Biosensors and methods for determining analyte concentration in the kinetic potential region of redox mediators

A method of determining an initial input potential for a test sensor based on the manufactured sensitivity of the test sensor, for performing an analysis of a sample with the test sensor, the method comprising:

• applying a first and second calibration input potentials to a test sensor contacting a sample, where the first and second calibration input potentials are within a kinetic potential region of a redox mediator of the test sensor;
• measuring output currents responsive to the first and the second calibration input potentials from the test sensor;
• determining a regression sensitivity relationship from the measured output currents responsive to the first and the second calibration input potentials using a known laboratory analyte concentration or a reference analyte concentration of the sample by modifying the measured output currents responsive to the first and the second calibration input potentials with the known laboratory analyte concentration or the reference analyte concentration of the sample;
• determining an initial input potential by multiplying a slope from the regression sensitivity relationship by a selected sensitivity and combining with an intercept from the regression sensitivity relationship.

A method of determining an initial input potential for a test sensor based on the manufactured sensitivity of the test sensor, for performing an analysis of a sample with the test sensor, the method comprising:

• applying a first and second calibration input potentials to multiple test sensors contacting a sample, where the first and the second calibration input potentials are within a kinetic potential region of a redox mediator of the test sensor;
• measuring output currents responsive to the first and the second calibration input potentials from the multiple test sensors;
• determining a first calibration input potential regression relationship and a second calibration input potential regression relationship from the output currents measured from the multiple test sensors and a known laboratory analyte concentration or a reference analyte concentration to obtain a first calibration input potential change rate and a second calibration input potential change rate;
• determining pair point relationship for a single test sensor from a rising slope (RS) value of the single test sensor, a selected sensitivity, and the intercept of the first and second calibration input potential regression relationships;
• determining a change rate relationship from the first and second calibration input potentials and the first and second calibration input potential change rates;
• and
• determining an initial input potential for the test sensor from the change rate relationship and a single test sensor change rate determined from the pair point relationship.

An analyte measurement device, comprising:

• a processor in electrical communication with a signal generator and a storage medium,
• where the processor is configured to measure output currents responsive to input potentials,
• where the signal generator is configured to provide the input potentials to working and counter electrodes of a test sensor and transferring output currents responsive to the input potentials from the test sensor to the processor;
• where the processor is configured to instruct the signal generator to apply a first and second calibration input potentials to the test sensor, where the first and second calibration input potentials are within a kinetic potential region of a redox mediator of the test sensor;
• where the processor is configured to measure output currents responsive to the first and the second calibration input potentials;
• where the processor is configured to determine a regression sensitivity relationship from the measured output currents responsive to the first and the second calibration input potentials;
• where the processor is configured to determine a first analysis input potential within the kinetic potential region of the redox mediator from the regression sensitivity relationship;
• where the processor is configured to instruct the signal generator to apply the first analysis input potential to the test sensor;
• where the processor is configured to measure output currents responsive to the first analysis input potential from the test sensor;
• where the processor is configured to determine the analyte concentration of a sample in response to the measured output currents responsive to the first analysis input potential;
• and
• where the processor is configured to report the determined analyte concentration to a user.

A biosensor system for determining an analyte concentration in a sample, comprising:

• a test sensor comprising working and counter electrodes and a redox mediator;
• a measurement device comprising a processor in electrical communication with a signal generator and a storage medium, where the working and the counter electrodes are in electrical communication with the signal generator;
• where the processor is configured to measure output currents responsive to input potentials from the test sensor,
• where the signal generator is configured to provide the input potentials to the working and the counter electrodes and transferring output currents responsive to the input potentials from the working and the counter electrodes to the processor;
• where the processor is configured to instruct the signal generator to apply a first and second calibration input potentials to the working and the counter electrodes, where the first and second calibration input potentials are within a kinetic potential region of the redox mediator;
• where the processor is configured to measure output currents responsive to the first and the second calibration input potentials;
• where the processor is configured to determine a regression sensitivity relationship from the measured output currents responsive to the first and the second calibration input potentials;
• where the processor is configured to determine a first analysis input potential within the kinetic potential region of the redox mediator from the regression sensitivity relationship;
• where the processor is configured to instruct the signal generator to apply the first analysis input potential to the working and the counter electrodes;
• where the processor is configured to measure output currents responsive to the first analysis input potential from the working and the counter electrodes;
• where the processor is configured to determine the analyte concentration of a sample in response to the measured output currents responsive to the first analysis input potential;
• and
• where the processor is configured to report the determined analyte concentration to a user.