SYSTEMS AND METHODS OF DISCRIMINATING CONTROL SOLUTION FROM A PHYSIOLOGICAL SAMPLE
First Claim
1. A method for distinguishing between a blood sample and an aqueous non-blood sample, the method comprising:
- (a) applying a first test potential between a first electrode and a second electrode when a sample is introduced into an electrochemical cell and measuring a first current transient;
(b) applying a second test potential between a first electrode and a second electrode, the second test potential being sufficient to oxidize a reduced mediator at the second electrode and measuring a second current transient;
(c) applying a third test potential between a first electrode and a second electrode, the third test potential being sufficient to oxidize a reduced mediator at the first electrode, and measuring a third current transient;
(d) calculating, based on the first current transient, a first reference value;
(e) calculating, based on the second and third current transients, a second reference value; and
(f) determining, based on the first and second reference values, whether the sample is a blood sample or an aqueous non-blood sample.
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Abstract
Methods for distinguishing between an aqueous non-blood sample (e.g., a control solution) and a blood sample are provided herein. In one aspect, the method includes using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or an aqueous non-blood sample based on at least two characteristics (e.g., amount of interferent present and reaction kinetics). The method can also include calculating a discrimination criteria based upon at least two characteristics. Various aspects of a system for distinguishing between a blood sample and an aqueous non-blood sample are also provided herein.
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Citations
24 Claims
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1. A method for distinguishing between a blood sample and an aqueous non-blood sample, the method comprising:
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(a) applying a first test potential between a first electrode and a second electrode when a sample is introduced into an electrochemical cell and measuring a first current transient; (b) applying a second test potential between a first electrode and a second electrode, the second test potential being sufficient to oxidize a reduced mediator at the second electrode and measuring a second current transient; (c) applying a third test potential between a first electrode and a second electrode, the third test potential being sufficient to oxidize a reduced mediator at the first electrode, and measuring a third current transient; (d) calculating, based on the first current transient, a first reference value; (e) calculating, based on the second and third current transients, a second reference value; and (f) determining, based on the first and second reference values, whether the sample is a blood sample or an aqueous non-blood sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A system for distinguishing between a blood sample and an aqueous non-blood sample, the system comprising:
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(a) a test strip including electrical contacts for mating with a test meter and an electrochemical cell comprising; (i) a first electrode and a second electrode in a spaced apart relationship; and (ii) a reagent; and (b) a test meter including a processor adapted to receive current data from the test strip, and data storage containing discrimination criteria for distinguishing a blood sample from an aqueous non-blood sample based on antioxidant concentration and reaction kinetics. - View Dependent Claims (17, 18, 19)
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20. A method for calculating a discrimination criteria for programming into a test meter for distinguishing between a blood sample and an aqueous non-blood sample, the method comprising:
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(a) calculating an interferent index and a residual reaction index for a plurality of aqueous non-blood samples; and (b) calculating a discrimination criteria based on a regression of the interferent index and the residual reaction index for the plurality of aqueous non-blood samples. - View Dependent Claims (21, 22)
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23. A method for distinguishing between a blood sample and an aqueous non-blood sample, the method comprising:
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(a) introducing a sample into an electrochemical cell, the electrochemical cell comprising; (i) two electrodes in a spaced apart relationship; and (ii) a reagent; (b) applying a first test potential, having a first polarity, between the electrodes, and measuring cell current; (c) summing at least two current values measured during the first test potential to generate an interferent index; and (d) using the interferent index to distinguish between a blood sample and an aqueous non-blood sample. - View Dependent Claims (24)
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Specification