Electrolysis: processes – compositions used therein – and methods – Electrolytic analysis or testing – Involving enzyme or micro-organism
Reexamination Certificate
2000-12-20
2003-05-06
Tung, T. (Department: 1743)
Electrolysis: processes, compositions used therein, and methods
Electrolytic analysis or testing
Involving enzyme or micro-organism
C204S403140, C205S792000
Reexamination Certificate
active
06558528
ABSTRACT:
INTRODUCTION
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.
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 analyzed, 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.
A problem faced by manufacturers and users of these types of electrochemical test strips is reagent degradation due to water exposure. For example, when the reagent composition of such strips is exposed to normal environmental humidity, the response of the test strip can change dramatically and therefore confound the results obtained with the strip.
As such, there is continued interest in the identification of new electrochemical strip configurations in which the reagent composition of the strip is protected from contact with environmental humidity. Of particular interest would be the development of a card from which a plurality of test strips could be singulated, where the reagent composition in each card is protected from water mediated degradation.
Relevant Literature
Patent documents of interest include: U.S. Pat. Nos. 5,708,247; 5,942,102; 5,951,836; 5,972,199; 5,989,917; 5,997,817; 6,151,110; 6,125,292; WO 97/18465; WO 97/27483 and EP 871 033.
SUMMARY OF THE INVENTION
Electrochemical test strip cards that can be singulated to produce electrochemical test strips are provided. The electrochemical test cards are made up of two or more electrochemical test strip precursors, where each precursor is characterized by the presence of a dry reagent housing reaction chamber bounded by opposing electrodes. In gaseous communication with each reaction chamber of the card is an integrated desiccant. Also provided are methods of using the subject electrochemical test strips cards, as well as kits that include the same. The subject test strips and cards find use in the detection/concentration determination of a number of different analytes, including glucose.
REFERENCES:
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patent: 6125292 (2000-09-01), Uenoyama et al.
patent: 6151110 (2000-11-01), Markart
patent: 0 871 033 (1998-10-01), None
patent: WO 97/18465 (1997-05-01), None
patent: WO 97/27483 (1997-07-01), None
Bozicevic Field & Francis LLP
LaSalle Carol M.
Lifescan Inc.
Noguerola Alex
Tung T.
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