Reagent stripe for test strip
First Claim
1. A method of manufacturing a test strip having first and second sides, a sample-receiving end and a meter insertion end, and a central longitudinal axis extending between the two ends, the method comprising:
- (a) providing a web of base substrate material having first and second web edges;
(b) forming an electrode set on the web comprising a working electrode and a counter electrode;
(c) applying a stripe of reagent material to the web and covering at least one electrode of the electrode set with the stripe, the stripe being oriented substantially parallel to the first web edge; and
(d) laminating a web of spacing material on top of the base substrate material and providing a cavity in the spacing material such that the electrode set is received within the cavity and the cavity at least partially defines a sample receiving chamber;
(e) aligning and then laminating a web of covering layer material over the web of base substrate and spacing material; and
(f) cutting a test strip from the laminated web produced from steps (a)-(e), the cutting defining the first and second sides of the test strip, wherein the test strip comprises a reagent layer extending to the first and second sides of the test strip under the spacing layer.
6 Assignments
0 Petitions
Accused Products
Abstract
A test strip having a small sample-receiving chamber on the order of less than 1 microliter. The inventive test strip includes a reagent layer that extends across the width of the test strip and also extends to the sample-receiving end, such that the edges of the reagent layer are aligned with the side and dose receiving edges of the test strip. The hydrophilic reagent extending to the dosing edge of the strip promotes wicking of the sample into the test strip. The end and side edges of the reagent layer are preferably formed as part of a cutting process that forms individual test strips from a larger web, which results in a smooth and thin reagent layer with a uniform thickness, substantially covering the entire floor of the sample-receiving chamber. The inventive mass production process helps improve the reproducibility of the quantity, location, thickness and other properties of the reagent layer, which in turn improves the accuracy of the test result.
486 Citations
27 Claims
-
1. A method of manufacturing a test strip having first and second sides, a sample-receiving end and a meter insertion end, and a central longitudinal axis extending between the two ends, the method comprising:
-
(a) providing a web of base substrate material having first and second web edges; (b) forming an electrode set on the web comprising a working electrode and a counter electrode; (c) applying a stripe of reagent material to the web and covering at least one electrode of the electrode set with the stripe, the stripe being oriented substantially parallel to the first web edge; and (d) laminating a web of spacing material on top of the base substrate material and providing a cavity in the spacing material such that the electrode set is received within the cavity and the cavity at least partially defines a sample receiving chamber; (e) aligning and then laminating a web of covering layer material over the web of base substrate and spacing material; and (f) cutting a test strip from the laminated web produced from steps (a)-(e), the cutting defining the first and second sides of the test strip, wherein the test strip comprises a reagent layer extending to the first and second sides of the test strip under the spacing layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
-
-
18. A method of manufacturing a test strip, comprising:
-
(a) providing a web of base substrate material; (b) forming a plurality of sets of measuring electrodes on the web, each set comprising a working electrode and a counter electrode; (c) applying a continuous stripe of reagent material to the web such that said continuous stripe covers each of said plurality of sets of measuring electrodes; (d) providing a web of spacing material defining a plurality of capillary channels; (e) laminating the web of spacing material to the base substrate material such that each capillary channel at least partially overlays a set of electrodes; (f) laminating a web of covering material to the spacing material to cover each of said capillary channels and thereby to define a plurality of capillary spaces; wherein steps (a)-(f) provide a web of test strips, with each test strip comprising a base substrate, a set of measuring electrodes, a reagent layer, a spacing layer, a covering layer, and a capillary space, wherein the reagent layer extends under the spacing layer to the two edges of the base substrate and is sandwiched between the spacing layer and the base substrate; and (g) separating the individual test strips from the web. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26)
-
-
27. A method of manufacturing a test strip, comprising:
-
(a) providing a web of base substrate material; (b) forming a series of sets of measuring electrodes on the web, each set comprising a working electrode and a counter electrode; (c) applying a continuous stripe of reagent material to the web such that said reagent stripe covers each of said series of sets of measuring electrodes; (d) providing a web of covering material defining with the base substrate material a series of capillary channels; (e) laminating the web of capillary-defining material to the web of base substrate material such that each capillary channel at least partially overlays one set of measuring electrodes; wherein steps (a)-(e) provide a web of test strips, with each test strip comprising a base substrate, a set of measuring electrodes, a reagent layer, and a capillary channel, wherein the reagent layer extends under the covering material to the two edges of the base substrate and is sandwiched between the covering material and the base substrate; and (f) separating the individual test strips from the web.
-
Specification