Method for continuous manufacture of diagnostic test strips

• US 5,547,702 A
• Filed: 07/08/1994
• Issued: 08/20/1996
• Est. Priority Date: 07/08/1994
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Polymer Technology Group, Inc. (DSM-Firmenich AG)
• Inventors: Gleisner, John M.
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/272,192
• Time in Patent Office: 774 Days
• Field of Search: 427/2.13, 427/285, 427/286, 427/414, 427/338, 422/56, 422/57, 435/4, 435/7.1, 435/7.71, 435/7.9, 435/7.91
• US Class Current: 427/2.13
• CPC Class Codes: G01N 33/521 Single-layer analytical elements

Abstract

A method for making a test strip is described. The test strip is generally a substrate, a layer disposed on the substrate and located near the distal end of the substrate. The layer typically contains a chemical reagent detection system capable of detecting the presence of a predetermined analyte in a sample of biological fluid, wherein the reagent detection system produces a detectable change in the layer in the presence of the analyte. In the method, a length of substrate is provided having a width substantially the dimension of the final length of the test strip being made; on the substrate near one edge thereof is provided a layer of material permeable to biological fluids, the layer having a width sufficient to place thereon a drop of biological fluid for treating; to the layer of permeable material is continuously applied an aqueous solution containing reagent detection chemicals capable of providing a detectable change in the presence of a predetermined analyte, the solution being applied in an amount to substantially saturate the permeable material; the layer of permeable material is dried to contain the reagent detection chemicals within the layer; and the web is cut into predetermined shorter lengths containing a preset number of test strips for further processing.

Claims

1. A method for making a test strip comprising a substrate, a layer disposed on the substrate and located adjacent the distal end of the substrate, said layer containing a chemical reagent detection system capable of detecting the presence of an analyte in a sample of biological fluid, the reagent detection system producing a detectable change in said layer in the presence of said analyte, said method comprising:

providing a web comprising a length of substrate having a width substantially the dimension of a final length of the test strip being made;

providing on said substrate adjacent to one edge thereof a layer of material permeable to biological fluids, said layer having a width sufficient to place thereon a drop of biological fluid;

continuously applying to the layer of permeable material an aqueous solution containing reagent detection chemicals capable of providing the detectable change in the presence of the analyte, said solution being applied in an amount to substantially saturate the permeable material;

drying the layer of permeable material to contain the reagent detection chemicals within said layer; and

cutting the web into shorter lengths of web containing a plurality of test strips for further processing.

2. The method of claim 1 wherein the reagent detection chemicals comprise glucose oxidase, peroxidase and an indicator.

3. The method of claim 2 wherein the indicator is a dye couple consisting of 3-dimethylaminobenzoic acid and 3-methyl-2-benzothiazolinone hydrazone.

4. The method of claim 1, further comprising cutting each shorter length of web into individual test strips and packaging the plurality of test strips in a sealed container.

5. A method for making a test strip comprising a substrate, a layer disposed on the substrate and located adjacent the distal end of the substrate, said layer containing a chemical reagent detection system capable of detecting the presence of an analyte in a sample of biological fluid, the reagent detection system producing a detectable change in said layer in the presence of said analyte, said method comprising:

providing a web comprising a length of substrate having a width substantially the dimension of a final length of the test strip being made;

providing on said substrate adjacent to one edge thereof a layer of material permeable to biological fluids, said layer having a width sufficient to place thereon a drop of biological fluid;

continuously applying to the layer of permeable material a first solution containing an indicator capable of providing the detectable change in the presence of the analyte, said first solution being applied in an amount to substantially saturate the permeable material;

drying the layer of permeable material to contain the indicator within said layer;

continuously applying to the layer of permeable material a second solution comprising an aqueous solution containing enzymes capable of reacting with the analyte to provide a response that produces the detectable change to the indicator, said second solution being applied at a rate to provide a quantity of enzymes in the permeable layer;

drying the layer of permeable material to contain the enzymes within said layer; and

cutting the web into shorter lengths of web containing a plurality of test strips for further processing.

6. The method of claim 5 wherein the first solution comprises an indicator dissolved in a mixture of water and a water miscible organic solvent.

7. The method of claim 6 wherein the indicator is a dye couple consisting of 3-dimethylaminobenzoic acid and 3-methyl-2-benzothiazolinone hydrazone.

8. The method of claim 5 wherein the second aqueous solution comprises a solution of glucose oxidase and peroxidase.

9. The method of claim 5 wherein the first solution comprises an indicator dissolved in a mixture of water and a water miscible organic solvent and the second aqueous solution comprises a solution of glucose oxidase and peroxidase.

10. The method of claim 9 wherein the indicator is a dye couple consisting of 3-dimethylaminobenzoic acid and 3-methyl-2-benzothiazolinone hydrazone.

11. The method of claim 5, further comprising cutting each shorter length of web into individual test strips and packaging the plurality of test strips in a sealed container.