Analyte determination method and analyte meter
Inventors
Harding, Ian • Williams, Richard • Iyengar, Sridhar
Assignees
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Publication Number
US-11408849-B2
Publication Date
2022-08-09
Expiration Date
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.
Core Innovation
The invention relates to an electrochemical analyte system and a meter that measures an analyte in a sample that can be either a blood sample or a control sample. The meter comprises a programmed microprocessor that determines hematocrit and then processes the sample as either a blood sample or a control sample depending on the hematocrit determination. This processing includes measuring an analyte amount and presenting the measured amount to a user.
The system compensates oxygen effects by using a reduced mediator and an additive correction factor associated with oxygen carrying capacity. The correction factor is determined from sample temperature and a measurement reflecting oxygen carrying capacity, including using mediator mobility t_mob obtained from post-potential-switch-off potential decay.
The described approach includes deriving mediator mobility t_mob and using it to compute an additive correction to a raw or uncorrected analyte concentration. The architecture also supports dynamic measurement switching from amperometric mode to potentiometric mode based on determination of t_switch and related timing and potential-decay behavior.
Claims Coverage
The partial content identifies two independent claims. Across these claims, the inventive coverage centers on hematocrit determination to classify a sample as blood or control, and on electrochemical analyte measurement with correction using mediator mobility t_mob as an indicator of oxygen carrying capacity.
Hematocrit-based blood/control processing in a meter
A meter for measurement of an analyte in a sample, wherein the sample is either a blood sample or a control sample, and the meter comprises a programmed microprocessor configured to determine hematocrit in the sample and to process the sample as either a blood sample or a control sample depending on the result of the hematocrit determination.
Hematocrit evaluation and calibration/display based on blood versus control
A method for evaluating a sample, wherein the sample is either a blood sample or a control sample, including determining the hematocrit of the sample, and measuring an analyte amount in the sample such that the sample is treated as a control sample if the hematocrit is below a threshold level and the measured amount of analyte is used for calibration purposes, and the sample is treated as a blood sample if the hematocrit is above the threshold value, and the measured amount of analyte is displayed to a user.
The independent claim coverage is directed to using a hematocrit determination to select whether the sample is treated as blood or control, coupled with an analyte measurement workflow that includes calibration use for control samples and corrected analyte handling supported by mediator mobility t_mob linked to oxygen carrying capacity.
Stated Advantages
Compensates oxygen effects in the electrochemical analyte determination by using an additive correction factor associated with oxygen carrying capacity.
Supports correcting a raw or uncorrected analyte concentration using an additive correction equation based on mediator mobility t_mob and related parameters.
Provides classification of a sample as blood or control based on hematocrit determination.
Displays the measured amount of analyte to a user after processing based on hematocrit.
Documented Applications
Electrochemical measurement of an analyte, including glucose, in either a blood sample or a control sample, with hematocrit determination used to classify the sample and to calibrate when treated as a control.
Blood-vs-control evaluation and hematocrit-related analysis in an electrochemical meter/test strip architecture that supports dynamic switching from amperometric mode to potentiometric mode based on mediator mobility and potential-decay timing.
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