Test device, method of manufacturing same and method of determining a component in a sample
First Claim
1. A test article for detecting the relative concentration of glucose in a test fluid comprising a matrix layer polymerized from a polymerizable compound dispersed in a carrier liquid and having homogeneously incorporated therein a reagent system capable of reaction with glucose in said test fluid to produce a detectable change in said matrix layer, and wherein said polymerizable compound is a glucose permeable, silicone water-based elastomer compound.
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Accused Products
Abstract
A method of manufacturing the test device and method of determining the presence and relative concentration of a component in a test sample. The device includes a carrier matrix incorporated with a reactant system capable of interacting with a sample component to produce a detectable response. For home use, the reactant system produces a visibly detectable response. The carrier matrix of the device comprises a new and improved whole blood compatible, glucose-permeable strip or layer of a polymerizable silicone material. A reactant system is homogeneously mixed into the polymerizable carrier matrix prior to complete curing of the matrix, and the matrix then is cured to hold the reactant system homogeneously throughout the carrier matrix in a known concentration while maintaining matrix penetrability of the predetermined component after complete curing of the carrier matrix. The carrier matrix is formed from a dispersion of a polymerizable silicon-containing compound applied in an incompletely cured from in a liquid carrier containing a homogeneously mixed reactant system.
193 Citations
38 Claims
- 1. A test article for detecting the relative concentration of glucose in a test fluid comprising a matrix layer polymerized from a polymerizable compound dispersed in a carrier liquid and having homogeneously incorporated therein a reagent system capable of reaction with glucose in said test fluid to produce a detectable change in said matrix layer, and wherein said polymerizable compound is a glucose permeable, silicone water-based elastomer compound.
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10. A reagent strip for sensing the presence of a chemical compound in a liquid, comprising:
a silicone water-based polymerizable material permeable to a liquid chemical compound and including a reagent system incorporated homogeneously into the silicone water-based material, said reagent system including a catalyst capable of causing reaction of the chemical compound to produce H2 O2, and a material capable of reaction with the H2 O2 to produce a detectable color change in said silicone water-based material. - View Dependent Claims (11, 12)
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13. An article for determining the relative concentration of glucose in a biological fluid comprising:
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a glucose-permeable polymerized layer formed from a layer of a dispersed, polymerizable silicone water-based elastomer in a removable carrier liquid, said silicone elastomer being substantially immiscible in said carrier liquid, and a portion of said carrier liquid being removed during polymerization of said silicone elastomer in dispersed, layered form; and a glucose reagent system incorporated into said layer of disperesed, polymerizable silicone water-based elastomer by mixing said reagent system into said carrier liquid.
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14. A method of manufacturing a test article for determining the presence of a predetermined chemical compound in a test fluid comprising:
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mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent containing matrix material; forming said reagent-containing matrix material into a layer on a support surface; and drying said layer and polymerizing said silicone polymerizable material on said support surface while removing said carrier liquid to form a dried matrix material layer permeable to a predetermined chemical compound and containing reagent composition capable of reaction with the predetermined chemical compound in a test fluid when the predetermined chemical compound penetrates into said dried matrix material layer; wherein a catalyst is added to the reagent containing matrix material, said catalyst capable of causing a reaction with the predetermined chemical compound in the test fluid to produce hydrogen peroxide;
a substance having peroxidative activity is added to the reagent containing matrix material; and
a compound capable of reaction to a colored form or reaction to change color in the presence of hydrogen peroxide is added to the regaent containing matrix material. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method of measuring the concentration of a predetermined chemical compound in a test fluid comprising:
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mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent-containing matrix material permeable to a predetermined chemical compound in a test fluid; forming said reagent-containing matrix material into a layer; and drying said layer and polymerizing said polymerizable material while removing said carrier liquid to form a dried matrix material layer permeable to said predetermined chemical compound and containing a reagent composition capable of reaction with said predetermined chemical compound when said predetermined chemical compound penetrates into said dried matrix material layer; contacting a surface of said dried matrix material layer with said test fluid to cause a visibly detectable color change in said matrix material layer; and determining the concentration of said predetermined chemical compound based upon the degree of said color change. - View Dependent Claims (26, 27)
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28. A method of manufacturing a test device including a continuous layer of a silicone containing polymer permeable to a predetermined chemical compound while screening out hemoglobin and other coloring bodies found in whole blood comprising:
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dispersing a polymerizable silicone containing compound in removable carrier liquid to form an incompletely cured polymerizable layer forming composition, said silicone containing compound being substantially immiscible in said carrier liquid; adding a reagent composition to said polymerizable layer forming a composition capable of interaction with a predetermined chemical compound to produce a detectable color change in said polymerizable layer; applying said incompletely cured polymerizable layer forming composition containing said reagent composition onto a support surface; and polymerizing said silicone containing compound while in layer form and removing at least a portion of the carrier liquid during polymerization of the silicone containing compound in dispersed, layered form, to form a cured, continuous polymerized silicone containing compound layer permeable to said predetermined chemical compound. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification