Device for testing body fluids

• US 5,178,831 A
• Filed: 08/15/1991
• Issued: 01/12/1993
• Est. Priority Date: 10/08/1986
• Status: Expired due to Term

• Current Assignee: DAI Nippon Insatsu Kabushiki Kaisha
• Original Assignee: DAI Nippon Insatsu Kabushiki Kaisha
• Inventors: Kondo, Junichi, Watanabe, Masanao, Sakota, Kazuyuki
• Primary Examiner(s): Johnston, Jill A.
• Application Number:
  US07/746,190
• Time in Patent Office: 516 Days
• Field of Search: 422/55-58, 436/169, 436/170, 436/164, 435/805, 435/970
• US Class Current: 422/421
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

A device for testing body fluids includes (a) a test reagent layer (1) formed on a substrate (5) and containing a test reagent, the tone of which changes according to the content of a test-objective material in a solution to be tested, and (b) a tone layer for criterion (3) formed on the substrate (5) and having a color formed by a dye or the like. The tone layer is used in order to judge the hue of the resulting color of the test reagent layer, wherein both the test layer (1) and the tone layer (3) have the property of absorbing the solution to be tested, and the hue of the resulting color of the test reagent layer and the hue of the tone layer can be compared by their wet colors, thereby affording a highly precise body fluid test.

Claims

1. A device for testing aqueous body fluids comprising:

(a) a test reagent layer formed on a substrate and containing a test reagent, a tone of which changes according to a content of test-objective material in an aqueous solution to be tested; and

(b) a tone layer for criterion formed on the substrate and having a color formed by a coloring agent, said tone layer being compared to a hue of a resulting color or said test reagent layer, said tone layer comprising the coloring agent, a binder, and a water-absorptive powder;

both said test reagent layer and said tone layer having a property of absorbing the aqueous solution to be tested, and a capacity of the test reagent layer to absorb the aqueous solution to be tested and a capacity of the tone layer to absorb the aqueous solution to be tested are substantially similar;

wherein the hue of the resulting color of said test reagent layer and the hue of said tone layer are color-compared in their wet state.

2. The device for testing aqueous body fluids according to claim 1, wherein absorption quantities of the aqueous solution to be tested which can be absorbed by the test reagent layer and the tone layer are from 50 to 500% of the respective weights of said layers on a dry basis.

3. The device for testing aqueous body fluids according to claim 2 wherein the absorption quantities are from 100 to 300%.

4. The device for testing aqueous body fluids according to claim 1, wherein said binder comprises a hydrophilic resin, a natural polymeric material or a mixture thereof.

5. The device for testing aqueous body fluids according to claim 1, further comprising a highly water-absorptive portion provided on the substrate.

6. The device for testing aqueous body fluids according to claim 1, wherein the test reagent layer comprises at least one of (a) a composition for glucose detection, (b) a composition for protein detection, and (c) a composition for pH determination.

7. The device for testing aqueous body fluids according to claim 1, wherein the test reagent layer comprises a composition for urobilinogen detection.

8. The device for testing aqueous body fluids according to claim 1, wherein the test reagent layer comprises a composition for urobilinogen detection.

9. The device for testing aqueous body fluids according to claim 1, wherein the test reagent layer and the tone layer are formed with an intervening gap therebetween.

10. The device for testing aqueous body fluids according to claim 9, wherein the gap between the test reagent layer and the tone layer is from 0.2 to 2 mm.

11. A device for testing aqueous body fluids comprising:

(a) a test reagent layer formed on a substrate and containing a test reagent, a tone of which changes according to a content of test-objective material in an aqueous solution to be tested; and

(b) a tone layer for criterion formed on the substrate and having a color formed by a coloring agent, said tone layer being compared to a hue of a resulting color of said test reagent layer, said tone layer comprising the coloring agent, a binder, and a water-absorptive powder, wherein a weight ratio of the water-absorptive powder to the binder is from 100;

3 to 100;

30;

both said test reagent layer and said tone layer having a property of absorbing the aqueous solution to be tested, and a capacity of the tone layer to absorb the aqueous solution to be tested being less than a capacity of the test reagent layer to absorb the aqueous solution to be tested;

wherein the hue of the resulting color of said test reagent layer and the hue of said tone layer are color-compared in their wet state.

12. The device for testing aqueous body fluids according to claim 11, wherein the weight ratio of the water-absorptive powder to the binder is from 100:

5 to 100;

20.

13. A device for testing aqueous body fluids comprising:

(a) a test reagent layer formed on a substrate and containing a test reagent, a tone of which changes according to a content of test-objective material in an aqueous solution to be tested; and

(b) a tone layer for criterion formed on the substrate and having a color formed by a coloring agent, said tone layer being compared to a hue of a resulting color of said test reagent layer, said tone layer comprising the coloring agent, a binder, and a water-absorptive powder selected from the group consisting of inorganic powders, cellulose powders, ion exchange resin powders and mixtures thereof;

both said test reagent layer and said tone layer having a property of absorbing the aqueous solution to be tested, and a capacity of the test reagent layer to absorb to aqueous solution to be tested and a capacity of the tone layer to absorb the aqueous solution to be tested are substantially similar;

wherein the hue of the resulting color of said test reagent layer and the hue of said tone layer are color-compared in their wet state.

14. A device for testing aqueous body fluids comprising:

(a) a test reagent layer formed on a substrate and comprising a test reagent and a wetting agent, a tone of said test reagent layer changes according to a content of test-objective material in an aqueous solution to be tested; and

(b) a tone layer for criterion formed on the substrate and having a color formed by a coloring agent, said tone layer being compared to a hue of a resulting color of said test reagent layer, said tone layer comprising the coloring agent, a binder, and a water-absorptive powder;

both said test reagent layer and said tone layer having a property of absorbing the aqueous solution to be tested, and a capacity of the test reagent layer to absorb the aqueous solution to be tested and a capacity of the tone layer to absorb the aqueous solution to be tested are substantially similar;

wherein the hue of the resulting color of said test reagent layer and the hue of said tone layer are color-compared in their wet state.