Analysis compensation including segmented signals
First Claim
1. A method of operating a biosensor system, the method using the processor in performing steps comprising:
- providing a biosensor system in the form of an analytical instrument includinga measurement device having electrical circuitry communicatively coupled to a processor, a storage medium, a signal generator, and a sensor interface, the processor having instructions and data stored in the storage medium, anda test sensor having a base and a sample interface, the base forming a reservoir and a channel with an opening, the reservoir being in electrical or optical communication with the measurement device;
receiving the biological fluid sample in the opening of the reservoir, the biological fluid sample flowing through the channel to fill at least in part the reservoir of the test sensor, the biological fluid sample including the analyte;
in response to receiving the biological fluid sample in the reservoir, generating an input signal, by the processor, from the signal generator the input signal including at least two time-separated excitations, each excitation having a respective time period with an end-point;
transmitting the input signal by the sensor interface to the sample interface for applying the input signal to the biological fluid sample;
in response to the input signal and the concentration of the analyte in the biological fluid sample, generating, by the processor, an output signal from the test sensor, the output signal being one or more of a light-generated output signal in response to a light-identifiable species and an electrical output signal generated by a redox reaction;
segmenting, by the processor, within each period of excitation, the output signal during that excitation period into at least two segments with a regular or irregular segmenting interval, each segment including point readings obtained before the end-point of the input signal during that excitation period;
converting, by the processor, the at least two segments into at least two signal processing parameters, wherein the signal processing parameters describe a portion of a total error in the output signal;
determining, by the processor, a segmented signal processing function from the signal processing parameters;
using, by the processor, a predetermined reference correlation to relate the output signal to a plurality of known sample analyte concentrations;
in response to the predetermined reference correlation, using, by the processor, a conversion function to convert the output signal into one known sample analyte concentration of the plurality of known sample analyte concentrations;
determining, by the processor, a compensated value from the output signal in response to the conversion function and the segmented signal processing function;
determining, by the processor, the analyte concentration in the biological fluid sample from the compensated value of the output signal; and
outputting, by the processor, the analyte concentration to one or more of a display, a remote receiver, or a storage medium.
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Abstract
A biosensor system determines analyte concentration from an output signal generated from a light-identifiable species or a redox reaction of the analyte. The biosensor system compensates at least 50% of the total error in the output signal with a primary function and may compensate a portion of the residual error with at least one residual function. A segmented signal processing (SSP) function may serve as the primary function, first residual function, or second residual function. Preferably, when the SSP function serves as the first residual function, the SSP function compensates at least 50% of the residual error remaining after primary compensation. Preferably, when the SSP function serves as the second residual function, the SSP function compensates at least 50% of the residual error remaining after primary and first residual compensation. The error compensation provided by the primary, first residual, and second residual functions may be adjusted with function weighing coefficients.
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Citations
35 Claims
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1. A method of operating a biosensor system, the method using the processor in performing steps comprising:
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providing a biosensor system in the form of an analytical instrument including a measurement device having electrical circuitry communicatively coupled to a processor, a storage medium, a signal generator, and a sensor interface, the processor having instructions and data stored in the storage medium, and a test sensor having a base and a sample interface, the base forming a reservoir and a channel with an opening, the reservoir being in electrical or optical communication with the measurement device; receiving the biological fluid sample in the opening of the reservoir, the biological fluid sample flowing through the channel to fill at least in part the reservoir of the test sensor, the biological fluid sample including the analyte; in response to receiving the biological fluid sample in the reservoir, generating an input signal, by the processor, from the signal generator the input signal including at least two time-separated excitations, each excitation having a respective time period with an end-point; transmitting the input signal by the sensor interface to the sample interface for applying the input signal to the biological fluid sample; in response to the input signal and the concentration of the analyte in the biological fluid sample, generating, by the processor, an output signal from the test sensor, the output signal being one or more of a light-generated output signal in response to a light-identifiable species and an electrical output signal generated by a redox reaction; segmenting, by the processor, within each period of excitation, the output signal during that excitation period into at least two segments with a regular or irregular segmenting interval, each segment including point readings obtained before the end-point of the input signal during that excitation period; converting, by the processor, the at least two segments into at least two signal processing parameters, wherein the signal processing parameters describe a portion of a total error in the output signal; determining, by the processor, a segmented signal processing function from the signal processing parameters; using, by the processor, a predetermined reference correlation to relate the output signal to a plurality of known sample analyte concentrations; in response to the predetermined reference correlation, using, by the processor, a conversion function to convert the output signal into one known sample analyte concentration of the plurality of known sample analyte concentrations; determining, by the processor, a compensated value from the output signal in response to the conversion function and the segmented signal processing function; determining, by the processor, the analyte concentration in the biological fluid sample from the compensated value of the output signal; and outputting, by the processor, the analyte concentration to one or more of a display, a remote receiver, or a storage medium. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A biosensor system for determining an analyte concentration in a biological fluid sample, the biosensor system being an optical system or an electrochemical system, the biosensor system comprising:
