Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving glucose or galactose
Reexamination Certificate
2000-09-12
2002-07-16
Leary, Louise N. (Department: 1623)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving glucose or galactose
C435S025000, C435S004000, C435S283100, C435S975000, C435S026000
Reexamination Certificate
active
06420128
ABSTRACT:
FIELD OF THE INVENTION
The field of this invention is analyte measurement
BACKGROUND OF THE INVENTION
Analyte measurement 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 alcohol, formaldehyde, glucose, glutamic acid, glycerol, beta-hydroxybutyrate, L-lactate, leucine, malic acid, pyruvic acid, steroids, etc. In response to this growing importance of analyte measurement, a variety of analyte measurement protocols and devices for both clinical and home use have been developed. Many of the protocols and devices that have been developed to date employ a signal producing system to identify the presence of the analyte of interest in a physiological sample, such as blood.
While a variety of such signal producing systems have been developed to date for use in the measurement of a wide variety of different analytes, there continues to be a need for the further development of such systems.
Relevant Literature
Patent documents of interest include: EP 0 908 453 A1; WO 94/01578 and WO
SUMMARY OF THE INVENTION
Test strips and methods for their use in the detection of an analyte in a sample are provided. The subject test strips are characterized by at least including a water soluble tetrazolium salt on a surface of a positively charged substrate. In many embodiments, the water soluble tetrazolium salt is present as part of an analyte oxidizing signal producing system, which system includes one or more of the following additional components: an analyte oxidizing enzyme, e.g., an analyte dehydrogenase or an analyte oxidase; an electron transfer agent; and an enzyme cofactor. Also provided are systems and kits incorporating the subject test strips. The subject test strips, systems and kits find use in the measurement of a wide variety of analytes in a sample, such as a physiological sample, e.g., blood or a fraction thereof, or ISF (interstitial fluid).
REFERENCES:
patent: 3964974 (1976-06-01), Banauch et al.
patent: 0 908 453 (1997-04-01), None
patent: WO 94/01544 (1993-07-01), None
patent: WO 94/01578 (1993-07-01), None
Ouyang Tianmei
Yu Yeung Siu
Bozicevic, Field & Francis
Field Bret E.
Leary Louise N.
LifeScan, Inc.
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