Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
2000-02-02
2004-04-06
Forman, B. J. (Department: 1634)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S007100, C435S014000, C435S025000, C435S176000, C435S289100, C422S050000, C422S051000, C422S051000, C422S062000, C422S068100, C204S403060
Reexamination Certificate
active
06716577
ABSTRACT:
INTRODUCTION
1. Field of the Invention
The field of this invention is analyte determination, particularly electrochemical analyte determination and more particularly the electrochemical determination of blood analytes.
2. Background
Analyte detection in physiological fluids, e.g. blood or blood derived products, is of ever increasing importance to today's society. Analyte detection assays find use in a variety of applications, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in diagnosis and management in a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol, and the like. In response to this growing importance of analyte detection, a variety of analyte detection protocols and devices for both clinical and home use have been developed.
One type of method that is employed for analyte detection is an electrochemical method. In such methods, an aqueous liquid sample is placed into a reaction zone in an electrochemical cell comprising two electrodes, i.e. a reference and working electrode, where the electrodes have an impedance which renders them suitable for amperometric measurement. The component to be analyzed is allowed to react directly with an electrode, or directly or indirectly with a redox reagent to form an oxidizable (or reducible) substance in an amount corresponding to the concentration of the component to be analysed, i.e. analyte. The quantity of the oxidizable (or reducible) substance present is then estimated electrochemically and related to the amount of analyte present in the initial sample.
In electrochemical analyte detectors used to practice the above described methods, it is often desirable to modify the surface of the metal electrodes to be hydrophilic. A variety of different techniques have been developed to modify the surfaces of metal electrodes. However, such surface modified electrodes tend to have limited storage life, thus limiting their potential applications.
As such, there is continued interest in the identification of new methods for modifying metallic electrode surfaces for use in the electrochemical detection of analytes. Of particular interest would be the development of a method which resulted in a storage stable hydrophilic surface that provided rapid wicking time and did not interfere with the electrochemical measurements of the electrode.
Relevant Literature
U.S. Patent documents of interest include: U.S. Pat. Nos. 5,834,224; 5,942,102 and 5,972,199. Other patent documents of interest include WO 99/49307; WO 97/18465 and GB 2 304 628. Other references of interest include: Dalmia et al, J. Electroanalytical Chemistry (1997) 430: 205-214; Nakashima et al., J. Chem. Soc. (1990) 12: 845-847; and Palacin et al., Chem. Mater. (1996) 8:1316-1325.
SUMMARY OF THE INVENTION
Electrochemical test strips and methods for their use in the detection of an analyte, e.g. glucose, in a physiological sample, e.g. blood, are provided. The subject test strips have a reaction area 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.
REFERENCES:
patent: 5030310 (1991-07-01), Wogoman
patent: 5708247 (1998-01-01), McAleer et al.
patent: 5762770 (1998-06-01), Pritchard et al.
patent: 5834224 (1998-11-01), Ruger et al.
patent: 5869001 (1999-02-01), Backhaus et al.
patent: 5942102 (1999-08-01), Hodges et al.
patent: 5972199 (1999-10-01), Heller et al.
patent: 6306584 (2001-10-01), Bamdad
patent: 0 971 036 (2000-01-01), None
patent: 2 304 628 (1997-03-01), None
patent: 97/18465 (1997-05-01), None
patent: WO 99/19507 (1999-04-01), None
patent: 99/49307 (1999-09-01), None
Mizutani et al “Glucose oxidase/polyioin comlex-bilayer membrane for eleminaiton of electroactive interferents in amperometric glucose sensor” Analytica Chimica Acta, 1998, 364: 173-179.*
Nunes et al., “Evaluation of a highly sensitive amperometric biosensor with low cholinesterase charge immobilized on a chemically modified carbon past electrode for trace determination of carbamates in fruit, vegetable and water samples,”Analytica Chimica Acta399:37-49 (1999).
Shimojo et al., “Electrochemical Assay System with Single Use Electrode Strip for Measuring Lactate in Whole Blood”Clin Chem39(11):2312-2314 (1993).
Dalmia et al., “Electrochemical Behavior of Gold Electrodes Modified with Self-Assembled Monolayers with an Acidic End Group for Selective Detection of Dopamine,” J. Electroanalytical Chem. (1997) 430: 205-214.
Nakashima et al., “Assembled Supported Monolayers of Synthetic Lipids on Gold Electrodes via ‘Ion-Exchange Methods’,” J. Chem. Soc. (1990) 12: 845-847.
Palacin et al., “Patterning with Magnetic Materials at the Micron Scale,” Chem. Mater. (1996) 8:1316-1325.
Shah Mahesh
Yu Yeung Siu
Bozicevic Field & Francis LLP
Field Bret E.
Forman B. J.
LaSalle Carol M.
LifeScan, Inc.
LandOfFree
Electrochemical test strip for use in analyte determination does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Electrochemical test strip for use in analyte determination, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Electrochemical test strip for use in analyte determination will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3230921