Lifescan Corporation

Technicon Instruments Corporation

University of California

Miles Inc.

Bayer Corporation

Koon-Wah Leong

Bronislaw P Czech

Eddy Chapoteau

Anand Kumar

Carl R Gebauer

Ernest J Kiser

Donald J Cram

Roger C Helgeson

Robert Justice Shartle

Maria Teodorczyk

John Christopher Davis

John Mahoney

Caroline Chu

Herb Perasso

Susan Tannenbaum

Janice Jones

Lorin Philip Olson

Sherry Guo

Devin McAllister

Vadim V Yuzhakov

Yeung Siu Yu

Jerry Thomas Pugh

Arjuna Ragunath Karunaratne

Suyue Qian

Edward G Rice

Stanford L Adler

Remedios Dato

Jonathan Craine

Shery Guo

John Campisi

Jose I Fernandez

Oscar Raimondo

Ranga R Vunnam

Ernest Kiser

Arjuna Karunaratne

Jerry T Pugh

Devin Mcallister

A method of manufacturing an analyte test strip includes positioning a patterned spacer layer between a first insulating layer and a second insulating layer such that the second insulating is disposed above the first insulating layer and a channel is defined between the first and second insulating layers. Moreover, the channel thus defined has a sample-receiving chamber therein, a first port, and a second port. The method also includes coupling a third insulating layer to the first insulating layer such that the third insulating layer is disposed at least partially below the first insulating layer. In the coupling step, the third insulating layer includes a platform portion that extends beyond the first insulating layer and the second insulating layer and the platform portion has an upper surface. In this manufacturing method, the first and second ports are in fluidic communication with the sample-receiving chamber; the upper surface of the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and for filling the sample-receiving chamber with a portion of the first bodily fluid sample, and the second port is configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and for filling the sample-receiving chamber with a portion of the small bodily fluid sample.

Method of manufacturing analyte test strip for accepting diverse sample volumes

A method for determining (e.g., detecting and/or measuring the concentration of) an analyte in a bodily fluid sample includes obtaining a bodily fluid sample, applying the bodily fluid sample to an analyte test strip, transferring the applied bodily fluid sample to a sample-receiving chamber of the analyte test strip, and determining an analyte in the bodily fluid sample. The analyte test strip employed in the method includes a first port in fluidic communication with the sample-receiving chamber and proximate a platform portion of the analyte test strip. Moreover, the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port. The analyte test strip also includes a second port in fluidic communication with the sample-receiving chamber and an outer edge of the analyte test strip, the second port configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and for transferring at least a portion of the second bodily fluid sample to sample-receiving chamber. In addition, the applying step involves applying the bodily fluid sample to one of the second port and the platform portion of the analyte test strip depending on the volume of the bodily fluid sample.

Method for determining an analyte in a bodily fluid

A method for determining an analyte in a bodily fluid sample includes inserting the analyte test strip into a test meter. The insertion is such that an electrical connector pin of the test meter travels along an electrical contact pad of the analyte test strip, and across a meter identification feature disposed on the electrical contact pad, during the insertion. Moreover, during the insertion, a signal processing module of the test meter measures an electrical characteristic via the electrical connector pin as the electrical connector pin travels along the electrical contact pad and across the meter identification feature. The method also includes identifying the analyte test strip, using the signal processing module, based on the electrical characteristic measured as the analyte test strip is inserted into the test meter and, thereafter, applying the bodily fluid sample to the analyte test strip upon notification by the test meter that the identification indicates that such applying is appropriate. The method then includes determining an analyte in the bodily fluid sample using the test meter only if the identification indicates that such determining is appropriate. The electrical contact pad of the analyte test strip employed in the method has a predetermined contact electrical characteristic value and the meter identification feature of the analyte test strip has a predetermined identification feature electrical characteristic value that is dissimilar from the predetermined contact electrical characteristic, thus providing for identification of the analyte test strip by the test meter.

Method for determining an analyte in a bodily fluid sample using an analyte test strip with combination electrode contact and meter identification feature

Methods of auto-calibrating a meter are disclosed. In one aspect, the method can include determining a set of calibration information applicable to a sensor and storing the calibration information onto a tag element associated with a sensor dispenser. The tag element can be placed into communication with a reader element that is associated with a meter and which is configured to receive the calibration information so as to allow the meter to use the calibration information in a calibration procedure. Various aspects of a system for auto-calibrating a meter are also disclosed.

Auto-calibrating metering system and method of use

An analyte, system, strip and method are described. In one example, an analyte test strip is provided that includes a substrate, electrically conductive material and an isolated portion of the electrically conductive material. The substrate has a generally planar surface that extends from a first end to a second end. The electrically conductive material is disposed on the generally planar surface to define a plurality of electrodes spaced apart from each other. The isolated portion of the electrically conductive material is disposed between at least two electrodes so that the isolated portion is not in electrical communication with the plurality of electrodes.

