Roche Diagnostics Operations, Inc.

Roche Operations Ltd.

Boehringer Mannheim Gmbh

Roche Diabetes Care, Inc.

Roche Diagnostics Gmbh

Roche Opersations Ltd.

F. Hoffmann-la Roche Ag

Nigel A. Surridge

David W. Burke

Henning Groll

Nigel A Surridge

Eric R Diebold

David W Burke

Raghbir Singh Bhullar

Paul Douglas Walling

Brian S Hill

William F Crismore

Daniel R McMinn

Jiaxiong Jason Ho

R Dale Delk

Christopher Douglas Wilsey

Brian A Heald

Robert Kitchel Earl

Michael Marquant

Terry Allen Beaty

Gerald F Sigler

Scott E Carpenter

Douglas Paul Walling

Randall K Riggles

Zheng Zheng Pan

Zhi David Deng

Tom Funke

Robert J McEnroe

Rebecca W Muddiman

Walter W Jernigan

Richard J Bodensteiner

Hans-Peter Haar

Frank A Chan

Stefan Weinert

Abner D Joseph

Vladimir Svetnik

Matthias Essenpreis

Martin Gerber

Karin Schwind

Remmert Laan

Melani G Sullivan

Richard J Kordal

Matt Sauers

Terry A Beaty

Daniel R Mcminn

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods further allow one to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature or both before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one AC block and at least one pulsed DC block, where pulsed DC block includes at least one recovery potential, and where a closed circuit condition of the electrode system is maintained during the DC block. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Methods of electrochemically measuring an analyte with a test sequence having a pulsed DC block as well as devices, apparatuses and systems incorporating the same

A method is disclosed for determining analyte concentration that includes applying a first electrical potential excitation pulse to a body fluid sample in an analyte sensor, and a first current response of the body fluid sample to the first pulse is measured. A second excitation pulse is applied to the body fluid sample in the analyte sensor, and a second current response of the body fluid sample to the second pulse is measured. An analyte level in the body fluid sample is determined by compensating for sources of error based on the first current response to the first pulse.

Systems and methods to compensate for sources of error during electrochemical testing

A collection device with a selective display of test results and method thereof are disclosed. A structured collection procedure defining data collection times and the associated context of the collection also defines what information regarding the results of the collection may be viewable by a user performing the structured collection procedure on the device. In this manner, the patient can be monitored according to the structured collection procedure while preventing the patient from modifying his or her behavior based on collection results.

Collection device with selective display of test results, method and computer program product thereof

Methods for decentralized monitoring of a progression of a diabetic state of a patient include contemporaneously obtaining an initial set of venous blood samples and an initial set of capillary blood samples after a standardized metabolic challenge from the patient in a centralized setting, wherein the diabetic state is diagnosed using the initial set of venous blood samples and a first test baseline is established by correlating the initial set of capillary blood samples with the initial set of venous blood samples, implementing a therapy, performing decentralized testing after reaching a target event, wherein a status test is obtained from a status set of capillary blood samples obtained from the patient after a subsequent standardized metabolic challenge, and comparing the status test with the first test baseline to determine an effectiveness of the therapy.

Methods and apparatus for decentralized diabetes monitoring

A method of measuring an analyte in a biological fluid comprises applying an excitation signal having a DC component and an AC component. The AC and DC responses are measured; a corrected DC response is determined using the AC response; and a concentration of the analyte is determined based upon the corrected DC response. Other methods and devices are disclosed.

System and method for analyte measurement using dose sufficiency electrodes

An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds&#x2014;without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Biosensor and method of making

A system for testing for analytes in a sample of biological fluid includes a test strip that defines a cavity for receiving the sample. At least two sets of electrodes are adjacent the sample cavity, including one for measuring one property of the sample, and another for measuring one or more other properties of the sample, such as temperature and/or the presence or magnitude of confounding variables. The measurements are combined to yield the desired result. At least one set of working and counter electrodes each have a plurality of elongated 'fingers' interdigitated with those of the other electrode in the set. The gaps between fingers can be quite small, so that the two electrode sets together can operate in a small measurement volume of sample. Additional electrodes can be included that measure the presence or sufficiency of the sample, and additional traces on the strip can act as configuration identifiers.

Devices and methods relating to electrochemical biosensors

A biosensor container comprising a housing defining an internal glucose test strip compartment. The housing has an engagement portion for retaining a detachable means for storing data, and the means for storing data has data stored thereon specific to a batch of glucose test strips. At least one of the housing and the means for storing data includes at least one data reading element that is externally accessible when the means for storing data is retained by the engagement portion of the housing. The container includes various fail safe features to prevent mishandling and insure the user obtains the correct results. The housing includes means for connecting to the bG meter only when the means for storing data is retained by the housing. The housing further includes means for dispensing glucose test strips only when the housing is in either of an attached-to meter mode or a stand-alone mode. In the attached-to-meter mode the means for storing data is retained by the housing and the housing is connected to a bG meter. In the stand-alone mode the means for storing data is detached from the housing and the housing is not connected to the bG meter.

Biosensor container

An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a 'fill to here' line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called 'dose hesitation'.

Electrochemical biosensor test strip

A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to 'target' with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.

Test strip with flared sample receiving chamber

Growing community of inventors

Indianapolis, IN, United States of America

Nigel A Surridge