TEST STRIP WITH SLOT VENT OPENING

• US 20120009095A1
• Filed: 09/20/2011
• Published: 01/12/2012
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Operations Limited (Roche Holding AG)
• Inventors: Burke, David W., Marquant, Michael
• Granted Patent: US 8,211,379 B2
• Time in Patent Office: Days
• US Class Current: 422/430
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 156/1059 Splitting sheet lamina in plane intermediate of faces
• CPC Class Codes: Y10T 156/1084 of continuous or running length bonded web

Abstract

Methods of manufacturing test strips are disclosed. Embodiments include laminating a two piece covering layer over a substrate with a series of cavities, wherein the two pieces are separated by a gap, the gap forming a vent opening for the cavities. Other embodiments include covering the sample receiving chamber with a cover thinner than the cover covering the body of the test strip, the thicker body cover absorbing more force than the chamber cover to reduce the possibility of adhesives squeezing out from under the chamber cover. The present invention also provides an advantageous method of mass-producing the inventive test strips without having to align the slot or vent opening laterally with respect to the test strips and without having to punch a vent opening. The method is also well suited to mass production by roll processing techniques.

Claims

1. A test strip having a width defined between a first edge and a second edge, the test strip comprising:

a base substrate having a reagent layer disposed thereon;

a covering layer overlying the base substrate, the covering layer comprising a chamber cover portion and a body cover portion, the chamber cover portion and the body cover portion having a slot therebetween, the slot extending across the width of the test strip from the first edge to the second edge; and

a sample receiving chamber disposed between the base substrate and the chamber cover portion, the slot being in communication with the sample receiving chamber and defining a vent opening that allows air to escape as fluid enters the sample receiving chamber.

2. The test strip of claim 1, wherein the slot is positioned over the reagent layer.

3. The test strip of claim 1, wherein the slot is substantially straight.

4. The test strip of claim 1, wherein the slot is oriented substantially horizontal and perpendicular to a longitudinal axis of the test strip.

5. The test strip of claim 1 and further comprising:

a spacer layer having a bottom surface and a top surface, the bottom surface of the spacer layer being secured to the top surface of the base substrate, the spacer layer including an opening overlying the top surface of the base substrate and extending from an edge of the test strip to the interior of the test strip, the spacer layer defining a sample receiving chamber and the reagent being located within the sample receiving chamber;

the covering layer being adjacent to the top surface of the spacer layer.

6. A test strip, comprising:

a base substrate having a reagent layer disposed thereon;

a chamber cover connected to the base substrate and overlying the base substrate and the reagent layer;

a body cover connected to and overlying the base substrate, the body cover being horizontally separated from the chamber cover to form a horizontal gap between the body cover and the chamber cover;

a sample receiving chamber disposed between the base substrate and the chamber cover, the gap being in communication with the sample receiving chamber and defining a vent opening that allows air to escape as fluid enters the sample receiving chamber; and

wherein the test strip includes two spaced-apart edges defining a width of the test strip, the gap extending across the full width of the test strip to define a slot extending from one of the edges to the other.