Diagnostic test carrier

• US 5,096,836 A
• Filed: 09/19/1990
• Issued: 03/17/1992
• Est. Priority Date: 06/27/1987
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Becker, Norbert, Hungenberg, Klaus D., Macho, Heinz K.
• Primary Examiner(s): Johnston, Jill
• Application Number:
  US07/587,168
• Time in Patent Office: 545 Days
• Field of Search: 422/56-58, 436/169, 436/170, 427/2, 156/167, 156/291, 156/295
• US Class Current: 436/169
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements

Abstract

At least two layers are fixed together at a distance so that a gap is present between them, wherein the layers are connected with one another by a plurality of discrete melt adhesive regions, intermediate spaces being present between the melt adhesive regions so that a liquid transport in the gap between the layers is assured through the intermediate spaces. To produce this test carrier, the melt adhesive in the form of discrete regions, between which intermediate spaces are present, is applied to a first layer material in a thickness which is greater than the desired gap and a second layer material is pressed against the melt adhesive regions while the melt adhesive is still sufficiently hot in order to be bindable in such a manner that it binds with the melt adhesive but a gap remains between the layer materials.

Claims

1. A test carrier for determining analyte in a fluid sample, said test carrier comprising

a sample application zone comprising a first layer and a second layer and a gap between said first and second layers, said first and second layers being non-absorbent,

an evaluation zone comprising a first layer and a second layer and a gap between said first and second layer, at least one of said layers being non-absorbent,

said first and second layers in both of said zones being connected together by a plurality of discrete melt adhesive means having a thickness, said adhesive means positioned between said first and second layers so as to provide a plurality of intermediate spaces between said first and second layers, said intermediate spaces having a vertical dimension defining said gap separating said first and second layers, said vertical dimension being defined by the thickness of the melt adhesive means, said gap being dimensioned to assure a capillary action so that said fluid sample can spread out parallel to said first and second layers in a liquid transport path,

said liquid transport path formed by said first and second layers in said sample application and said first and second layers in said evaluation zone, said transport path being parallel to said layers and extending through both of said zones.

2. The test carrier of claim 1, wherein said adhesive means have a thickness of from 0.02 to 1.0 mm.

3. The test carrier of claim 1, wherein said adhesive means have a thickness of from 0.02 to 0.3 mm.

4. The test carrier of claim 1, wherein said adhesive means are adhesive particles.

5. The test carrier of claim 1, wherein said particles have an average surface area of from 0.03 to 5.0 mm².

6. The test carrier of claim 1, wherein said adhesive means comprise a total surface area of for 10 to 70% of the surface area of the layers connected thereby.

7. The test carrier of claim 1, wherein said adhesive means comprise a total surface area of from 15 to 50% of the surface area of the layers connected thereby.

8. Method for determining an analyte in a liquid sample comprising contacting said sample to a device of claim 1, wherein at least one of said layers contains a reagent means which produces a detectable signal in the presence of said analyte, and detecting said signal as an indication of said analyte.

9. Method of claim 8, wherein said liquid sample is whole blood.