Dual glucose-hydroxybutyrate analytical sensors
First Claim
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1. A dry reagent diagnostic device for the simultaneous enzymatic analysis of two different analytes in a single application of a single 1–
- 20 ul sample of whole blood, whereinthe fast analyte is determined by a fast reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines the second analyte;
a fluid bridge formed by the applied sample connects the two reaction zones;
said first reaction zone and second reaction zone having reaction materials and geometry;
selected to allow simultaneous rehydration and activation of both zones by a single unseparated whole blood drop;
said reaction zone materials and geometry being selected so as to return detectable analyte signals in the presence of whole blood;
said reaction zone materials and geometry being selected as to generate a detectable sample application signal upon initial contact with whole blood;
said detectable sample application signal being capable of triggering an automated reaction zone reader which is capable of performing subsequent test timing in an automated manner;
and at least one of the reaction zones produces a detectable change in an optical signal.
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Abstract
Diagnostic dry reagent tests capable of reacting with a single drop of whole blood and reporting both glucose and beta-hydroxybutyrate levels are taught. Such dry reagent tests may employ electrochemical detection methodologies, optical detection methodologies, or both methodologies. These tests help facilitate the early detection of the onset of ketoacidosis in diabetes.
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Citations
23 Claims
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1. A dry reagent diagnostic device for the simultaneous enzymatic analysis of two different analytes in a single application of a single 1–
- 20 ul sample of whole blood, wherein
the fast analyte is determined by a fast reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines the second analyte; a fluid bridge formed by the applied sample connects the two reaction zones; said first reaction zone and second reaction zone having reaction materials and geometry;
selected to allow simultaneous rehydration and activation of both zones by a single unseparated whole blood drop;said reaction zone materials and geometry being selected so as to return detectable analyte signals in the presence of whole blood; said reaction zone materials and geometry being selected as to generate a detectable sample application signal upon initial contact with whole blood; said detectable sample application signal being capable of triggering an automated reaction zone reader which is capable of performing subsequent test timing in an automated manner; and at least one of the reaction zones produces a detectable change in an optical signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- 20 ul sample of whole blood, wherein
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20. A method for determining the concentration of two or more analytes in a single sample of whole blood with a volume under 20 ul, comprising the steps of;
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applying said blood sample to a dry reagent diagnostic device in a single application, said dry reagent diagnostic device containing at least two reaction zones; wherein a first analyte in said sample is determined by a first reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines a second analyte in said sample; forming a fluid bridge with the applied blood sample to connect;
all reaction zones on said device;said first reaction zone and second reaction zone having reaction zone materials and geometry; and
selected to allow simultaneous rehydration and activation of all zones by a single unseparated whole blood drop;said reaction zone materials and geometry being selected as to return detectable analyte signals in the presence of whole blood; and determining the concentration of at least one of said analytes from at least one of said reaction zones by a detectable change in an optical signal. - View Dependent Claims (21, 22, 23)
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Specification