Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving oxidoreductase
Reexamination Certificate
2001-11-20
2003-07-01
Leary, Louise N. (Department: 1654)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving oxidoreductase
C435S025000, C435S014000, C435S004000, C435S975000
Reexamination Certificate
active
06586199
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: U.S. Pat. No. 6,200,773; U.S. Pat. No. 5,902,731; EP 0 908 453 A1; WO 94/01578 and WO 94/01544.
SUMMARY OF THE INVENTION
Stabilized tetrazolium dye reagent compositions that include a tetrazolium dye reagent, e.g., a water soluble tetrazolium salt, and a nitrite tetrazolium dye stabilizing reagent, e.g., a nitrite salt, are provided. In many embodiments, the reagent compositions include members of analyte oxidizing signal producing system of which the tetrazolium dye is a member, 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 test strips that include the subject reagent compositions, as well as systems and kits incorporating the subject test strips. The subject reagent compositions, 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: 5902731 (1999-05-01), Ouyang et al.
patent: 6200773 (2001-03-01), Ouyang et al.
patent: 0908453 (1999-04-01), None
patent: WO 94/01544 (1994-01-01), None
patent: WO 94/01578 (1994-01-01), None
Huang Paing
Ouyang Tianmei
Bozicevic Field & Francis LLP
Field Brett E.
LaSalle Carol M.
Leary Louise N.
LifeScan, Inc.
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