Specimen test unit

• US 5,238,649 A
• Filed: 11/25/1991
• Issued: 08/24/1993
• Est. Priority Date: 02/09/1988
• Status: Expired due to Term

• Current Assignee: Frederic L. Nason
• Original Assignee: Frederic L. Nason
• Inventors: Nason, Frederic L.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Collins, Laura E.
• Application Number:
  US07/796,661
• Time in Patent Office: 638 Days
• Field of Search: 422/56, 422/57, 422/58, 422/61, 422/100, 422/101, 422/102, 422/294, 435/295, 435/296, 435/810, 128/759, 128/771, 604/1, 604/2, 604/3
• US Class Current: 422/411
• 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 2010/0216 Sampling brushes
• CPC Class Codes: A61F 13/38 Swabs having a stick-type handle, e.g. cotton tips ear cleaners other than cotton tips A61F11/006; swabs containing a liquid, e.g. in a rupturable reservoir, A61M35/006
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/0272 Dropper bottles
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising

Abstract

An improved test unit is provided for use in the collection and analysis of biological specimens and the like. The specimen test unit includes a swab member adapted for collection of a specimen to be tested. The test unit incorporates one or more reagents or other test fluids for delivery into contact with the specimen on the swab member. In accordance with various embodiments, the contacted specimen and fluid are then delivered through one or more porous members for analysis and/or to contact an additional reagent or reagents in the course of performing a selected test. In some forms, one or more of the porous members is preimpregnated with a selected reagent or constituent thereof. Moreover, in some forms, one or more of the porous members is formed from a hydrophobic material to serve as a fluid seal until fluid is forced therethrough, for example, by squeezing a reagent-containing housing member of the test unit. In all embodiments, the test unit is substantially self-contained to perform the desired test, with minimal risk of exposing testing personnel to the collected specimen and/or to the various reagents.

Claims

1. A specimen test unit for use in collection and analysis of a biological specimen, said test unit comprising:

an elongated, generally hollow housing member having open opposite ends;

an occluding member having at least one flow orifice formed therein and disposed generally at a first end of said housing member;

a specimen collector having means for collecting a specimen and having a size and shape for collecting a specimen and having a size and shape for placement with the specimen into said housing member via a second end of said housing member, said housing member being adapted to receive at least one reagent;

a base member for mounting onto said second end of said housing member subsequent to placement of said specimen collector with the specimen into said housing member, said base member cooperating with said housing member and said occluding member to define a substantially closed specimen chamber having said specimen collector and specimen and reagent therein;

said flow orifice of said occluding member having a sufficiently small size for preventing unforced flow of the specimen and reagent within said specimen chamber, said flow orifice permitting pressure forced flow of the specimen and reagent from said specimen chamber to an exterior of said housing member; and

vacuum drawing means operatively and removably connected to said flow orifice for vacuum drawing a portion of the specimen and reagent from said specimen chamber through said flow orifice to the exterior of said housing member.

2. The specimen test unit of claim 1 further including a cap mounted removably over said occluding member to close said flow orifice.

3. The specimen test unit of claim 1 wherein said housing member is formed at least in part from a resilient material to permit manual squeezing thereof to increase the relative pressure within said specimen chamber and thereby pressure force a portion of the specimen and reagent within said specimen chamber to flow through said flow orifice.

4. The specimen test unit of claim 1 wherein said base member has an elongated hollow construction with an open end and a closed end, said base member open end being slidably and telescopically engageable with said second end of said housing member for mounting said base member onto said housing member.

5. The specimen test unit of claim 4 wherein at least one of said housing member and said base member has at least a portion thereof formed from a resilient material to permit manual squeezing thereof to increase relative pressure within said specimen chamber and thereby pressure force a portion of the specimen and reagent within said specimen chamber to flow through said flow orifice.

6. The specimen test unit of claim 1 wherein said specimen collector comprises a swab member.

7. The specimen test unit of claim 6 wherein said swab member is mounted on said base member for placement into said housing member when said base member is mounted onto said housing member second end.

