Kit and method for detecting food allergies

• US 6,818,181 B2
• Filed: 03/15/2001
• Issued: 11/16/2004
• Est. Priority Date: 03/15/2001
• Status: Expired due to Fees

• Current Assignee: Savyon Diagnostics Limited
• Original Assignee: Savyon Diagnostics Limited
• Inventors: Lee, Martin Jerome
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US09/808,039
• Publication Number:
  US 20020131893A1
• Time in Patent Office: 1,342 Days
• Field of Search: 422/61, 422/68.1, 422/69, 422/100, 422/58, 422/50, 422/55, 422/56, 422/99, 436/518, 436/164, 436/169, 436/177, 436/178
• US Class Current: 422/412
• CPC Class Codes: G01N 2800/02 Nutritional disorders
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The invention concerns a home kit and a method for detection of food allergies by determining the presence of antibodies against specific antigens in a stool sample.

Claims

1. A home and/or doctor'"'"'s office test kit for detection of a food allergy in an individual, the kit comprising:

(a) a vessel for mixing a stool specimen with a diluting liquid to produce a diluted stool specimen;

(b) a housing separate from said vessel and holding therewithin a substrate,

the substrate comprising at least one zone containing food antigens,

the housing further comprising reagents for producing a visually detected reaction when an antibody-food antigen complex is formed,

the housing further comprising at least one conveying means for receiving diluting stool specimen and transferring it to the food-antigen containing zone of the substrate;

(c) wherein the housing further comprises an indicator for showing the presence of the visually detected reaction for the presence of antibodies against food antigens.

2. A kit according to claim 1, wherein the food antigens are immobilized on the substrate in the zone containing the food antigens.

3. A kit according to claim 1, wherein the substrate has a capillary structure and the conveying means are the capillary forces of the substrate.

4. A kit according to claim 1, wherein the substrate has a porous structure and the conveying means are the absorbent forces of the substrate.

5. A kit according to claim 1, wherein the substrate is selected from:

nitrocellulose sheets, paper, gel-films, cellulose acetate, glass fibers, glass papers, and agarose gel.

6. A kit according to claim 1, wherein the indicator is an opening in a housing showing above the zone of the substrate containing the food antigens.

7. A kit according to claim 1, wherein the diluting liquid is selected from distilled water, formalin solution, sodium acetate solution, sodium acetate solution with a detergent.

8. A kit according to claim 1, wherein the visually detected reaction is obtained by binding of an anti-human antibody, conjugated to a detectable label, to antibody-food antigen complex.

9. A kit according to claim 8, wherein the anti-human antibody is conjugated to a gold particle.

10. A kit according to claim 8, wherein the anti-human antibody is conjugated to an enzyme capable in the presence of a suitable substrate, to produce a visually detected reaction.

11. A kit according to claim 1, for the detection of a single food allergy.

12. A kit according to claim 1, for the. detection of two or more food allergies, wherein each antigen for the detection of the food allergy, is immobilized on a separate zone on the substrate, and wherein each indicator is an opening in the housing above said separate zone.

13. A kit according to claim 1, further comprising a scooping device.

14. A kit according to claim 13, wherein the scooping device is an integral part of a cap for the vessel.

15. A kit according to claim 1, further comprising a disposable container for collecting stools.