Method of making a test strip having a dialyzed polymer layer

• US 5,128,171 A
• Filed: 06/26/1990
• Issued: 07/07/1992
• Est. Priority Date: 05/22/1987
• 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): Housel, James C.
• Assistant Examiner(s): ALEXANDER, LYLE
• Application Number:
  US07/544,251
• Time in Patent Office: 742 Days
• Field of Search: 422/55-58, 436/169-170, 436/14, 436/63, 435/805, 427/2
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control

Abstract

A test strip for the detection of a predetermined substance in a fluid is described. This test strip is stable to storage and accelerated keeping test conditions and comprises a support having thereof a reagent layer wherein the reagent layer contains a dialyzed latex polymer and a reagent detection system which reacts with the substance to provide a detectable change.

Claims

1. A method for making a test strip for the detection of a predetermined substance, the method comprising:

dialyzing a predetermined amount of latex polymer to permit low molecular weight species, unreacted monomer, catalyst, and surfactant to pass through a dialysis membrane to provide a dialyzed latex polymer;

mixing the dialyzed latex polymer with a reagent detection system for detecting the predetermined substance wherein the dialyzed latex polymer constitutes at least 60% by weight of the dry mixture;

coating the mixture on a support;

heating the coating support to form a dry reagent layer; and

cutting the coated support into strips of the desired size.

2. The method of claim 1 wherein the latex polymer contains a carboxylated polyvinyl acetate/ethylene copolymer.

3. The method of claim 1 wherein the dialyzedlatex polymer constitutes at least 75% by weight of the dry reagent layer.

4. The method of claim 1 wherein the reagent detection system contains a reagent that undergoes a visible change when the test strip is contacted with a fluid containing the predetermined substance.

5. The method of claim 4 wherein the reagent undergoes a change of color to indicate the presence of the predetermined substance.

6. The method of claim 1 wherein the reagent detection system contains reagents for detecting glucose.

7. The method of claim 6 wherein the reagent detection system contains a reagent that undergoes a visible change when the test strip is contacted with a fluid containing glucose.

8. The method of claim 7 wherein the reagent undergoes a change of color to indicate the presence of glucose.

9. A method for making a test strip for the detection of glucose, the method comprising:

dialyzing a predetermined amount of carboxylated vinylacetate/ethylene copolymer;

mixing the dialyzed copolymer with glucose oxidase, peroxidase, and a color indicator that changes color when the mixture is exposed to glucose, the mixture constituting at least 60% dialyzed copolymer by weight of the dry mixture;

coating the mixture on a support;

heating the coated support to form a dry reagent layer; and

cutting the coated support into strips of the desired size.