Dual glucose-hydroxybutyrate analytical sensors
First Claim
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1. :
- A diagnostic dry reagent for the simultaneous enzymatic analysis of two different analytes in a single sample of whole blood, wherein the first analyte is determined by a first 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;
application of a single drop of whole blood hydrates the reaction zones, and initiates the beginning of the test;
excess blood does not have to be manually removed by the user;
and the user does not have to perform a manual timing step.
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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
32 Claims
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1. :
- A diagnostic dry reagent for the simultaneous enzymatic analysis of two different analytes in a single sample of whole blood, wherein
the first analyte is determined by a first 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;
application of a single drop of whole blood hydrates the reaction zones, and initiates the beginning of the test;
excess blood does not have to be manually removed by the user;
and the user does not have to perform a manual timing step. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- A diagnostic dry reagent for the simultaneous enzymatic analysis of two different analytes in a single sample of whole blood, wherein
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22. :
- A meter for use with a diagnostic dry reagent for the simultaneous enzymatic analysis of two different analytes in a single 1-20 ul sample of whole blood, wherein the first analyte is determined by a first reaction zone, the second analyte is determined by a second reaction zone physically separated from the first reaction zone, and wherein the two reaction zones are connected by a fluid bridge formed by the applied sample, and
wherein application of the sample of whole blood both hydrates the reaction zones, and initiates the beginning of the test, wherein the meter initiates data collection upon application of sample to the reagent, and wherein the meter collects a plurality of data points from both reaction zones, processes the data, and returns the value of both analytes to the user. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30)
- A meter for use with a diagnostic dry reagent for the simultaneous enzymatic analysis of two different analytes in a single 1-20 ul sample of whole blood, wherein the first analyte is determined by a first reaction zone, the second analyte is determined by a second reaction zone physically separated from the first reaction zone, and wherein the two reaction zones are connected by a fluid bridge formed by the applied sample, and
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31. :
- A triggering method to initiate the start of an optical dry reagent test device, said triggering method comprising;
a tracking dye composition on the dry reagent test device that increases reflectance on at least one wavelength upon contact with an applied sample;
an automated photometric system that performs a series of readings upon the tracking dye;
wherein upon contact with a fluid sample, the dye composition increases reflectance on at least one wavelength, which is detected by an automated photometric system and used to initiate the start of data acquisition for the test.
- A triggering method to initiate the start of an optical dry reagent test device, said triggering method comprising;
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32. :
- An electrical triggering method to initiate the start of an optical dry reagent test device, wherein upon contact with a fluid sample, an amperometric, potentiometric, conductometric, or impedence change in the electrical characteristics of the reagent is detected by an automated system, and used to initiate the start of optical data acquisition for the test.
Specification