claims (18, 19, 20, 21)
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22. An analyte measurement system to measure a glucose concentration in physiological fluid of a user, the system comprising:
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a test strip including a substrate having a reference electrode, a first working electrode and a second working electrode coated with a reagent layer having a mediator, the electrodes being connected to corresponding contact pads; and an analyte meter having a microprocessor and a test circuit in connection with a test strip port that receives the contact pads of the test strip so that the meter is configured to apply a test voltage after deposition of physiological fluid on the electrodes and determine a hematocrit-corrected glucose concentration from measured first, second, third, fourth and fifth test currents at first, second, third, fourth and fifth discrete intervals after application of the test voltage by the meter. - View Dependent Claims (24, 25)
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23. An analyte measurement system to measure a glucose concentration in physiological fluid of a user, the system comprising:
a test strip including a substrate having a reference electrode, a first working electrode and a second working electrode coated with a reagent layer having a mediator, the electrodes being connected to corresponding contact pads; and an analyte meter having a microprocessor and a test circuit in connection with a test strip port that receives the contact pads of the test strip so that the meter is configured to apply a test voltage after deposition of physiological fluid on the electrodes and determine a hematocrit-corrected glucose concentration from measured first, second, third, fourth and fifth test currents so that at least 97% of plural samples are within an ISO (International Standards Organization) bias criteria of about ±
20%, with at least 85% of the plural samples are within ISO bias criteria of about ±
15%, and at least 69% of the samples are within ISO bias criteria of about ±
10%.
Specification