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a test sensor having a base and a sample interface, the base forming a reservoir and a channel with an opening, the opening being configured to receive the biological fluid sample and to allow the biological fluid sample to flow through the channel to fill at least in part the reservoir, the reservoir being in electrical or optical communication with the measurement device; a measurement device in electrical or optical communication with the reservoir, the measurement device having electrical circuitry communicatively coupled to a processor, a storage medium, a signal generator, and a sensor interface, the processor having instructions and data stored in the storage medium, the instructions configured such that when executed by the processor the system is enabled so that; in response to receiving the biological fluid sample in the reservoir, the signal generator applies an electrical or optical input signal to the sensor interface, the input signal including at least two time-separated excitations, each excitation having a respective time period with an end-point, the input signal is transmitted by the sensor interface to the sample interface for applying the input signal to the biological fluid sample, in response to the input signal and to the concentration of the analyte in the biological fluid sample, the processor generates an output signal from test sensor, the output signal being one or more of a light-generated output signal in response to a light-identifiable species and an electrical output signal generated by a redox reaction, the processor compensates at least 50% of the total error in the output signal with a primary function, where the primary function describes a major error in the output signal and relates uncompensated output values and error contributors, the major error being attributable to one or more major error contributors selected from a group consisting of temperature, hematocrit, and hemoglobin, if the primary function is not a segmented signal processing function, the processor compensates at least 5% of the remaining error in the output signal with a segmented signal processing function, the processor segments, within each period of excitation, the output signal during that excitation period into at least two segments, each segment including point readings obtained before the end-point of the input signal that excitation period, the processor converts the at least two segments into at least two signal processing parameters wherein the signal processing parameters describe a portion of the total error in the output signal, the processor determines the segmented signal processing function from the signal processing parameter, the processor determines a compensated value from the output signal in response to the primary function and the segmented signal processing function, the processor determines the analyte concentration in the sample from the compensated value, and wherein the processor outputs the analyte concentration to one or more of a display, a remote receiver, or a storage medium.
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34. A method of operating a biosensor system for determining an analyte concentration in a biological fluid sample, the biosensor system being an optical sensor system or an electrochemical sensor system, the biosensor system including a measurement device and a test sensor, the measurement device having a processor, the test sensor being in electrical or optical communication with a reservoir, the method using the processor in performing steps comprising:
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receiving the biological fluid sample in the reservoir of the test sensor, the biological fluid sample including the analyte; applying an input signal to the biological fluid sample, the input signal including at least two time-separated excitations, each excitation having a respective time period with an end-point; generating, via the biosensor system, an output signal responsive to the input signal and further responsive to the concentration of the analyte, the output signal being one or more of a light-generated output signal in response to a light-identifiable species and an electrical output signal generated by a redox reaction; segmenting, within each period of excitation, the output signal during that excitation period into at least two segments, each segment including point readings obtained before the end-point of that excitation period; converting the at least two segments into at least two signal processing parameters, wherein the signal processing parameters describe a portion of a total error in the output signal; determining a segmented signal processing function from the signal processing parameter; determining a compensated value from the output signal in response to the segmented signal processing function; determining the analyte concentration from the compensated value of the output signal; and outputting the analyte concentration to one or more of a display, a remote receiver, or a storage medium.
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35. A method of operating a biosensor system for determining a desired segmented signal processing function that compensates an analyte concentration of a biological fluid sample, the biosensor system being an optical sensor system or an electrochemical sensor system, the biosensor system including a measurement device and a test sensor, the measurement device having a processor, the test sensor being in electrical or optical communication with a reservoir, the method using the processor in performing steps comprising:
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receiving the biological fluid sample in the reservoir of the test sensor, the biological fluid sample including the analyte; applying an input signal to the biological fluid sample, the input signal including at least two time-separated excitations, each excitation having a respective time period with an end-point; generating, via the biosensor system, an output signal responsive to the input signal and further responsive to the concentration of the analyte, the output signal being one or more of a light-generated output signal in response to a light-identifiable species, an electrical output signal generated by an oxidation, an electrical output signal generated by a reduction and an electrical output signal generated by a redox reaction; segmenting, within each period of excitation, the output signal during that excitation period into at least three segments, each segment including point readings obtained before the end-point of that excitation period; converting the at least three segments into at least three segmented signal processing parameters; selecting multiple ones of the at least three segmented signal processing parameters as potential terms in a segmented signal processing function, the selected multiple ones of the at least three segmented signal processing parameters describing at least a portion of a total error in the output signal; determining a first exclusion value for the potential terms; applying an exclusion test responsive to the first exclusion value for the potential terms; identifying one or more of the potential terms for exclusion from the segmented signal processing function; excluding one or more identified potential terms from the segmented signal processing function; determining a desired segmented signal processing function based on at least two remaining identified potential terms of the segmented signal processing function; determining a compensated value from the output signal in response to the desired segmented signal processing function; determining the analyte concentration from the compensated value of the output signal; and outputting the analyte concentration to one or more of a display, a remote receiver, or a storage medium.
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Specification