ANALYTE DETERMINATION METHOD AND ANALYTE METER
First Claim
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1. A method for determining an analyte in a sample comprising the steps of:
- (a) placing the sample in an electrochemical test cell comprising a working and a counter electrode and a mediator that serves as a charge carrier in the electrochemical determination of the analyte, (b) electrochemically determining an uncorrected result for the determination of analyte in the sample;
(c) determining an additive correction factor for the amount of oxygen in the sample, and (d) modifying the uncorrected result of step (b) with the correction factor of step (c) to provide a corrected determination of analyte in the sample, wherein the additive correction factor for the amount of oxygen in the sample is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample.
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Abstract
The presence of oxygen or red blood cells in a sample applied to an electrochemical test strip that makes use of a reduced mediator is corrected for by an additive correction factor that is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. The measured oxygen carrying capacity can also be used to determine hematocrit and to distinguish between blood samples and control solutions applied to a test strip.
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Citations
53 Claims
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1. A method for determining an analyte in a sample comprising the steps of:
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(a) placing the sample in an electrochemical test cell comprising a working and a counter electrode and a mediator that serves as a charge carrier in the electrochemical determination of the analyte, (b) electrochemically determining an uncorrected result for the determination of analyte in the sample;
(c) determining an additive correction factor for the amount of oxygen in the sample, and (d) modifying the uncorrected result of step (b) with the correction factor of step (c) to provide a corrected determination of analyte in the sample, wherein the additive correction factor for the amount of oxygen in the sample is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A meter for receiving an electrochemical test strip having electrodes and providing a determination of an analyte in a sample applied to the electrochemical test strip when received in the meter, said meter comprising
(a) a housing having a slot for receiving an electrochemical test strip; -
(b) communications means for receiving input from and communicating a result to a user; and
(c) means for determining an uncorrected result for the determination of analyte in the sample, determining an additive correction factor for the amount of oxygen in the sample, and modifying the uncorrected result with the correction factor of step (c) to provide a corrected determination of analyte in the sample, wherein the additive correction factor for the amount of oxygen in the sample is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A method for determining hematocrit of a blood sample comprising the steps of:
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(a) introducing a blood sample between first and second electrodes in an electrochemical test cell containing a redox active species that serves as a charge carrier;
(b) applying a potential for period for time sufficient to establish a chemical potential gradient between the electrodes, (c) switching off the applied potential at a time tswitch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and (d) comparing the determined value of the rate of decay with a standard curve relating rate of decay to hematocrit at the determined temperature to arrive at a value for the hematocrit of the sample. - View Dependent Claims (44)
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45. An apparatus for measurement of hematocrit comprising:
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(a) a housing having a slot for receiving an electrochemical test strip;
(b) communications means for receiving input from and communicating a result to a user; and
(c) means for applying a potential for period for time sufficient to establish a chemical potential gradient in a blood sample received between the electrodes, switching off the applied potential at a time tswitch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and (d) means for comparing the determined value of the rate of decay with a standard curve relating rate of decay to hematocrit at the determined temperature to arrive at a value for the hematocrit of the sample. - View Dependent Claims (46, 47)
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48. A method for determination of analyte in which a material is applied to an electrochemical test strip disposed in an analyte detection apparatus, wherein the material may be either a blood sample or a control solution and the signal from the test strip is processed as test sample or a calibration run based on this identification, wherein, the identification of the material as a sample or control solution is performed by the steps of:
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(a) applying a potential for period for time sufficient to establish a chemical potential gradient between the electrodes, (b) switching off the applied potential at a time tswitch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and (c) comparing the determined value of the rate of decay with a threshold value, wherein a value on one side of the threshold value indicates that the material is a blood sample, and a value on the other side of the threshold value indicates that the material is a control solution.
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49. An apparatus for determination of analyte in which a material is applied to an electrochemical test strip disposed in an analyte detection apparatus, wherein the material may be either a blood sample or a control solution and the signal from the test strip is processed as test sample or a calibration run based on this identification, wherein, the identification of the material as a sample or control solution is performed by the steps of:
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(a) means for applying a potential for period for time sufficient to establish a chemical potential gradient between the electrodes, (b) means switching off the applied potential at a time tswitch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and (c) means for comparing the determined value of the rate of decay with a threshold value, wherein a value on one side of the threshold value indicates that the material is a blood sample, and a value on the other side of the threshold value indicates that the material is a control solution.
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50. A method for determining an indication of anemia using a blood sample comprising the steps of:
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(a) introducing a blood sample between first and second electrodes in an electrochemical test cell containing a redox active species that serves as a charge carrier;
(b) applying a potential for period for time sufficient to establish a chemical potential gradient between the electrodes, (c) switching off the applied potential at a time tswitch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and (d) comparing the determined value of the rate of decay with a standard value for the rate of decay corresponding to a threshold value indicative of anemia. - View Dependent Claims (51)
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52. An apparatus for assessment of anemia comprising:
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(a) a housing having a slot for receiving an electrochemical test strip;
(b) communications means for receiving input from and communicating an assessment of anemia to a user; and
(c) means for applying a potential for period for time sufficient to establish a chemical potential gradient in a blood sample received between the electrodes, switching off the applied potential at a time tswitch, and obtaining a value indicative of the rate of decay of the chemical potential gradient in the absence of applied potential, and (d) means for comparing the determined value of the rate of decay with a standard value a standard value for the rate of decay corresponding to a threshold value indicative of anemia. - View Dependent Claims (53)
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Specification