Bayer Healthcare LLC

Ascensia Diabetes Care Holdings Ag

Miles Inc.

Bayer Corporation

Amy H Chu

Huan-Ping Wu

Andrew J Edelbrock

Steven C Charlton

Dijia Huang

Sung-Kwon Jung

Mary Ellen Warchal-Windham

Karen L Marfurt

Boru Zhu

Douglas E Bell

Hope Spradlin

Brenda L Tudor

Kin F Yip

Michael J Wilcox

Kin-Fai Yip

Yingping Deng

Howard A Cooper

Lon R Stover

Brenda Tudor

Wei-Sen Chu

Hope G Spradlin

A reagent for detecting an analyte comprises a flavoprotein enzyme, a mediator such as a phenothiazine mediator, at least one surfactant, a polymer and a buffer. The reagent may be used with an electrochemical test sensor that includes a plurality of electrodes.

Reagents and methods for detecting analytes

A biosensor system determines an analyte concentration of a biological sample using an electrochemical process without Cottrell decay. The biosensor system generates an output signal having a transient decay, where the output signal is not inversely proportional to the square root of the time. The transient decay is greater or less than the &#x2212;0.5 decay constant of a Cottrell decay. The transient decay may result from a relatively short incubation period, relatively small sample reservoir volumes, relatively small distances between electrode surfaces and the lid of the sensor strip, and/or relatively short excitations in relation to the average initial thickness of the reagent layer. The biosensor system determines the analyte concentration from the output signal having a transient decay.

Determining analyte concentration from variant concentration distribution in measurable species

A biosensor system for determining the concentration of an analyte in a sample includes a plurality of test sensors, and includes a container including a desiccant and the plurality of test sensors, sealed in the container. When the container is stored for two weeks at a temperature of 50&#xb0; C., and each test sensor is subsequently removed from the container, connected through the at least two conductors to a measurement device and then contacted with one of a plurality of samples including an analyte, where the plurality of samples has analyte concentrations that span the range of 50 mg/dL-600 mg/dL, and the analyte concentration in each sample is determined by the test sensor and the measuring device, the bias of each determined analyte concentration may be within &#xb1;10 mg/dL or &#xb1;10%, and the coefficient of variation of the determined analyte concentrations may be at most 2.5%.

Biosensor desiccant system having enhanced measurement performance

Transient decay amperometry biosensors

A test sensor reagent for measuring the concentration of analytes in body fluids includes cellulose polymers for improving the stability of the test sensor and reducing the total assay time. The test sensor reagent also includes an enzyme, an electron transfer mediator and a rheological additive.

Test sensor reagent having cellulose polymers

A reagent composition containing GDH-PQQ as an enzyme-co-factor and screen-printed on working and counter electrodes of electrochemical biosensors, maintains activity of the enzyme reagents by proper selection of components. A preferred composition includes hydrophilic polymers, amorphous untreated silica, buffers, surfactants, and a mediator. For example, the biosensor is useful in the amperometric determination of glucose.

Reagent composition for electrochemical biosensors

A biosensor system for determining the concentration of an analyte in a sample is disclosed that includes a reaction means for selectively performing a redox reaction of an analyte, and a measurement means for measuring a rate of the redox reaction of the analyte. The reaction means includes a binder, a buffer salt, a mediator including at most 20% (w/w) of an inorganic, non-transition metal salt, and an enzyme system. The measurement means includes at least two conductors. The measurement means measures an output signal value from the reaction means at a maximum kinetic performance within at most 7 seconds of introducing a sample to the reaction means, where the output signal value is responsive to the concentration of the analyte in the sample, and the measurement means determines at least one &#x394;S value responsive to at least one error parameter. The measurement means further determines the analyte concentration in the sample from a compensation equation including at least one reference correlation and the at least one &#x394;S value, where the compensation equation has a Rvalue of at least 0.5.

Low total salt reagent compositions and systems for biosensors

Transient decay amperometry

A method of determining the concentration of an analyte in a fluid test sample that includes providing an electrochemical sensor adapted to measure the analyte in the test sample. The test sample sufficiently covers a counter and working electrode of the electrochemical sensor. A first potential is applied between the counter and working electrodes for a first predetermined time period and the current is measured and the time is recorded. After the first potential is removed or substantially reduced, a second potential is applied between the counter and working electrodes and the current is measured. The concentration of the analyte is determined in the test sample as a function of the current measured. An index is calculated and compared to at least one predetermined parameter to identify when a bias, if any, exceeds a threshold. An error signal or analyte concentration is displayed depending on the comparison.

Methods of determining the concentration of an analyte in a fluid test sample

The present invention provides a device and a process for detecting an analyte in a biological fluid. The device comprises a separating matrix for separating analyte from the fluid and means for detecting the analyte, where the separating matrix contains HEPES buffer, preferably in an amount between 70 and 150 millimolar. The process comprises applying the sample to the device having a separating matrix and then detecting analyte in the sample using the detection means. The presence of HEPES in the separation layer shortened the detection time.

Analyte detection device and process

Disclosed is an improvement to the method for the detection of creatinine in which creatinine, in aqueous solution, is contacted with a dry reagent system of an indicator for creatinine. The assay is carried out at a pH above about 11.5 which is maintained by an alkaline material. The improvement involves packaging the reagent system with a material capable of absorbing CO.sub.2 and at least some ambient water vapor. This inhibits the formation of carbonic acid thereby reducing the neutralization of the alkaline reagent system during storage to increase the shelf life and decrease the variability of the system.

Use of CO.sub.2 absorbant for stabilization of dried alkaline reagent in

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Elkhart, IN, United States of America

Amy H Chu