Roche Diabetes Care, Inc.

Bayer Healthcare LLC

Ascensia Diabetes Care Holdings Ag

F. Hoffmann-la Roche Ag

Scott E Carpenter

Zheng Zheng Pan

Harvey B Buck, Jr

Terry Allen Beaty

Rene Valverde-Ventura

Huan-Ping Wu

Thomas P Benson

Nigel A Surridge

Abner D Joseph

Christine D Nelson

Harvey Buck

Randall K Riggles

Georgeta C Lica

Siva Chittajallu

Theresa A Rey

Harvey E Buck, Jr

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods allow one to correct and/or compensate for confounding variables such as hematocrit, salt concentration and/or temperature before providing an analyte concentration. The measurement methods use response information from a test sequence having at least one DC block, where DC block includes at least one excitation pulse and at least one recovery pulse, and where a closed circuit condition of an electrode system is maintained during the at least one recovery pulse. Information encoded in the excitation and recovery pulses are used to build within- and across-pulse descriptors to correct/compensate for hematocrit, salt concentration and/or temperature effects on the analyte concentration. Methods of transforming current response data also are disclosed. Further disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Descriptor-based methods of electrochemically measuring an analyte as well as devices, apparatuses and systems incorporating the same

A biosensor including a capillary chamber having an inner boundary, a working electrode including an effective working electrode portion positioned within the capillary chamber, and a counter electrode including an effective counter electrode portion positioned within the capillary chamber, and with the working and counter electrodes each having a neck that constitutes the sole portion of the electrodes that extends across the inner boundary and out of the capillary chamber. In one embodiment, the effective working electrode portion defines an average working electrode width, and the working electrode neck defines a working electrode neck width that is reduced relative to the average working electrode width. In another embodiment, a ratio between the area of the effective working electrode portion exposed to the capillary chamber and the area of the effective counter electrode portion exposed to the capillary chamber is substantially constant as a position of the inner boundary of the capillary chamber is varied along a length of the working and counter electrode necks.

Electrode configuration for a biosensor

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods further allow one to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature or both before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one AC block and at least one pulsed DC block, where pulsed DC block includes at least one recovery potential, and where a closed circuit condition of the electrode system is maintained during the DC block. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Methods of electrochemically measuring an analyte with a test sequence having a pulsed DC block as well as devices, apparatuses and systems incorporating the same

Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

Methods of scaling data used to construct biosensor algorithms as well as devices, apparatuses and systems incorporating the same

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods allow one to correct and/or compensate for confounding variables such as temperature before providing an analyte concentration. The measurement methods use response information from a test sequence having at least one DC block, where the DC block includes at least one excitation pulse and at least one recovery pulse, and where a closed circuit condition of an electrode system is maintained during the at least one recovery pulse. Information encoded in the at least one recovery pulse is used to correct/compensate for temperature effects on the analyte concentration. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Methods of using information from recovery pulses in electrochemical analyte measurements as well as devices, apparatuses and systems incorporating the same

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods further allow one to provide an error code or correct and/or compensate for interferents such as an antioxidant before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one DC block, such as a slow-ramped bi-polar waveform, where a closed circuit condition is maintained during the DC block. The methods use information relating to status of a redox mediator feature during the electrochemical analysis to provide an antioxidant failsafe if the antioxidant is interfering with the analyte concentration. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Methods of detecting high antioxidant levels during electrochemical measurements and failsafing an analyte concentration therefrom

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods further allow one to provide an error code or correct and/or compensate for interferents such as an antioxidant before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one DC block, where DC block includes at least one recovery potential, and where a closed circuit condition of the electrode system is maintained during the DC block. The methods use information relating to status of a redox mediator during the electrochemical analysis to provide a statistical antioxidant failsafe using either a classifier or a discriminator to determine whether the antioxidant is interfering with the analyte concentration. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Methods of failsafing electrochemical measurements of an analyte as well as devices, apparatuses and systems incorporating the same

A biosensor has an abnormal output detection system that determines whether an output signal from the redox reaction of an analyte has a normal or abnormal shape or configuration. The abnormal output detection system improves the accuracy and precision of the biosensor in determining whether an output signal has a shape or configuration that may not provide an accurate and/or precise analysis of a biological fluid. The biosensor generates an output signal in response to the redox reaction of the analyte. The biosensor normalizes the output signal and compares the normalized output signal with one or more control limits. The biosensor may generate an error signal when the normalized output signal is not within the control limits.

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Pendleton, IN, United States of America

Scott E Carpenter