Lifescan Scotland Limited

Lifescan IP Holdings, LLC

Cilag International Gmbh

David McColl

Antony Smith

Lynsey Whyte

Neil Whitehead

Michael Malecha

Stephen Mackintosh

Scott J Sloss

Zuifang Liu

Mandip Farmahan

Robert Donald

Anna Salgado

David Elder

Brian Guthrie

Rossano Claudio Massari

Marco Fabio Cardosi

David Morris

Adam Craggs

Gavin Macfie

Allan Macrae

Christian Fabio Forlani

Steve Blythe

Alexander Cooper

Timothy Lloyd

Raymond Welsh

Joanne Watt

Prasanta Pati

Ryan Magennis

A method for determining a concentration of an analyte in a fluidic sample is described. A sample is applied to a biosensor including an electrochemical cell having electrodes. A predetermined voltage waveform is applied during at least first and second time intervals. At least first and second current values are measured during the first and second time intervals, respectively. A turning point time is determined during the first time interval at which the measured first current values transition from a first to a second profile. The concentration of analyte in the sample is calculated based on determined turning point time and at least one measured current value. In another example, a physical characteristic of the sample is estimated based on measured current values. The concentration is calculated using a first or second model if the estimated physical characteristic of the sample is in a first or second range, respectively.

Method for determining analyte concentration in a sample

A method for determining contamination of a biosensor in which the biosensor is loaded into a test meter and a sample is then applied. First and second predetermined test voltages are applied between spaced electrodes of the biosensor for respective first and second predetermined time intervals. First and second current values are measured during the respective first and second predetermined time intervals. Reference values are determined based on the measured first and second current values. Based on one or more of the reference values, a determination of contamination is made. Reporting of the analyte concentration of the sample can be suppressed based on the determination.

Contamination determination of biosensors used in analyte measurement systems

Various embodiments for methods and systems that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic of the sample containing the analyte and deriving one of a batch slope, sampling time, or combinations thereof to attain accurate glucose concentration.

Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte

Method for determining analyte concentration in a sample technical field

Various embodiments for a method that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic, typically hematocrit, of the sample containing the analyte and deriving from this characteristic a parameter relating to the biosensor to attain accurate glucose concentration.

Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte and derived biosensor parameters

A system for determining usability of an analytical test strip includes a sample chamber to receive a fluid sample, a reagent in the sample chamber having a moisture-varying impedance, and two detection electrodes contacting the reagent. A test meter applies an AC waveform across the reagent via the detection electrodes while measuring an impedance of the reagent. A processor automatically determines whether the measured impedance of the reagent meets a dryness criterion. The meter includes a housing, a strip port connector, an impedance measurement circuit and the processor. A method for determining usability of a strip inserted in a hand held meter includes applying an AC waveform across a reagent of the strip and measuring a first electrical signal, and determining whether the strip meets the dryness criterion based on the first electrical signal. The test strip and ways of determining an analyte are also described.

Determining usability of analytical test strip

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. The methods and systems describe herein allow for trapping various errors during calculation of the analyte due to variations in the structure and materials making up the test strip and ambient temperatures.

Analyte measurement method and system with error trapping

An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Analytical test strip with capillary sample-receiving chambers separated by a physical barrier island

Analyte test strip design

An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (e.g., hematocrit) includes a sample-entry chamber with a sample-application opening disposed on an end edge of the electrochemical-based analytical test strip, and first and second sample-determination chambers, each in direct fluidic communication with the sample-entry chamber. The electrochemical-based analytical test strip also includes first and second electrodes (such as first and second hematocrit electrodes) disposed in the first sample-determination chamber, and a third and fourth electrodes (for example working and reference electrodes) disposed in the second sample-determination chamber. Moreover, the first and second sample-determination chambers intersect the sample-entry chamber perpendicular (or nearly perpendicular) to one another and the first sample-determination chamber also intersects the sample-entry chamber in an aligned manner.

End-fill electrochemical-based analytical test strip with perpendicular intersecting sample-receiving chambers

Two techniques of determining hematocrit using impedance and phase angle to determine hematocrit are shown and described for correcting an analyte concentration.

Hematocrit corrected glucose measurements using phase angles and impedance for electrochemical test strip

Various embodiments that allow for determination of hematocrit by a time differential between the input and output signals such that a glucose measurement for a blood sample can be corrected by the measured hematocrit of the blood sample.

Hematocrit corrected glucose measurements for electrochemical test strip using time differential of the signals

An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (for example, hematocrit) includes a first sample-receiving chamber with first and second sample-application openings, and first and second electrodes. The first and second electrodes are disposed in the first sample-receiving chamber between the first and second sample-application openings. The electrochemical-based analytical test strip also includes a second sample-receiving chamber and a plurality of electrodes disposed in the second sample-receiving chamber. In addition, the second sample-receiving chamber intersects the first sample-receiving chamber between the first and second electrodes, thereby defining a chamber intersection.

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Inverness, United Kingdom

David McColl