Boehringer Mannheim Gmbh

Roche Diabetes Care, Inc.

Roche Diagnostics Operations, Inc.

Boehringer Mannheim Corporaton

F. Hoffmann-la Roche Ag

Harvey Buck

Fern DeLaCroix

Rupert Herrmann

Michael Marquant

Terry Allen Beaty

Paul J Galley

Stefan Weinert

Scott E Carpenter

Steven Bousamra

Johann Berger

Hans-Joachim Guder

Werner Guthlein

Karl-Heinz Koelker

Ewald Rieger

Walter Jernigan

Arnulf Staib

Manfred Kuhr

Reinhold Mischler

Martin Gerber

James R Long

Siva Chittajallu

Nicole Bernini

Otto Gaa

Robin S Wagner

Zheng Zheng Pan

Jürgen Rasch-Menges

Georgeta C Lica

Stacy Hunt DuVall

Martin Hajnsek

Erica Diebold

Juergen Schrenk

Hans Berger

Ajay Thukral

Wolfgang Weckerle

Rene Valverde-Ventura

Sybille Froech

Bernd Rösicke

David D Webster

Kym Marco

Stefhan Weinert

James C Hengst

Bernd Hilger

Marius Brizgys

Erica R Diebold

Erica Rose Diebold

Detection reagents, multi-analyte test elements, test systems, and multi-analyte measuring methods are provided. In particular, multi-analyte test elements have (1) a first working electrode and first counter electrode pair covered with a first analyte-specific reagent that includes an enzyme, a coenzyme and a first mediator and have (2) a second working electrode covered with a second analyte-specific reagent that includes an enzyme, a coenzyme and a second mediator, where the second mediator is different than the first mediator. The single counter electrode can be used as the counter electrode for both the first and second analyte measurements at their respective working electrodes. Moreover, the mediator concentrations, measurement ranges, and applied potential differences are not the same for each analyte-specific measurement.

Detection reagents and electrode arrangements for multi-analyte diagnostic test elements, as well as methods of using the same

A method is provided for verifying test element integrity includes providing a biosensor having an electrode-support substrate. A first electrode is provided on the substrate that includes a first body and a neck extending from the first body. A second electrode is provided on the substrate that includes a second body and an opposite pair of necks. Each of the necks extends from a respective end of the second body. A spacer is positioned on the substrate and has an edge defining a boundary of a capillary channel formed between a cover and the substrate. The method also includes applying a signal across the necks of the second electrode to verify continuity along the second electrode. The second body of the second electrode and the pair of connective necks surround the first electrode in the capillary channel forming a loop circuit around the first electrode.

Electrode arrangements for test element integrity

Electrode arrangements for test elements, test elements and methods of determining sample sufficiency, monitoring fill time, establishing fill directions and/or confirming electrode coverage by a sample for test elements are disclosed. The test elements have an electrode-support substrate including a spacer having an edge defining a boundary of a capillary channel. The electrode-support substrate also includes a first electrode pair and a second electrode pair, wherein the first electrode pair is positioned between the second electrode pair. The method includes dosing the test sensor with the fluid sample; applying a signal to the first electrode pair and the second electrode pair, detecting a first response to the signal from the first electrode pair, and detecting a second response to the signal from the second electrode pair; determining a time period between the first response and the second response and then applying a measurement test sequence for an analyte of interest on the fluid sample if the time period is less than a first predetermined threshold.

Electrode arrangements for electrochemical test elements and methods for use thereof

Electrode arrangements for electrochemical test elements

The present invention provides an electrochemical sensor that employs multiple electrode areas that are exposed for contact with a body fluid, e.g., when the sensor is inserted subcutaneously into a patient's skin. The exposed electrode areas are arranged symmetrically, such that a symmetrical potential distribution is produced when an AC signal is applied to the sensor. The sensors in accordance with these teachings can advantageously be used with AC signals to determine characteristics of the sensor and thus improve sensor performance. These teachings also provide a biocompatible sensor with multiple reference electrode areas that are exposed for contact with body fluid.

Electrochemical sensor having symmetrically distributed analyte sensitive areas

An in vivo amperometric sensor is provided for measuring the concentration of an analyte in a body fluid. The sensor comprises a counter electrode and a working electrode, and the working electrode comprises a sensing layer which is generally water permeable and arranged on a support member adjacent to a contact pad. The sensing layer comprises an immobilized enzyme capable of acting catalytically in the presence of the analyte to cause an electrical signal. The sensing layer has an upper surface facing the body fluid and a lower surface facing away from the body fluid, and the immobilized enzyme is distributed within the sensing layer in such a way that the enzyme concentration in the middle between the upper and lower surfaces is at least as high as on the upper surface of the sensing layer.

Amperometric sensor and method for its manufacturing

A system for determining drug administration information may comprise an input device providing for user input of feed forward information having a first parameter component and a second parameter component, a data storage device and a processor. The data storage device may have stored therein a map correlating values of the first and second parameters to drug administration information. The processor may be responsive to user input of the feed forward information to determine corresponding drug administration information according to the map.

System and method for determining drug administration information

The invention relates to a test system useful in carrying out diagnostic assays. One component of the test system is an unblocked solid phase test carrier with a three dimensional configuration, impregnated with a first binding partner for analyte of interest. The second component of a binding agent containing a second binding partner coupled to an immediately visually determinable label, and a blocking agent. Rapid and accurate assays may be carried out by using the described system.

Assay using an unblocked solid phase with immobilized analyte binding

A method of detecting hydrolase activity using as substrates the compounds of the formula ##STR1## wherein each of R.sup.1, R.sup.2 and R.sup.3 is C.sub.1 -C.sub.4 alkyl, or phenyl optionally substituted in the meta- or para- position by C.sub.1 -C.sub.6 alkyl, C.sub.1 -C.sub.6 alkoxy or mono- or di-(C.sub.1 -C.sub.6)-alkylamino, or optionally substituted by an O-X group in which X is a glycosyl, phosphate or acyl moiety of a natural substrate of the corresponding glycosidase, phosphatase or esterase.

Agents for the detection of substrates with hydrolase activity

A process for the detection of substances with hydrolase activity in a sample by mixing the sample with a hydrolase substrate and an oxidising agent, and the evaluating the resultant colour intensity, wherein, as hydrolase substrate, there is used at least one compound of the formula ##STR1## in which R.sup.1 is hydrogen or an alkoxy radical,

Agent for the detection of substances with hydrolase activity

The invention relates to an assay for determining an analyte in a fluid sample. Three receptors are used, with formation of a quaternary or four member complex. One of the receptors is bound to a solid phase, and binds to complexes of another receptor and the analyte. A third receptor is labelled, and it, too, binds analyte. The invention also involves the use of a displacement solution to wash fluid sample from solid phase after the first portion of the quaternary complex forms, i.e., prior to binding with the labelled receptor.

Method for sequential determination of an analyte in a fluid sample

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Indianapolis, IN, United States of America

Harvey Buck