KIT AND METHOD FOR COLLECTING BODY FLUID FOR MEDICAL DIAGNOSIS

• US 20160273059A1
• Filed: 10/22/2013
• Published: 09/22/2016
• Est. Priority Date: 10/22/2013
• Status: Active Grant

• Current Assignee: Ilex Medical Ltd.
• Original Assignee: Ilex Medical Ltd.
• Inventors: BENSHAUL, Moshe
• Granted Patent: US 11,008,631 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: C12Q 1/708 for papilloma
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

A kit and method for collecting body fluid for medical diagnosis. In some embodiments, the method includes collecting a sufficient amount of body fluid and cells comprising nucleic acid, and applying a nucleic acid assay to detect pathogenic genomic material such as human papillomavirus mRNA and/or human papillomavirus DNA. In some embodiments, by testing fluid and cells, a sensitivity of the test is improved. In some embodiments, the method includes inserting an absorbing member into a body orifice, such as the vagina, for a time period such as 1-2 hours; retrieving the absorbing member and placing it in a sample container; extracting fluid from the absorbing member using a fluid extraction device, and testing the fluid. In some embodiments, the kit is a home use kit and the sample is self collected by a user.

Claims

1. A method for applying a nucleic acid assay comprising:

providing body fluid and cells collected on an absorbing member;

extracting said body fluid and cells by passing said absorbing member through an aperture having a cross section smaller than a cross section of said absorbing member; and

applying a nucleic acid assay to said extracted body fluid and cells to detect pathogenic genomic material.

2. The method according to claim 1, wherein said absorbing member was previously inserted into a body orifice.

3. The method according to claim 1, wherein said pathogenic genomic material comprises at least one of viral genome and bacterial genome.

4. The method according to claim 3, wherein said viral genome includes at least one of human papillomavirus mRNA and human papillomavirus DNA.

5. The method according to claim 1, wherein at least one of body fluid and cells were collected from a vagina.

7. The method according to claim 1, wherein extracting fluid comprises bursting open cells and releasing their content.

8. The method according to claim 1, wherein a fluid extraction device comprising said aperture is used for said extracting fluid and cells.

9. The method according to claim 8, wherein said extracting comprises applying radial pressure on said absorbing member using said fluid extraction device.

10. The method according to claim 8, wherein said extracting comprises applying axial pressure on said absorbing member using said fluid extraction device.

11. The method according to claim 8, wherein said extracting comprises scraping at least a portion of the absorbing member'"'"'s walls to collect cells using said fluid extraction device.

12. The method according to claim 1, wherein passing said absorbing member through said aperture reduces a size of at least a portion of a swollen absorbing member.

13. The method according to claim 8, wherein said extracting fluid comprises attaching said fluid extraction device to a sample container.

14. The method according to claim 13, wherein extracted fluid is collected within said sample container.

15. The method according to claim 14, wherein said extracted fluid blends in a preserving solution within said container, increasing a volume of the liquid.

29. The method according to claim 1, wherein an amount of body fluid and cells collected by said extracting is sufficient to improve a sensitivity of said nucleic acid assay by at least 10% as compared to a sensitivity of a nucleic acid assay performed on cells only.

6. (canceled)

16-17. -17. (canceled)

18. A fluid extraction device for collecting fluid from an absorbing member, said device comprising at least one opening defining an aperture small enough to squeeze said absorbing member as it is passed through said aperture for extracting fluid from said absorbing member;

wherein said device is attachable to a sample container.

19. The fluid extraction device according to claim 18, wherein said device is sized to fit on top of a sample container.

20. The fluid extraction device according to claim 19, wherein said device comprises a threaded opening for attaching the device onto said sample container.

21. The fluid extraction device according to claim 18, wherein said device comprises at least one curvature for channeling extracted fluid into a sample container.

22. (canceled)

23. A method for extracting fluid using a fluid extraction device, comprising passing an absorbing member through an aperture of a fluid extraction device, said aperture small enough to squeeze said absorbing member as it is passed through;

and

collecting extracted fluid which accumulates on at least one wall of the fluid extraction device.

24. A sample container comprising an extracting element, said extracting element forming a passage within said container having an aperture small enough to squeeze an absorbing member as it is passed through for extracting fluid from said absorbing member.

25. The container according to claim 24, wherein said extracting element is shaped as an “

o-ring”

circumferentially mounted on the walls of the container.

26. The container according to claim 24, wherein a plurality of extracting elements are arranged within said sample container so that they form a passage which gradually decreases in diameter, for applying increased pressure onto the walls of said absorbing member as it is passed through.

27. The container according to claim 24, wherein said extracting element is a curve of a wall of said container, forming an internally facing bulge within the container.

28. (canceled)