Lifescan Corporation

Usf Filtration & Separations Group Inc.

Universal Biosensors Pty Limited

Alastair McIndoe Hodges

Thomas William Beck

Oddvar Johansen

Ronald Christopher Chatelier

Ian Andrew Maxwell

Maria Teodorczyk

Santhanagopalan Nandagopalan

Garry Chambers

Timothy J Ohara

Dennis Rylatt

Remedios Dato

Bruce Verity

Remy Dato

Disclosed herein are methods and devices for detecting the presence of an analyte of interest. A biosensor device can include a reaction chamber and an electrochemical detection chamber. The reaction chamber can include at least one immobilized binding site and a probe conjugate adapted to bind to at least one of the target analyte and the immobilized binding site while the detection chamber can include electrodes for detecting an electrochemical reaction. If present, the target analyte in the fluid sample results in a change in the amount of probe conjugate bound in the reaction chamber, which can be detected electrochemically in the detection chamber.

Biosensor apparatus and methods of use

Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Electrochemical cell

Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.

System and method for measuring an analyte in a sample

Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

Systems and methods for discriminating control solution from a physiological sample

Disclosed herein are methods and apparatus for determining analyte concentration in a rapid and accurate manner. The methods include depositing a physiological sample in an electrochemical cell and finding a first and second current transient. Peak current values are obtained from the first and second peak current values and used to reduce the influence of interferents in a current value. Based on this 'corrected' current value, an accurate analyte concentration can be determined.

Methods and apparatus for analyzing a sample in the presence of interferents

A hollow electrochemical cell is provided. In one exemplary embodiment, a hollow electrochemical cell includes two sets of electrodes and an opening for admitting an analyte to the cell. At least one of the two sets of electrodes can be in fluid communication with the opening. Further, a first set of electrodes can include a working electrode spaced from a counter or counter/reference electrode by less than 500 &#x3bc;m one embodiment the working and counter or counter/reference electrodes are not co-planer. In another embodiment the working and counter or counter/reference electrodes are of substantially corresponding area. In yet another embodiment the working and counter or counter/reference electrodes are spaced from 100 to 200 &#x3bc;m apart. The first set of electrodes and the second set of electrodes can be spaced apart by greater than about 500 &#x3bc;m. Other embodiments of a hollow electrochemical cell are also provided, as are several embodiments of a glucose sensor.

A method for determining the concentration of a reduced or oxidized form of a redox species is provided. In one exemplary embodiment, an electrochemical apparatus is provided in which the apparatus includes a hollow electrochemical cell for measuring a concentration of glucose in a blood sample, a current of the cell is measured, and a concentration of a redox mediator is determined, at least in part from, a measured current of the cell. The hollow electrochemical cell can include at least one non-metal working electrode, at least one counter electrode or counter/reference electrode, and a spacer interposed between the working electrode and the counter or counter/reference electrode. In one embodiment the working electrode and the counter or counter/reference electrode are not co-planer and are separated by a distance of from about 20 microns to about 200 microns. In another embodiment the working electrode and the counter or counter/reference electrode are not co-planer and the cell has an effective cell volume of less than 1.5 microliters.

This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.

There is disclosed a method of measuring formation of a barrier to restrict or reduce movement of an electroactive species. The method comprises providing an electrochemical cell having a working electrode and a counter electrode spaced from the working electrode, providing a subject component, a testing component and at least one electroactive species within the cell, the subject and testing components being intended to cause the formation of a barrier to restrict or reduce movement of an electroactive species, applying a potential between the working electrode and the counter electrode sufficient to produce a current proportional to the concentration of the electroactive species being measured, and measuring the current at the working electrode to obtain a measure of the formation of the barrier to restrict or reduce movement of the electroactive species.

Methods of measuring barrier formation

The present invention provides a metal electrode stabilized by a coating, the coating comprising a sulfur containing moiety in its molecular structure. The coating may also include a hydrophilic group and a spacer between the sulfur containing moiety and the hydrophilic group. Preferably, the sulphur-containing moiety is selected from the group comprising thiol, disulphide and SOx, and the hydrophilic group is selected from the group comprising hydroxyl, amine, carboxyl, carbonyl, oligo (ethylene oxide) chain, and zwitterionic species. Compounds useful in the present invention include 2-mercaptoethanol, 2-mercaptoethylamine, 3-mercaptopropionic acid, thiophene, 4-carboxythiophene, cysteine, homocysteine, and cystine.

Sensor with improved shelf life

Mediator stabilized reagent compositions and methods for their use in electrochemical analyte determination assays are provided. The subject reagent compositions include an enzyme, a redox mediator and a mediator-stabilizing buffer. Optionally, the reagent compositions may further include one or more of a wetting agent, detergent, enzyme cofactor and combinations thereof. Also provided are electrochemical test strips that include the subject reagent compositions, systems and kits that include the same as well as methods for using the same in analyte detection assays. The subject invention finds use in a variety of different applications, including glucose concentration determination applications.

Mediator stabilized reagent compositions and methods for their use in electrochemical analyte detection assays

A biosensor for use in determining a concentration of a component in an aqueous liquid sample is provided including: an electrochemical cell having a first electrically resistive substrate having a thin layer of electrically conductive material, a second electrically resistive substrate having a thin layer of electrically conductive material, the substrates being disposed with the electrically conductive materials facing each other and being separated by a sheet including an aperture, the wall of which aperture defines a cell wall and a sample introduction aperture whereby the aqueous liquid sample may be introduced into the cell; and a measuring circuit.

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Blackburn South, Australia

Alastair McIndoe Hodges