Analyte test strip with improved reagent deposition

An analyte test strip for accepting diverse bodily fluid sample volumes includes a first insulating layer, a second insulating layer disposed above the first insulating layer, and a third insulating layer disposed below the first insulating layer. The third insulating layer has a platform portion that extends beyond the first and second insulating layers and an upper surface. The analyte test strip also has a patterned spacer layer positioned between the first and second layers. The patterned spacer layer defines a channel between the first and second insulating layers that has a sample-receiving chamber, a first port proximate the platform portion and a second port at an outer edge of the analyte test strip. Moreover, the first port and the second port are in fluidic communication with the sample-receiving chamber. In addition, the upper surface of the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port. The second port is configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and to transfer at least a portion of the second bodily fluid sample to the sample-receiving chamber.

Analyte test strip for accepting diverse sample volumes

A device for accessing biological fluid, sampling biological fluid constituents and determining the concentration of at least one target constituent within the accessed biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and to access biological fluid, a constituent sampling means and a constituent measuring means. The constituent sampling means comprises a constituent transfer medium, such as a hydrophilic gel material, by which sampled constituents are transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode through which at least one sampled constituent is caused to enter into the electrochemical cell. Methods of sampling constituents within the skin and measuring the sampled constituents, as well as kits for practicing the invention are provided.

Biological fluid constituent sampling and measurement devices

Methods and devices for electrochemically detecting a change in the viscosity of a fluid are provided. In the subject methods, a fluid sample (e.g., a whole blood sample) is introduced into an electrochemical test strip's electrochemical cell using a micro-needle integrated into one of oppositely spaced apart working and reference electrodes. An electric potential is applied to the electrochemical cell to first achieve a steady state cell current. A decrease in the steady state cell current is then detected and related to a change in viscosity of the sample. In many embodiments, the sample is blood and the change in viscosity is related to the onset of coagulation in the blood sample, and often the PT of the blood sample. An electrochemical test strip includes an electrochemical cell and an integrated micro-needle. The electrochemical cell includes oppositely spaced apart working and reference electrodes and a reagent mixture (e.g., a redox couple and a coagulation catalyzing agent). The micro-needle is integrated into one of the working and reference electrodes of the electrochemical cell.

Electrochemical test strip with an integrated micro-needle and associated methods

Methods of fabricating devices for collecting a sample of physiological and for measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. The fabrication methods provide various or forming the test strip and the skin-piercing element.

Methods of fabricating physiological sample collection devices

Compositions, methods, devices and kits utilizing water-based hydrophilic coating formulations on medical implements. The composition for applying a coating comprises a sulfonated polyester, water, and a surface active agent. Methods for coating a medical implement comprise providing an aqueous dispersion comprising sulfonated polyester and surface active agent, contacting the medical implement with the aqueous dispersion, and drying the medical implement. Methods for acquiring a sample of bodily fluid from a patient comprise coating a needle with a sulfonated polyester, penetrating the needle into the patient, and drawing bodily fluid through the needle.

Hydrophilic coatings for medical implements

A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned co-axially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive devices and/or systems.

Percutaneous biological fluid sampling and analyte measurement devices and methods

Compositions, reagent test strips, analyte detection systems and kits of the same, as well as methods for their use in the detection of an analyte in a sample, are provided. The subject compositions are characterized by having a positively charged porous matrix and a urea derivative dye on at least one surface of the matrix, where in many preferred embodiments the urea derivative dye is a negatively charged urea derivative dye. In many preferred embodiments, the subject compositions further include at least one additional reagent member of a peroxide producing signal producing system, e.g., an analyte oxidase and/or a peroxidase. The subject compositions, test strips, analyte detection systems and kits find use in the detection of a wide variety of analytes in a sample, such as a physiological sample, e.g., blood or a fraction thereof.

Compositions containing a urea derivative dye for detecting an analyte and methods for using the same

Multilayer reagent test strips for quantitating glycated protein in a fluid sample, as well as methods for using the same, are provided. The subject multilayer test strips include at least a filter layer, a proteinase layer and a ketoamine oxidase signal producing and fluid flow control system layer. In using the subject test strips, a fluid sample is applied to the test strip and a signal is generated that can be employed to quantitate the glycated protein level in the sample. The quantitated glycated protein level can then be employed to determine the amount of glycated protein in the fluid sample. Also provided are kits and systems that include the subject test strips and find use in practicing the subject methods. The subject compositions and methods find use in glycated protein monitoring applications, among other utilities.

Multilayer reagent test strips to quantify glycated protein in a physiological sample

The present invention includes devices, systems and methods for containing and using liquid solutions. The devices include liquid containment structures and packages of such liquid containment structures for containing single doses of a liquid solution for subsequent use. The systems include at least one subject containment structure or package of containment structures and the liquid solution for which they are intended to contain. The liquid solutions may comprise any type of agent, reagent or control solution. The subject methods involve the use of the liquid containment structures and packages thereof as well as methods of providing a control solution for use to evaluate a system's performance.

Devices, systems and methods for the containment and use of liquid solutions

Biological fluid constituent sampling and measurement devices and methods

Growing community of inventors

Sunnyvale, CA, United States of America

Koon-Wah Leong