Lifescan Scotland Limited

Lifescan Corporation

Marco Fabio Cardosi

Christopher Philip Leach

Leanne Mills

Stephen Patrick Blythe

Emma Vanessa Jayne Day

Richard Michael Day

James Iain Rodgers

Selwayan Saini

Thomas Rangi Sutton

Gretchen Anderson

Steven John Setford

James T Moffat

Eric Jason Bailey

Mary McEvoy

Gavin Macfie

Graeme J Webster

Lorraine Comstock

Nina Antonia Naylor

Arlene Thompson

Matthew Finch

Andrew Gill

David McColl

Manuel Alvarez-Icaza

Zuifang Liu

Geoffrey Lillie

Stephen Mackintosh

Adam Craggs

Michael O'Connell

Steve Blythe

Michael Patick Dolan

Chris Leach

Michael Patrick Dolan

Described and illustrated herein are one exemplary method and a measurement system having a meter and a test strip. The test strip has a first working electrode, reference electrode and second working electrode. In this method, acceptable fill data from known first current and known second current are used to predict an estimated second current at proximate the second time period (for a given batch of test strips) during the test sequence. The estimated second current at proximate the second time interval is then compared with a measured actual second current at proximate the second time interval during an actual test to determine if the measured actual second current is substantially equal to or within an acceptable percent deviation from the estimated second current so as to determine sufficient volume of a physiological fluid sample in the test strip.

Fill sufficiency method and system

The method includes: providing a test strip comprising a reference electrode and a working electrode coated with a reagent layer; applying a fluid sample to the test strip for a reaction period; applying a test voltage between the reference electrode and the working electrode; measuring a test current as a function of time; measuring a steady state current value when the test current has reached an equilibrium; calculating a ratio of the test current to the steady state current value; plotting the ratio of the test current to the steady state current value as a function of the inverse square root of time; calculating an effective diffusion coefficient from the slope of the linearly regressed plot of the ratio of the test current to the steady state current value as a function of the inverse square root of time; and calculating a hematocrit-corrected concentration of analyte.

Method for determining hematocrit corrected analyte concentrations

A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

Systems and methods for determining a substantially hematocrit independent analyte concentration

A test meter for use with a dual-chamber, multi-analyte test strip includes a test strip receiving module and a signal processing module. The test strip receiving module has a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the test strip; a second electrical connector configured for contacting a second analyte contact pad of a second working electrode of the test strip, a third electrical connector configured for contacting a first counter/reference contact pad of a first counter/reference electrode layer of the test strip, and a fourth electrical connector configured for contacting a second counter/reference contact pad of a second counter/reference electrode layer of the test strip. The signal processing module is configured to receive a first signal via the first electrical connector and the third electrical connector and employ the first signal for the determination of a first analyte (such as glucose) in a bodily fluid sample (for example, whole blood sample) applied to the dual-chamber, multi-analyte test strip. Moreover, the signal processing module is also configured to receive a second signal via the second electrical connector and fourth electrical connector and employ the second signal for the determination of a second analyte (e.g., a ketone analyte) in the bodily fluid sample applied to the dual-chamber, multi-analyte test strip. Furthermore, the third and fourth electrical contacts provide contact in an opposing manner.

Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes

Described and illustrated herein are systems and exemplary methods of operating a multianalyte measurement system having a meter and a test strip. In one embodiment, the method may be achieved by applying a test voltage between a reference electrode and a first working electrode; measuring a first test current, a second test current and a third test current at the working electrode with the meter after a blood sample containing an analyte is applied to the test strip; estimating a hematocrit-corrected analyte concentration from the first, second and third test currents; and displaying the hematocrit-corrected analyte concentration.

Analyte measurment method and system

Described herein is an electrochemical enzymatic analyte test strip and method for making the test strip. The test strip utilizes isolated conductive areas inside the electrodes to define electrode whiskers. The method utilizes laser ablation to define electrode patterns.

