Test device for detecting glucose, protein urobilinogen, and/or occult blood in body fluids and/or determining the PH thereof

• US 5,183,742 A
• Filed: 05/08/1989
• Issued: 02/02/1993
• Est. Priority Date: 02/24/1984
• Status: Expired due to Fees

• Current Assignee: Dai Nippon Printing Company Limited
• Original Assignee: Dai Nippon Printing Company Limited
• Inventors: Omoto, Kouichi, Miyazaki, Takeshi
• Primary Examiner(s): Kepplinger, Esther L.
• Assistant Examiner(s): Spiegel, Carol A.
• Application Number:
  US07/349,950
• Time in Patent Office: 1,366 Days
• Field of Search: 422/56, 422/55, 422/57, 422/58, 436/136, 436/826, 436/168, 436/170, 436/86, 436/163, 435/4, 435/14, 435/23, 435/25, 435/28, 435/805, 424/6, 424/71, 424/78
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 436/826 Additives, e.g. buffers, diluents, preservatives
• CPC Class Codes: Y10T 436/207497 Molecular oxygen

Abstract

A test device having the following meritorious effects is obtained in accordance with the present invention by using at least one composition selected from the group consisting of ink compositions for detecting glucose, for detecting protein, for detecting urobilinogen, and for detecting occult blood in a body fluid, and for detecting the pH thereof:

a) The test device is stable during storage in atmospheric air for a long period of time, presenting no discoloration phenomenon;

b) The test device has high sensitivity coupled with excellent measurement performance;

c) The regions for detecting glucose and the other body fluid ingredients and the pH can be formed directly on the surface of the test device by printing, allowing the test device to be formed by mass production and the process steps to be reduced; and

d) The ink compositions for detecting glucose, etc. are stable, and can be handled easily.

Claims

1. A test device for body fluids comprising a support having printed or coated on a surface thereof at least one detection region, each detection region comprising a reagent composition selected from the group of reagent compositions consisting of:

(a) a glucose detection reagent comprising a glucose oxidase, peroxidase, a peroxide oxidizable indicator, a glucose detection reagent binder and a color stabilizer which stabilizes said peroxide oxidizable indicator and a detectable product, said reagent being dissolved or dispersed in a nonaqueous solvent for the glucose detection reagent, said solvent excluding C₁ to C₂ alcohols;

(b) a protein detection reagent comprising a pH indicator, a pH buffer, a protein-adsorptive ion exchanger, and a protein detection reagent binder, said reagent being dissolved or dispersed in a non-aqueous solvent for the protein detection reagent; and

(c) a pH determination reagent comprising a pH indicator, and a pH determination reagent binder, said reagent being dissolved or dispersed in a non-aqueous solvent for the pH determination reagent; and

at least one water-retentive pattern portion formed on said surface of said support between and coplanar with each of said detection regions such that adjacent detection regions are separated by at least one water-retentive pattern portion;

wherein said support is nonadsorptive, the water retentive pattern portions have a capacity of absorbing water of at least 10 times their own weight, and spaces are provided on said support between each of said detection regions and each of said water-retentive pattern portions.

2. The test device as claimed in claim 1, wherein the oxidizable indicator in the glucose detection reagent comprises either a chromogen or a chromogen and a coupling agent.

3. The test device as claimed in claim 1, wherein the color stabilizer in the glucose detection reagent is a tocopherol or a glycerol ester.

4. The test device as claimed in claim 1, wherein the protein-adsorptive ion exchanger in the protein detection reagent is an acidic cation exchanger having as a functional group a carboxyl group, and the protein detection composition binder is a maleic acid ester copolymer.

5. The test device as claimed in claim 1, wherein the pH determination reagent binder comprises hydroxy ethylcellulose or a polyvinyl pyrrolidone, both of which are water-soluble polymers which do not impede color formation of the pH indicator, and a urethane resin or a polyvinyl butyral resin which is a water-insoluble polymer capable of effectively preventing the elution of the pH determination reagent into an applied body fluid.