DIAGNOSTIC TEST DEVICE AND METHOD OF USING SAME

• US 20050084842A1
• Filed: 10/20/2003
• Published: 04/21/2005
• Est. Priority Date: 10/20/2003
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: O'Connor, Amanda Lee
• Granted Patent: US 6,991,898 B2
• Time in Patent Office: Days
• US Class Current: 435/4
• 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 2010/0006 involving a colour change
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 1/02 Devices for withdrawing samples sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising
• CPC Class Codes: G01N 2015/0088 Biological contaminants; Fouling
• CPC Class Codes: G01N 2015/019 Biological contaminants; Fouling
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

A self contained diagnostic test device is provided for use in the collection and detection of a biological specimen or the like. The device comprises a tubular swab and reagent dispensing cap component for receiving specimens. The reagent dispensing cap component includes barrel, reagent chamber, and results window subcomponents, and delivers one or more selected reagents to a specimen testing chamber for contacting the collected specimen, upon the rotation of the reagent chamber component.

Claims

1. A diagnostic test device for detecting the presence of microorganisms comprising:

a cap component comprising

at least one barrel component for receiving a swab, said at least one barrel component including an inside surface and an outside surface, and defining an interior barrel space,

a results window component for viewing test results from a test strip, said results windows component including at least one viewing window,

a reagent chamber component between said at least one barrel component and said results window component;

said reagent chamber component defining an interior reagent chamber space in spatial communication with said at least one barrel component and said results window component and including at least one reagent chamber for containing at least one reagent or test solution, said reagent chamber component being rotatably connected to said results window component and rotatable with respect to a core contained in said reagent chamber space,

said core including a test strip; and

a swab component for removable insertion through said barrel component to said reagent chamber component;

whereby said reagent chamber component can be rotated from a pre-use position to a use position, such that when rotated said at least one reagent chamber moves from a closed position to an open position, thereby delivering reagent contained in said at least one reagent chamber onto said test strip.

2. The diagnostic test device of claim 1 wherein said barrel component includes a first interlocking mechanism on said inside surface, and said swab component includes a second interlocking mechanism, such that said first and said second interlocking mechanisms releasably lock with each other, upon insertion of said swab component in said barrel component.

3. The diagnostic test device of claim 2 wherein said interlocking mechanisms are selected from the group consisting of screw mechanisms, interlocking flange mechanisms, and tab and slot mechanisms.

4. The diagnostic test device of claim 1 wherein said barrel component includes an elevated collar structure on said inside surface for directing said swab component to said reagent chamber component.

5. The diagnostic test device of claim 1 wherein said results window component includes at least two viewing windows.

6. The diagnostic test device of claim 5 wherein one of said at least two viewing windows is a control viewing window.

7. The diagnostic test device of claim 1 wherein said results window component defines a results window interior space having an angled interior wall angled upward toward said results window.

8. The diagnostic test device of claim 1 wherein said reagent chamber component includes at least two reagent chambers.

9. The diagnostic test device of claim 1 wherein said core includes structural extensions for directing a reagent to said test strip.

10. The diagnostic test device of claim 1, wherein said barrel component includes at least one flat side, said results window component includes at least one flat side in alignment with said barrel component flat side, and said reagent chamber component includes at least one flat side, whereby as said reagent chamber component is rotated with respect to said results window component, said reagent chamber component flat side becomes aligned with said barrel and results window components flat sides, as said reagent chamber component moves from a closed to an open position.

11. The diagnostic test device of claim 1, wherein said barrel component includes at least one marking, said results window component includes at least one marking in alignment with said barrel component marking, and said reagent chamber component includes at least one marking, whereby as said reagent chamber component is rotated with respect to said results window component, said reagent chamber component marking becomes aligned with said barrel and results window component markings, as said reagent chamber moves from a closed to an open position.

12. The diagnostic test device of claim 11, wherein said markings are selected from lines, patterns, symbols, flat and textured surfaces.

13. The diagnostic test device of claim 1, wherein said test strip is an elongated test strip which extends from said reagent chamber component to said results window component.

14. The diagnostic test device of claim 1, wherein said core is U-shaped.

15. The diagnostic test device of claim 1, wherein said core is circular.

16. The diagnostic test device of claim 1, wherein said swab component includes a handle portion and said handle portion is of such a length that it always protrudes from said barrel component upon insertion into said barrel component.

17. The diagnostic test device of claim 1, wherein said diagnostic test device is generally tubular in configuration.

18. The diagnostic test device of claim 15, wherein said U-shaped core defines an interior core space, and said U-shaped core includes an opening into said core space defined by an inner arc in degrees, and further wherein said reagent chambers are defined by an outer arc in degrees, wherein said inner arc is greater in size than said outer arc.

19. The diagnostic test device of claim 1, wherein said reagent chamber component includes side walls, said core has an outer wall, and at least one reagent chamber is formed from said side walls and said outer wall.

20. The diagnostic test device of claim 1, wherein said reagent chamber component includes side walls of a certain height, said barrel component and said results window component include walls of a height greater than or equal to said reagent chamber side walls, and at least one reagent chamber is formed from said reagent chamber component side walls and said barrel and results window component walls.

21. The diagnostic test device of claim 1, wherein said core is integrally connected to said results window component.

22. The diagnostic test device of claim 1, wherein said core is integrally connected to said barrel component.

23. The diagnostic test device of claim 1 wherein said reagent chamber component is integrally connected to said barrel component and is rotatable with said barrel component.

24. A method for detecting the presence of microorganisms comprising the steps of:

a) providing a diagnostic test device comprising;

a cap component comprising

at least one barrel component for receiving a swab, said at least one barrel component including an inside surface and an outside surface, and defining an interior barrel space,

a results window component for viewing test results from a test strip, said results windows component including at least one viewing window,

a reagent chamber component between said at least one barrel component and said results window component;

said reagent chamber component defining an interior reagent chamber space in spatial communication with said at least one barrel component and said results window component and including at least one reagent chamber for containing at least one reagent or test solution, said reagent chamber component being rotatably connected to said results window component such that when rotated, said reagent chamber within said reagent chamber component moves from a closed position to an open position,

a core situated within said reagent chamber space, said core being independent from said reagent chamber component and including a test strip; and

a swab component for removable insertion through said barrel component to said reagent chamber component,

b) swabbing said swab component onto a selected body cavity or environmental location,

c) inserting said swab component through said barrel component and into said reagent component, thereby placing the swab on said swab component adjacent said test strip;

d) rotating said reagent chamber component such that said reagent chamber moves from a closed to an open position, thereby delivering said reagent onto said swab and said test strip,

e) viewing said test strip through said window.

25. A diagnostic test device for detecting the presence of microorganisms comprising:

a cap component comprising

at least one barrel component for receiving a swab, said at least one barrel component including an inside surface and an outside surface, and defining an interior barrel space,

a results window component for viewing test results from a test strip, said results windows component including at least one viewing window,

a reagent chamber component between said at least one barrel component and said results window component;

said reagent chamber component defining an interior reagent chamber space in spatial communication with said at least one barrel component and said results window component and including at least one reagent chamber for containing at least one reagent or test solution, said reagent chamber component being rotatably connected to said results window component and rotatable with respect to a core contained in said reagent chamber space, said core including a test strip,

whereby said reagent chamber component can be rotated from a pre-use position to a use position, such that when rotated, said at least one reagent chamber moves from a closed position to an open position, thereby delivering reagent contained in said at least one reagent chamber onto said test strip.