Lifescan Corporation

Advanced Cardiovascular Systems, Inc.

Yeung Siu Yu

Tianmei Ouyang

Edward G Rice

Ni Ding

Charles David Claude

David P Matzinger

Mahesh Shah

Michael F Tomasco

Koon-Wah Leong

Ernest J Kiser

Xiaoling Zheng

Paing C Huang

Adva Yani

Khalid R Quraishi

John L Smith

Tahir Sadik Khan

Saker A Karimi

Steven Zweig

A polymeric composition comprising a polysulfone polymer and an elastomeric polymer for use as a coating composition for coating an implantable device, such as a DES, and methods of making and using the implantable device are provided.

Polysulfone block copolymers as drug-eluting coating material

Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a reaction zone defined by opposing metal electrodes separated by a thin spacer layer. The metal surface of at least one of the electrodes is modified by a homogenous surface modification layer made up of linear self-assembling molecules having a first sulfhydryl end group and a second sulfonate end group separated by a short chain alkyl linking group, where 2-mercaptoethane sulfonic acid or a salt thereof is preferred in certain embodiments. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of glucose.

Electrochemical test strip kit for analyte determination

A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises a flavin-dependent enzyme that has specificity for the analyte, a flavin cofactor if, and only if, a flavin is not bound to the enzyme, a tetrazolium dye precursor, an electron transfer agent, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring glucose in whole blood.

Diagnostics based on tetrazolium compounds

Test strips for determining the concentration of at least one analyte, e.g., glucose, in a physiological sample and methods for their manufacture and use and are provided. The subject test strips include a transfer element for facilitating the transfer of sample to a reaction area of the test strip. In certain embodiments, the transfer element, typically porous, has a first area and a second area, and in certain embodiments the two areas have different thicknesses. In other embodiments, the transfer element is non-porous and is configured to transfer sample by wicking it between the transfer element and the reaction area of the test strip. In the subject methods, the transport element facilitates transfers of a sample to a reaction area of the test strip. The subject test strips and methods find use in a variety of different applications, particularly in the determination of glucose concentrations.

Devices for analyte concentration determination and methods of manufacturing and using the same

Methods for making reagent test strips are provided. In the subject methods, a test strip precursor made up of an elongated support material having a planar surface and a narrow stripe of reagent material positioned along its central axis is cut according to an inter-digitating pattern to produce the plurality of reagent test strips. The initial precursor material may be a tape or in the form of a card. Also provided are the reagent test strips produced by the subject methods and kits that include the same. The subject reagent test strips and kits find use in analyte detection and/or concentration determination assays.

Methods of manufacturing reagent test strips

Test strips, and methods for their manufacture and use in the determination of the concentration of at least one analyte in a physiological sample are provided. The subject test strips have a plurality of reaction zones defined by a hydrophobic barrier. The reagent compositions present in each reaction zone may be the same or different. In addition, each reaction zone may have a separate fluid channel, or two or more of the reaction zones may have separate channels that merge into a single channel. In use, sample is applied to a subject test strip, a signal is detected and then related to the amount of analyte in the sample. Also provided are methods for manufacturing the subject test strips using thermal transfer technology to apply the hydrophobic barrier. Finally, kits are provided for use in practicing the subject methods.

Test strips having reaction zones and channels defined by a thermally transferred hydrophobic barrier

Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a reaction zone defined by opposing metal electrodes separated by a thin spacer layer. The metal surface of at least one of the electrodes is modified by a homogenous surface modification layer made up of linear self-assembling molecules having a first sulfhydryl end group and a second sulfonate end group separated by a short chain alkyl linking group, where 2-mercaptoethane sulfonic acid or a salt thereof is preferred in certain embodiments. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of gluose.

Electrochemical test strip for use in analyte determination

A reagent test strip for measuring an analyte concentration in a biological fluid has a spreading mesh sandwiched between a support and a reagent matrix. The support has a through hole that is covered by the mesh. In use, a sample of the fluid is applied through the hole in the support to the spreading mesh. The sample then passes through the mesh to the matrix, which contains a reagent that indicates the analyte concentration by causing a corresponding change in reflectance at its free surface. Optionally, an adhesive layer attaches the mesh, and optionally the matrix as well, to the support.

Multi-layer reagent test strip

Test strips and methods for their use in the detection of an analyte in a sample are provided. The subject test strips are characterized by at least including a water soluble tetrazolium salt on a surface of a positively charged substrate. In many embodiments, the water soluble tetrazolium salt is present as part of an analyte oxidizing signal producing system, which system includes one or more of the following additional components: an analyte oxidizing enzyme, e.g., an analyte dehydrogenase or an analyte oxidase; an electron transfer agent; and an enzyme cofactor. Also provided are systems and kits incorporating the subject test strips. The subject test strips, systems and kits find use in the measurement of a wide variety of analytes in a sample, such as a physiological sample, e.g., blood or a fraction thereof.

Test strips for detecting the presence of a reduced cofactor in a sample and method for using the same

8-(anilino)-1-naphthalenesulfonate (ANS) analogs and methods for their use in analyte detection assays are provided. The subject ANS analogs are characterized by having at least one non-hydrogen substituent on their phenyl moiety and producing a reaction product with 3-methyl-2-benzothiazolinone hydrazone hydrchloride (MBTH) or an analog thereof, e.g. MBTHSB, that exhibits reduced drift. In certain preferred embodiments, the subject ANS analogs are described by the formula:

8-(anilino)-1-naphthalenesulfonate analogs

A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises dehydrogenase enzyme that has specificity for the analyte, NAD, an NAD derivative, pyrrolo-quinoline quinone (PQQ), or a PQQ derivative, a tetrazolium dye precursor, a diaphorase enzyme or an analog thereof, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring ketone bodies, such as beta-hydroxybutyrate.

A reagent test strip is adapted for use in a blood glucose meter. A sample of whole blood is applied to one surface of a matrix on the strip and the meter measures the reflectance of the opposite surface of the matrix at about 635 nm and 700 nm and calculates from the reflectance the concentration of glucose in the sample. The portion of the applied sample that penetrates the matrix and is visible from the testing surface does not absorb light to any appreciable extent at 700 nm. Nevertheless, the glucose-containing sample interacts with the components of the reagent-containing matrix to cause a change in reflectance at 700 nm that simulates the effect of the blood color. As a result, the strip can be used in meters that measure glucose concentration in whole blood samples in the presence of optically visible hemoglobin.

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Pleasanton, CA, United States of America

Yeung Siu Yu