Test device and method of assaying for fructosamines
First Claim
1. A composition capable of exhibiting a sufficient color transition upon contacting a fructosamine-containing liquid test sample to indicate the presence or concentration of fructosamine in the test sample comprising:
- (a) a chromogenic indicator dye capable of being reduced by a fructosamine;
(b) a buffer to maintain the pH of the composition at a value of at least about 11; and
(c) a reaction accelerator compound to enable the reaction between the fructosamine and the chromogenic indicator dye to proceed at ambient temperature.
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Accused Products
Abstract
A new and improved test device and method of determining the presence and concentration of fructosamines in a test sample. The test device includes a test pad comprising a carrier matrix incorporating an indicator reagent composition capable of interacting with fructosamines to produce a detectable or measurable response. The carrier matrix of the device includes a bibulous matrix, such as filter paper, or a nonbibulous matrix, such as a polymeric film. In addition, a new and improved indicator reagent composition comprising a dye, such as tetrazolium violet; a suitable buffer; and an accelerator compound is incorporated into the carrier matrix to provide a test pad demonstrating sufficient color resolution and having sufficient sensitivity to fructosamines in a test sample. Therefore, a fast, more accurate and trustworthy fructosamine assay of a liquid test sample, such as whole blood or serum, is achieved. The improved method of determining the presence or concentration of fructosamines in a liquid test sample is especially useful in the diagnosis and treatment of diabetes mellitus.
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Citations
39 Claims
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1. A composition capable of exhibiting a sufficient color transition upon contacting a fructosamine-containing liquid test sample to indicate the presence or concentration of fructosamine in the test sample comprising:
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(a) a chromogenic indicator dye capable of being reduced by a fructosamine; (b) a buffer to maintain the pH of the composition at a value of at least about 11; and (c) a reaction accelerator compound to enable the reaction between the fructosamine and the chromogenic indicator dye to proceed at ambient temperature. - View Dependent Claims (2, 3)
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4. A composition capable of exhibiting a sufficient color transition upon contacting a fructosamine-containing liquid test sample to indicate the presence or concentration of fructosamine in the test sample comprising:
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(a) a chromogenic indicator dye capable of being reduced by a fructosamine; (b) a buffer to maintain the pH of the composition at a value of at least about 11; and (c) a reaction accelerator compound capable of accelerating the reaction between the fructosamine and the chromogenic indicator dye selected from the group consisting of a nonionic surfactant, an organic solvent and combinations thereof. - View Dependent Claims (5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of determining the presence or concentration of fructosamines in a liquid test sample comprising:
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(a) contacting the liquid test sample with a composition comprising a chromogenic indicator dye capable of being reduced by a fructosamine, a buffer to maintain the pH of the composition at a value of at least about 11, and a reaction accelerator compound capable of accelerating the reaction between the fructosamine and the chromogenic indicator dye selected from the group consisting of a nonionic surfactant, an organic solvent and combinations thereof; and (b) determining the presence or concentration of fructosamines in the liquid test sample from the intensity or degree of color change of the composition. - View Dependent Claims (24, 25, 26, 27, 28, 29)
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30. A method of determining the presence or concentration of fructosamines in a liquid sample comprising:
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(a) contacting the liquid sample with an analyte detection device comprising a reagent test pad including a composition comprising a chromogenic indicator dye capable of being reduced by a fructosamine, a buffer to maintain the pH of the composition at a value of at least about 11, and a reaction accelerator compound capable of accelerating the reaction between the fructosamine and the chromogenic indicator dye selected from the group consisting of a nonionic surfactant, an organic solvent and combinations thereof; and (b) examining the analyte detection device for a color transition in response to the fructosamine content of the liquid sample.
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31. A method of detecting and measuring glucose in a test sample comprising:
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(a) contacting the test sample with a reagent composition comprising a chromogenic indicator dye capable of being reduced by a fructosamine, a buffer to maintain the pH of the composition at a value of at least about 11, and a reaction accelerator compound capable of accelerating the reaction between the fructosamine and the chromogenic indicator dye selected from the group consisting of a nonionic surfactant, an organic solvent and combinations thereof; (b) detecting and measuring the amount of fructosamines in the test sample from the intensity or degree of color change of the reagent composition; and (c) correlating the amount of fructosamines in the test sample to the amount of glucose in the test sample. - View Dependent Claims (32, 33, 34, 35)
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36. A method of detecting diabetes mellitus by determining the concentration of glucose in a blood sample comprising:
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(a) contacting the blood sample with an analyte detection device comprising a reagent test pad including a reagent composition comprising a chromogenic indicator dye capable of being reduced by a fructosamine, a buffer to maintain the pH of the composition at a value of at least about 11, and a reaction accelerator compound capable of accelerating the reaction between the fructosamine and the chromogenic indicator dye selected from the group consisting of a nonionic surfactant, an organic solvent and combinations thereof; (b) examining the analyte detection device for a color transition in response to a fructosamine concentration of the blood sample; (c) determining the fructosamine concentration of the blood sample from the intensity or degree of the color transition; and (d) correlating the fructosamine concentration of the blood sample to the glucose concentration of the blood sample.
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37. An analyte detection device to determine the presence or concentration of fructosamine in a liquid test sample comprising:
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a support strip; a reagent test pad; and a reagent composition incorporated into the reagent test pad, said reagent composition comprising (a) a chromogenic indicator dye capable of being reduced by a fructosamine to undergo a color transition; (b) a buffer to maintain the pH of the composition at a value of at least about 11; and (c) a reaction accelerator compound to enable the reaction between the fructosamine and the chromogenic indicator dye to proceed at ambient temperature. - View Dependent Claims (38)
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39. An analyte detection device to determine the presence or concentration of glucose in a liquid test sample comprising:
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a support strip; a reagent test pad; and a reagent composition incorporated into the reagent test pad, said reagent composition comprising (a) a chromogenic indicator dye capable of being reduced by a fructosamine to undergo a color transition; (b) a buffer to maintain the pH of the composition at a value of at least about 11; and (c) a reaction accelerator compound capable of accelerating the reaction between the fructosamine and the chromogenic indicator dye selected from the group consisting of a nonionic surfactant, an organic solvent and combinations thereof.
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Specification