Size self-limiting compositions and test devices for measuring analytes in biological fluids
First Claim
1. A reactive formulation for measuring the amount of an analyte in a biological fluid comprising:
- (a) a water-soluble swellable polymer matrix including water-insoluble particles having a nominal size of about 0.05 to 20 μ
m; and
(b) an enzyme system for reacting with said analyte,wherein the weight ratio of said water-insoluble particles to said water-soluble swellable polymer matrix is about 1/2 to 2.1/1, wherein the reactive formulation has a thickness of about 6 to 16 μ
m.
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Accused Products
Abstract
A test strip or electrochemical sensor for measuring the amount of an analyte in a biological fluid, e.g. the glucose content of whole blood, includes a size self-limiting reagent formulation employing an enzyme system for reaction with the analyte, the reactive system mixed into a water-soluble swellable polymer matrix containing small water-insoluble particles having a nominal size of about 0.05 to 20 μm, preferably about 1 to 10 μm. The weight ratio of the water-insoluble particles to the water-soluble swellable polymer matrix is about 1/2 to 2/1. The reagent formulation is deposited onto a non-porous substrate to form a thin layer about 6-16 μm thick, providing a rapid and stable response to application of a sample, while being insensitive to the amount of the sample.
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Citations
25 Claims
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1. A reactive formulation for measuring the amount of an analyte in a biological fluid comprising:
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(a) a water-soluble swellable polymer matrix including water-insoluble particles having a nominal size of about 0.05 to 20 μ
m; and(b) an enzyme system for reacting with said analyte, wherein the weight ratio of said water-insoluble particles to said water-soluble swellable polymer matrix is about 1/2 to 2.1/1, wherein the reactive formulation has a thickness of about 6 to 16 μ
m. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 21, 22, 23, 24)
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10. A test strip for measuring the glucose content of whole blood samples comprising:
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(a) a substantially non-porous substrate; (b) a reagent layer disposed on said substrate, said reagent layer comprising; (1) a water-soluble swellable polymer matrix including water-insoluble particles having a nominal size of about 0.05 to 20 μ
m;(2) an enzyme system for oxidizing said glucose, and; (3) an indicator; (c) a protective covering for said reagent layer of (b). (d) an adhesive layer between said reagent layer and said protective covering, said adhesive layer having a capillary channel for receiving said blood sample, wherein the weight ratio of said water-insoluble particles to said water-soluble swellable polymer matrix is about 1/2 to 2.1/1, wherein the reagent layer has a thickness of about 6 to 16 μ
m. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25)
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Specification