Kit and method for detecting fecal parasites

• US 20020132270A1
• Filed: 03/15/2001
• Published: 09/19/2002
• Est. Priority Date: 03/15/2001
• Status: Active Grant

• Current Assignee: Savyon Diagnostics Limited
• Original Assignee: Savyon Diagnostics Limited
• Inventors: Lee, Martin Jerome
• Granted Patent: US 6,596,502 B2
• Time in Patent Office: Days
• US Class Current: 435/7.3
• 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 fecal 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 one zone containing antibodies against the parasite to be detected, the housing further comprising reagents for producing a visually detected reaction when an antibody-parasite antigen complex is formed, the housing further comprising at least one conveying means for receiving diluting stool specimen and transferring it to the anti-parasite antibody containing zone of the substrate;

(c) the housing further comprises an indicator for showing the presence of the visually detected reaction.

2. A kit according to claim 1, wherein the anti-parasite antibodies are immobilized on the substrate in the zone containing the antibodies.

3. A kit according to claim 1, wherein the substrate has 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 anti-parasite antibodies.

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 antibody directed against the parasite to be detected, a component shed or secreted from the parasite or immunogenic epitopes of any of the above, the antibody being conjugated to a detectable label to form an antibody-parasite antigen complex.

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

10. A kit according to claim 8, wherein the conjugated 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 the presence of a single parasite in a stool sample.

12. A kit according to claim 1, for the detection of the presence of two or more parasites in a stool, wherein the antibodies for the detection of one parasite species, 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, for the detection of protozoa parasites.

14. A kit according to claim 13, wherein the parasites are selected from:

15. A kit according to claim 1, wherein the antibodies are polyclonal antibodies.

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

17. A kit according to claim 16, wherein the scooping device is an integral part of a cap for the vessel.

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

19. A method for detecting the presence of a fecal parasite in a stool sample, the method comprising:

(i) obtaining a stool specimen;

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

(iii) introducing the stool specimen into the kit according to claim 1;

and

(iv) viewing the indicator, the presence of a visually detected reaction in the indicator, indicating the presence of the parasite in the stool.

20. A method according to claim 19, for detecting fecal parasites in a human stool sample.

21. A method according to claim 20, for detecting fecal parasites in an animal stool sample.