Test device for the detection and determination of glucose

• US 4,298,688 A
• Filed: 08/20/1979
• Issued: 11/03/1981
• Est. Priority Date: 07/25/1978
• Status: Expired due to Term

• Current Assignee: Veb Arzneimittelwerk Dresden
• Original Assignee: Veb Arzneimittelwerk Dresden
• Inventors: Kallies, Karl-Heinz
• Primary Examiner(s): Warden, Robert J.
• Application Number:
  US06/068,323
• Time in Patent Office: 806 Days
• Field of Search: 435/14, 435/28, 435/805, 435/25, 422/56, 422/57, 422/58, 422/59, 422/60
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

A test strip for the detection and determination of glucose in body fluids comprising a carrier demarcated into three zones (a) a measuring zone which is untreated, but may be impregnated with a coloring agent, oxidizing agent, buffer or precipitating agent, (b) a reaction zone containing glucose oxidase and (c) a detection zone composed of at least one strip containing peroxidase and an indicator. The paper test strip is preferably enclosed within a suitably dimensioned capillary tube which contains markings at the end thereof enclosing the measuring zone for limiting the amount of flow liquid to be admitted and additional markings at the end thereof enclosing the detection zone for quantitatively reporting the glucose content.

Claims

1. A test strip for the detection and determination of the concentration of glucose in samples of body fluids containing in addition Albumin, blood pigments or Vitamin C as interferants comprising, a carrier strip capable of transporting fluid therealong and which is separated into three zones arranged one above the other in the order indicated:

(a) a measuring zone for receiving a predetermined amount of the test sample impregnated with at least one member of the group consisting of marking agents, coloring agents, oxidation agents, buffers and precipitating agents for binding and elimination of interferants, (b) a reaction zone containing glucose oxidase that will catalyze the oxidation of a glucose substiate, and (c) a detection zone containing peroxidase and an indicator for providing a visible response for accurately determining the level of glucose in the test sample.

2. A test strip according to claim 1, wherein said glucose oxidase is applied to said carrier in an acid solution below its isoelectric point.

3. A test strip according to claim 1, wherein said detection zone is composed of a plurality of indicator stripes containing peroxidase and indicator separated one from the other by untreated stripes.

4. A test device for the detection and determination of glucose in samples of body fluids comprising a test strip according to claim 1, enclosed within a capillary tube open at both ends thereof, bearing markings at the end thereof adjacent the measuring zone for measuring a predetermined amount of flow liquid to be admitted and additional markings at the other end thereof adjacent the detection zone for use in quantitatively reporting the glucose content in the sample of fluid analyzed.

5. A test device according to claim 4, wherein said glucose oxidase is applied to said carrier in an acid solution below its isoelectric point.

6. A test device according to claim 4, wherein in said test strip the detection zone is composed of a plurality of indicator stripes containing peroxidase and indicator separated one from the other by untreated stripes.

7. A test device according to claim 4, wherein in said test strip the detection zone is composed of indicator stripes containing peroxidase and indicator separated one from the other by intermediate stripes which contain a pigment binding agent.

8. A test device according to claim 4, wherein in said test strip the measuring zone and reaction zone are separated by a safety clearance zone containing at least one member of the group consisting of coloring agents, buffers and masking agents.

9. A test device according to claim 4, wherein in said test strip the reaction zone and detection zone are separated by at least one buffer impregnated safety clearance zone.

10. A test device according to claim 4, wherein said capillary tube has an inner diameter of 1-3 mm, a length of 40-120 mm and is made of glass or a glass clear plastic.

11. A test device according to claim 10, wherein said capillary tube has an inner diameter of 2.5 mm and a length of 60 mm.