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;
(b) water-insoluble particles having a nominal size of about 0.05 to 20 μ
m;
(c) an enzyme system for reacting with said analyte; and
wherein the weight ratio of said water-insoluble particles to said water-soluble swellable polymer matrix is about 1/2 to 2/1.
2 Assignments
0 Petitions
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.
14 Citations
58 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; (b) water-insoluble particles having a nominal size of about 0.05 to 20 μ
m;(c) an enzyme system for reacting with said analyte; and wherein the weight ratio of said water-insoluble particles to said water-soluble swellable polymer matrix is about 1/2 to 2/1. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 53, 54, 55, 56)
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11-31. -31. (canceled)
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32. 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; (2) water-insoluble particles having a nominal size of about 0.05 to 20 μ
m;(3) an enzyme system for oxidizing said glucose, and; (4) 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. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 57, 58)
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44-52. -52. (canceled)
Specification