Kit and method for detecting fecal parasites

• US 6,596,502 B2
• Filed: 03/15/2001
• Issued: 07/22/2003
• Est. Priority Date: 03/15/2001
• Status: Expired due to Fees

• Current Assignee: Savyon Diagnostics Limited
• Original Assignee: Lee Research Laboratory, Inc.
• Inventors: Lee, Martin Jerome
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/808,017
• Publication Number:
  US 20020132270A1
• Time in Patent Office: 859 Days
• Field of Search: 436/514, 436/518, 436/528, 436/808, 436/810, 436/825, 435/7.22, 435/7.1, 435/7.94, 435/288.1, 435/962, 435/970, 435/975, 422/56, 422/58, 422/61, 422/102
• US Class Current: 435/7.22
• CPC Class Codes: G01N 2333/44 from protozoa
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/56905 Protozoa
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample

Abstract

The invention concerns a home kit and a method for detection of the presence of a fecal parasite in a stool.

Claims

1. A home and/or doctor'"'"'s office test kit for detection of the presence of two or more fecal protozoan parasites in a stool sample, the kit comprising:

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

(b) a housing holding within a substrate, the substrate comprising at least two separate zones containing antibodies against the parasites to be detected, the housing further comprising reagents for producing a visually detectable reaction when an antibody-parasite antigen complex is formed, the housing further comprising at least one conveying means for receiving diluted stool specimen and transferring it to the antibody containing zones of the substrate;

(c) the housing further comprises at least one means for viewing the result of the antigen-antibody reaction;

wherein the parasites are selected from the group consisting of Amoeba histolytica, Amoeba hartmanni, Amoeba coli, Amoeba nana, Giardia lamblia, Cryptosporidium sp., Blastocystis hominis, Chilomastix mesnili, Lodamoeba butschlii, and Dientamoeba fragillis.

2. The kit according to claim 1, wherein the antibodies are immobilized on the substrate.

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

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

5. The kit according to claim 1, wherein the substrate is selected from the group consisting of nitrocellulose sheets, paper, gel-films, cellulose acetate, glass fibers, glass papers, and agarose gel.

6. The kit according to claim 1, wherein the at least one means for viewing is an opening in the housing above the antibodies-containing zones.

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

8. The kit according to claim 1, wherein the visually detectable reaction is obtained by binding of an antibody directed against the parasite to be detected, a component shed or secreted from the parasite reaction is obtained by binding of an antibody directed against the parasite to be detected, a component shed or secreted from the parasite, immunogenic epitopes of the parasites and combination thereof, the antibodies are conjugated to a detectable label to form an antibody-parasite antigen complex.

9. The kit according to claim 8, wherein detectable label is a gold particle.

10. The kit according to claim 8, wherein the detectable label is an enzyme capable in the presence of a suitable substrate, to produce a visually detected reaction.

11. The housing according to claim 1, comprising a plurality of means for viewing, each of said means is an opening in the housing above each of said separate zones.

12. The kit according to claim 1, wherein the antibodies are polyclonal antibodies.

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

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

15. The kit according to claim 1, further comprising a disposable container for collecting a stool sample.

16. A method for detecting the presence of two ore more fecal protozoan parasites in a stool sample, the method comprising:

(a) obtaining a stool specimen;

(b) diluting the stool specimen with a diluting liquid to produce a diluted stool specimen;

(c) introducing the stool specimen into a housing in the kit according to claim 1; and

(d) detecting the presence or absence of the parasite in the stool specimen by observing the result of the antigen-antibody reaction.

17. The method according to claim 16, for detecting fetal parasites in an animal stool sample.

18. The method according to claim 17, wherein the animal is human.

19. The kit according to claim 1 wherein the substrate of the housing comprises a plurality of zones containing antibodies against all of the following parasites, each zone containing antibodies against one of the parasites:

Amoeba histolytica, Amoeba hartmanni, Amoeba coli, Amoeba nana, Giardia lamblia, Cyptosporidium sp., Blastocystis hominis, Chilomastix mesnili, lodamoeba butschlii, and Dientamoeba fragillis.

20. The method according to claim 16 wherein the substrate of the housing of the kit in step (c) comprises a plurality of zones containing antibodies against all of the following parasites, each zone containing antibodies against one of the parasites:

Amoeba histolytica, Amoeba hartmanni, Amoeba coli, Amoeba nana, Giardia lamblia, Cryptosporidium sp., Blastocystis hominis, Chilomastix mesnili, lodamoeba butschlii, and Dientamoeba fragillis.