Test strip comprising patterned electrodes

A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.

Methods for determining an analyte concentration using signal processing algorithms

Description is provided herein for an embodiment of a method determining a hematocrit-corrected glucose concentration. The exemplary method includes providing a test strip having a reference electrode and a working electrode, wherein the working electrode includes a plurality of microelectrodes and is coated with at least an enzyme and a mediator. The method can be achieved by: providing a test strip comprising a reference electrode and a working electrode formed with a plurality of microelectrodes and coated with a reagent layer; applying a fluid sample to the test strip for a reaction period; applying a test voltage between the reference electrode and the working electrode; measuring a test current as a function of time; measuring a steady state current value when the test current has reached an equilibrium; calculating a ratio of the test current to the steady state current value; plotting the ratio of the test current to the steady state current value as a function of the inverse square root of time; calculating an effective diffusion coefficient from the slope of the linearly regressed plot of the ratio of the test current to the steady state current value as a function of the inverse square root of time; and calculating a hematocrit-corrected concentration of analyte.

A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer. The second patterned spacer layer has a second sample-receiving chamber, with first and second end openings, defined therein. The test strip additionally has a second electrically conductive layer, with a second working electrode, disposed above the second patterned spacer layer, a second insulating layer disposed above the second electrically conductive layer, a first analyte reagent layer disposed on the first working electrode within the first sample-receiving chamber; and a second analyte reagent layer disposed on the second working electrode within the second sample-receiving chamber. The second counter/reference electrode layer is exposed to the second sample receiving chamber and is in an opposing relationship to the second working electrode.

Dual chamber, multi-analyte test strip with opposing electrodes

A method for manufacturing an enzymatic reagent ink for use in analytical test strips (such as electrochemical-based analytical test strips configured for the determination of glucose in blood) includes determining a first relationship between wetability of a representative hydrophobic silica material (e.g., a hydrophobic fumed silica material) and at least a first calibration characteristic (for example, a calibration slope) of an analytical test strip that includes an enzymatic reagent ink containing the representative hydrophobic silica material. In the method, the first relationship defines a minimum wetability that provides an acceptable first calibration characteristic. The method also includes determining a second relationship defining wetability of a mixture of a particular hydrophobic silica material and a particular surfactant across a range of relative amount of the particular hydrophobic silica material and the particular surfactant and, subsequently, combining an amount of the particular hydrophobic silica material, an amount of the particular surfactant, and an amount of enzyme (such as glucose oxidase) to form an enzymatic reagent ink. Moreover, the amounts of the particular hydrophobic silica material and the particular surfactant are predetermined based on the second relationship to provide at least the minimum wetability defined by the first relationship.

Method for manufacturing an enzymatic reagent ink

A system for the determination of an analyte in a bodily fluid sample includes an analytical test strip and an analytical meter. The analytical test strip has a substrate layer, an electroluminescent component (either an electroluminescent module and/or an electroluminescent lamp) disposed on the substrate layer, and a sample chamber configured for receiving a bodily fluid sample disposed above the substrate layer. Moreover, the analytical meter is configured for insertion of the analytical test strip therein and subsequent determination of the analyte.

System for determination of an analyte in a bodily fluid sample that includes an electroluminescent component

Ionic hydrophilic high molecular weight redox polymers for use in enzymatic electrochemical-based sensors include a hydrophilic polymer (such as a hydrophilic polymer backbone) with ionic portions (e.g., cationic monomers incorporated in the hydrophilic polymer backbone) and a plurality of attached redox mediators. The redox mediators can be, for example, covalently attached to the hydrophilic polymer in a pendant manner. An exemplary cationic hydrophilic high molecular weight redox polymer is synthesized by co-polymerization of a hydrophilic acrylamide monomer, [2-(acryloyloxy)ethyl]trimethyl ammonium chloride and vinyl ferrocene.

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Croy, United Kingdom

Marco Fabio Cardosi