Lifescan Corporation

Cilag International Gmbh

Maria Teodorczyk

Mahyar Zardoshti Kermani

Remedios Dato

Ronald Christopher Chatelier

Timothy J Ohara

Koon-Wah Leong

Alastair McIndoc Hodges

Lorin Philip Olson

Alastair McIndoe Hodges

David P Matzinger

Ernest J Kiser

Sherry Guo

Devin McAllister

Vadim V Yuzhakov

Michael F Tomasco

Robert Justice Shartle

Edward G Rice

Alastair Mcindoe Hodges

Darwin R Poulos

Remy Dato

Sherry X Guo

Methods and systems to apply a plurality of test voltages to the test strip and measure a current transient output resulting from an electrochemical reaction in a test chamber of the test strip so that a glucose concentration can be determined that account for interferent substances in the body fluid sample. A method of determining blood glucose concentration with a glucose measurement system that includes a test strip and test meter. The test meter has a microcontroller configured to apply a plurality of test voltages to the test strip and measure a current transient output resulting from an electrochemical reaction in a test chamber of the test strip.

System and method for measuring an analyte in a sample and correcting for interferents

Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

Systems and methods of discriminating control solution from a physiological sample

Described are methods and systems to calculate an analyte concentration of a sample are provided without temperature compensation to a glucose concentration calculation when a measured or sampled current is taken at or before a change in a first voltage to a second voltage that are applied to a test trip with electrodes in a test cell.

System and method for measuring an analyte in a sample

Systems and methods for discriminating control solution from a physiological sample

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

Mediator stabilized reagent compositions and methods for their use in electrochemical analyte determination assays are provided. The subject reagent compositions include an enzyme, a redox mediator and a mediator-stabilizing buffer. Optionally, the reagent compositions may further include one or more of a wetting agent, detergent, enzyme cofactor and combinations thereof. Also provided are electrochemical test strips that include the subject reagent compositions, systems and kits that include the same as well as methods for using the same in analyte detection assays. The subject invention finds use in a variety of different applications, including glucose concentration determination applications.

Mediator stabilized reagent compositions and methods for their use in electrochemical analyte detection assays

Methods and systems are provided for determining whether a volume of biological sample is adequate to produce an accurate electrochemical analyte concentration measurement. Certain such methods and systems provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.

Determination of sample volume adequacy in biosensor 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

The present invention provides methods and systems for passively and automatically detecting the presence of a sample (the 'sample detection phase') upon application of the sample to a biosensor, identifying the sample detection time and then initiating the measurement of a targeted characteristic, e.g., the concentration of one or more analytes, of the sample (the 'measurement phase'), immediately upon sample detection. The subject methods and systems do not employ or involve the application of an electrical signal from an external source to the electrochemical cell for purposes of performing the sample detection phase and are, thus, less complicated and involve fewer steps and components.

Passive sample detection to initiate timing of an assay

Methods and devices for electrochemically detecting a change in the viscosity of a fluid are provided. In the subject methods, a fluid sample is introduced into an electrochemical cell having oppositely spaced apart working and reference electrodes. An electric potential is applied to the 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. Also provided are test strips, kits thereof and meters for use in practicing the subject methods.

Electrochemical coagulation assay and device

An electrochemical assay includes a method for determining with great accuracy the time at which an applied sample bridges a gap between the electrodes of an electrochemical cell. The method involves applying a constant small current across the gap, while monitoring the potential difference between the electrodes. The time at which the sample bridges the gap is marked by a sharp drop in the potential. A constant voltage is applied after the sample is detected, and the current and/or charge through the sample is monitored over a period of time. From the measured current or charge, the analyte concentration of interest can be calculated.

Sample detection to initiate timing of an electrochemical assay

A reagent strip for measuring glucose concentration in a biological fluid containing red blood cells has reduced interference of hematocrit with the glucose measurement. When a biological fluid contacts the strip, it causes, in a reagent impregnated in the strip, a color change which is a measure of the glucose concentration in the fluid. However, the color change is also affected by the red blood cell concentration (hematocrit), thereby reducing the accuracy of the glucose measurement. The hematocrit effect is reduced by adding to the reagent a component, such as imidazole or imidazole and N-acetylglucosamine, for minimizing side reactions of the glucose, or its reaction products, with the fluid.

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San Jose, CA, United States of America

Maria Teodorczyk