Devices and methods for collecting fecal antigen specimens

• US 6,063,038 A
• Filed: 04/09/1999
• Issued: 05/16/2000
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: CLMP, Inc.
• Original Assignee: CLMP, Inc.
• Inventors: Stark, William A., Diamond, Ronald N., Miller, Phillip C.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/289,158
• Time in Patent Office: 403 Days
• Field of Search: 600/562, 600/569, 600/572, 600/576
• US Class Current: 600/569
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: G01N 1/4077 by other techniques involving separation of suspended solids

Abstract

A fecal antigen specimen tube apparatus preferably consists of a 16×75 mm screw-top specimen tube and a special screw cap assembly. The screw cap has a hollow "straw" with a specimen collection brush on the end. The screw-cap assembly can be removed from the specimen tube so that the brush end may be dipped into a fecal sample and rotated to collect a specimen. The cap assembly with specimen is then screwed back into the specimen tube to seal the container. The straw preferably has a number of openings along its length, which permits fluid to move back and forth through the straw as the specimen tube is agitated. Filters with pore sizes of approximately 100 microns are disposed over the openings to prevent larger pieces of fecal matter from penetrating into the straw. The filter, however, will permit most parasites to pass into the straw. The top of the straw (and cap assembly) is preferably sealed with a heat-seal film. This film seals the specimen tube, preventing spillage and evaporation. The film can be penetrated by a sample probe of an automated instrument for removal of a portion of the liquid during the analytical process. After specimen processing, the tube may be resealed with tape or disposed of. Advantageously, then, the inventive device permits semi-automated specimen processing, which provides for a complete system from specimen collection to introduction on automated immunodiagnostic instruments.

Claims

1. A fecal specimen collection apparatus, comprising:

a tube having a sidewall;

a cap assembly adapted for insertion into the tube, the cap assembly comprising a cap and a straw portion extending downwardly from said cap;

a fecal specimen collection element disposed on a lower end of said straw portion; and

a filter disposed on a lower end of said straw portion.

2. The fecal specimen collection apparatus as recited in claim 1, wherein said straw portion is hollow and comprises a sidewall defining an interior volume.

3. The fecal specimen collection apparatus as recited in claim 2, and further comprising at least one opening disposed on said straw portion sidewall.

4. The fecal specimen collection apparatus as recited in claim 3, wherein said filter is disposed on said straw portion sidewall over said at least one opening.

5. The fecal specimen collection apparatus as recited in claim 3, wherein said filter comprises said at least one opening.

6. The fecal specimen collection apparatus as recited in claim 1, wherein said fecal specimen collection element comprises a brush.

7. The fecal specimen collection apparatus as recited in claim 6, wherein said fecal specimen collection element further comprises a bracket disposed on a lower end of said straw portion, said brush being connected to said bracket.

8. The fecal specimen collection apparatus as recited in claim 2, and further comprising a top opening on said straw portion, said top opening being sealed by a puncturable film.

9. The fecal specimen collection apparatus as recited in claim 1, wherein said tube and tube sidewall are cylindrical.

10. The fecal specimen collection apparatus as recited in claim 2, wherein said cap assembly is removable from said tube as a single unit for collecting a fecal specimen, and then reinsertable into said tube to mix the fecal specimen with reagent contained in the tube.

11. A fecal specimen collection apparatus, comprising:

a tube having a sidewall;

a cap assembly adapted for insertion into the tube, the cap assembly comprising a cap hollow and a straw portion comprising a sidewall defining an interior volume, and extending downwardly from said cap, an upper end of the said straw portion extending through said cap;

a fecal specimen collection element disposed on a lower end of said straw portion;

a top opening disposed on an upper end of the straw portion, at a top end of said cap; and

a puncturable film disposed over said top opening.

12. The fecal specimen collection apparatus as recited in claim 11, wherein said puncturable film comprises a plastic film.

13. The fecal specimen collection apparatus as recited in claim 12, wherein said plastic film is sealed over said opening.

14. The fecal specimen collection apparatus as recited in claim 11, wherein said apparatus comprises a filter portion disposed on said sidewall.

15. The fecal specimen collection apparatus as recited in claim 14, wherein the filter portion has holes which are sufficiently small to prevent larger fecal pieces from entering the interior volume of the straw portion, but are sufficiently large to permit most parasites to enter the interior volume of the straw portion.

16. The fecal specimen collection apparatus as recited in claim 15, wherein said holes are sized within a range of 50-150 microns in diameter.

17. The fecal specimen collection apparatus as recited in claim 15, wherein said holes are approximately 100 microns in diameter.

18. The fecal specimen collection apparatus as recited in claim 14, wherein the filter portion comprises a precision woven plastic mesh material.

19. The fecal specimen collection apparatus as recited in claim 14, wherein said filter portion comprises a plurality of holes disposed in the sidewall of said straw portion.

20. The fecal specimen collection apparatus as recited in claim 14, wherein said sidewall includes a plurality of holes disposed therein, and said filter portion is disposed over said plurality of holes.

21. The fecal specimen collection apparatus as recited in claim 11, wherein said fecal specimen collection element comprises a brush.

22. The fecal specimen collection apparatus as recited in claim 19, wherein said fecal specimen collection element further comprises a bracket disposed on a lower end of said straw portion, said brush being connected to said bracket.

23. A fecal specimen collection apparatus, comprising:

a tube having a sidewall;

a cap assembly adapted for insertion into the tube, the cap assembly comprising a cap and a straw portion extending downwardly from said cap, the straw portion comprising a sidewall defining a hollow interior; and

a filter disposed on said straw portion sidewall.

24. The fecal specimen collection apparatus as recited in claim 23, wherein said filter comprises a plurality of holes disposed in said straw portion sidewall.

25. The fecal specimen collection apparatus as recited in claim 23, wherein said straw portion sidewall comprises at least one hole therein, and said filter is disposed over said at least one hole.

26. A method for collecting and analyzing a fecal specimen using an apparatus which comprises a tube having a sidewall and a cap assembly removably attachable to said tube, the cap assembly comprising a cap and a straw portion extending through and downwardly from said cap, the straw portion having a sidewall which defines an interior volume, and a specimen collection element disposed on a lower end of the straw portion, said method comprising the steps of:

inserting the cap assembly into a fecal sample so that a fecal specimen is collected by said specimen collection element;

inserting the cap assembly into said tube;

sealingly securing the cap assembly to said tube, so that liquid contained in said tube and in said straw portion cannot escape from the apparatus;

agitating the apparatus so that liquid reagent contained in said tube is mixed with said fecal specimen; and

inserting a probe into said straw portion without removing the cap assembly from the tube, for removing a portion of the mixed liquid contained in said straw portion for analysis.

27. The method as recited in claim 26, and further comprising removing the cap assembly from the tube prior to inserting it into the fecal sample.

28. The method as recited in claim 26, wherein the agitating step further comprises filtering said liquid reagent and fecal specimen mixture so that fecal solids introduced into the straw portion are not of excessive size.

29. The method as recited in claim 26, wherein the straw portion further includes a top opening which is covered by a sealing film, and the probe insertion step comprises puncturing the film with a distal end of the probe so that the probe enters the straw portion through said film.

30. The method as recited in claim 29, and further comprising the step of withdrawing the probe after obtaining a suitable portion of the mixed liquid contained in the straw portion, and the further step of re-sealing said top opening after withdrawing the probe, thereby preserving the portion of mixed liquid remaining in the straw portion for future analysis.