Compositions containing a urea derivative dye for detecting an analyte and methods for using the same
First Claim
Patent Images
1. A storage stable composition of matter comprising:
- a positively charged porous matrix comprising nylon; and
a urea derivative dye on at least one surface of said matrix, wherein said urea derivative dye is 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine or a salt thereof;
wherein said composition is stable for at least about six months at temperatures ranging from at least about −
80°
C. to 60°
C. under humidity ranging from at least about 0% to 20%.
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Abstract
Compositions, reagent test strips, analyte detection systems and kits of the same, as well as methods for their use in the detection of an analyte in a sample, are provided. The subject compositions are characterized by having a positively charged porous matrix and a urea derivative dye on at least one surface of the matrix, where in many preferred embodiments the urea derivative dye is a negatively charged urea derivative dye. In many preferred embodiments, the subject compositions further include at least one additional reagent member of a peroxide producing signal producing system, e.g., an analyte oxidase and/or a peroxidase. The subject compositions, test strips, analyte detection systems and kits find use in the detection of a wide variety of analytes in a sample, such as a physiological sample, e.g., blood or a fraction thereof.
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Citations
19 Claims
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1. A storage stable composition of matter comprising:
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a positively charged porous matrix comprising nylon; and
a urea derivative dye on at least one surface of said matrix, wherein said urea derivative dye is 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine or a salt thereof;
wherein said composition is stable for at least about six months at temperatures ranging from at least about −
80°
C. to 60°
C. under humidity ranging from at least about 0% to 20%.- View Dependent Claims (2, 3, 4, 5, 6)
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7. A storage stable reagent test strip for use in detecting the presence or determining the concentration of an analyte in a physiological sample, said strip comprising:
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a positively charged porous matrix comprising nylon; and
a peroxide producing signal producing system present on said matrix, wherein said peroxide producing signal producing system includes 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine or a salt thereof, wherein said test strip is stable for at least about six months at temperatures ranging from at least about −
80°
C. to 60°
C. under humidity ranging from at least about 0% to 20%.- View Dependent Claims (8, 9, 10)
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11. An analyte detection or measurement system comprising:
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(a) a storage stable reagent test strip comprising;
(i) a positively charged porous matrix comprising nylon; and
(ii) a peroxide producing signal producing system present on said matrix, wherein said peroxide producing signal producing system includes 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine or a salt thereof; and
(b) an automated instrument, wherein said test strip is stable for at least about six months at temperatures ranging from at least about −
80°
C. to 60°
C. under humidity ranging from at least about 0% to 20%.
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12. A method for detecting the presence or determining the concentration of an analyte in a sample, said method comprising:
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(a) applying said physiological sample to a storage stable reagent test strip comprising;
(i) a positively charged porous matrix comprising nylon; and
(ii) a peroxide producing signal producing system present on said matrix, wherein said peroxide producing signal producing system includes 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine or a salt thereof, wherein said test strip is stable for at least about six months at temperatures ranging from at least about −
80°
C. to 60°
C. under humidity ranging from at least about 0% to 20%;
(b) detecting a signal produced by said signal producing system; and
(c) relating said detected signal to the presence or concentration of said analyte in said physiological sample. - View Dependent Claims (13, 14, 15)
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16. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:
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(a) a storage stable reagent test strip comprising;
(i) a positively charged porous matrix comprising nylon; and
(ii) a peroxide producing signal producing system present on said matrix, wherein said peroxide producing signal producing system includes 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino)phenothiazine or a salt thereof, wherein said test strip is stable for at least about six months at temperatures ranging from at least about −
80°
C. to 60°
C. under humidity ranging from at least about 0% to 20%; and
(b) at least one of;
(i) a means for obtaining said physiological sample and (ii) an analyte standard. - View Dependent Claims (17, 18, 19)
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Specification
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Current AssigneeCilag Gmbh International (Johnson & Johnson)
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Original AssigneeLifescan Incorporated (Duv Holding Corporation)
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InventorsGuo, Sherry X., Leong, Koon-wah
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Primary Examiner(s)GITOMER, RALPH J
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Application NumberUS09/593,827Time in Patent Office1,449 DaysField of Search435/4, 435/12, 435/14, 435/25, 435/28, 435/287.1, 435/287, 435/287.7US Class Current435/14CPC Class CodesC12Q 1/28 involving peroxidaseG01N 33/521 Single-layer analytical ele...