8. The specimen test unit of claim 1 wherein said base member is removably mounted onto said housing member.

9. The specimen test unit of claim 4 wherein said base member includes means for carrying the reagent and for delivering the reagent to said specimen chamber when said base member is mounted onto said housing member second end.

10. The specimen test unit of claim 1 wherein said vacuum drawing means comprises a vacuum housing mounted over and covering said flow orifice in said occluding member, said vacuum housing being manually deformable to vacuum draw a portion of the specimen and reagent through said flow orifice into said vacuum housing.

11. The specimen test unit of claim 10 wherein said vacuum housing is removably mounted onto said housing member.

12. The specimen test unit of claim 10 wherein said vacuum housing includes at least one resilient wall portion to permit manual squeezing and release, thereby vacuum drawing the specimen and reagent through said flow orifice.

13. The specimen test unit of claim 10 wherein said vacuum housing has an elongated hollow shape with one open and one closed end, said open end being slidably and telescopically engageable with said first end of said housing member.

14. The specimen test unit of claim 10 further including a wick element within said vacuum housing.

15. The specimen test unit of claim 14 further including means for delivering the portion of the specimen and reagent drawn through said flow orifice to a selected end of said wick element.

16. The specimen test unit of claim 1 wherein said vacuum drawing means comprises a first vacuum housing mounted over and covering said flow orifice in said occluding member, said first vacuum housing being manually deformable to vacuum draw a portion of the specimen and reagent through said flow orifice and into said first vacuum housing, and a second vacuum housing mounted onto said first vacuum housing and being manually deformable to vacuum draw a portion of the specimen and reagent from said first vacuum housing into said second vacuum housing.

17. A specimen test unit for use in collection and analysis of a biological specimen, said test unit comprising:

an elongated, generally hollow housing member having open opposite ends;

an occluding member having at least one flow orifice formed therein and disposed generally at a first end of said housing member;

a specimen collector having means for collecting a specimen and having a size and shape for placement with the specimen into said housing member via a second end of said housing member, said housing member being adapted to receive at least one reagent;

a base member for mounting onto said second end of said housing member subsequent to placement of said specimen collector with the specimen into said housing member, said base member cooperating with said housing member and said occluding member to define a substantially closed specimen chamber having said specimen specimen collector, specimen, and reagent therein;

said flow orifice of said occluding member having a sufficiently small size for preventing unforced flow of the specimen and reagent within said specimen chamber, said flow orifice permitting pressure forced flow of the specimen and reagent from said specimen chamber to the exterior of said housing member; and

a secondary housing member mounted over and covering said flow orifice in said occluding member, said secondary housing member receiving the specimen and reagent upon flow thereof from said specimen chamber through said flow orifice; and

a wick element within said secondary housing.

18. The specimen test unit of claim 17 further including means for delivering the specimen and reagent from said flow orifice to a selected end of said wick element, said means for delivering being located within said secondary housing member.

19. A specimen test unit for use in collection and analysis of a biological specimen, said test unit comprising:

an elongated, generally hollow housing member having open opposite ends;

an occluding member having at least one flow orifice formed therein and disposed generally at a first end of said housing member;

a specimen collector having means for collecting a specimen and having a size and shape for placement with the specimen into said housing member via a second end of said housing member, said housing member being adapted to receive at least one reagent;

a base member for mounting onto said second end of said housing member subsequent to placement of said specimen collector with the specimen into said housing member, said base member cooperating with said housing member and said occluding member to define a substantially closed specimen chamber having said specimen collector, and specimen, and reagent therein;

said flow orifice of said occluding member having a sufficiently small size for preventing unforced flow of the specimen and reagent within said specimen chamber, said flow orifice permitting pressure forced flow of the specimen and reagent from said specimen chamber to an exterior of said housing member; and

a wick element having one end mounted within said flow orifice and projecting outwardly therefrom said wick element being positioned to contact the specimen and reagent within said specimen chamber for capillary flow thereof through said flow orifice to the exterior of said housing member.

20. The specimen test unit of claim 19 wherein said wick element has a reagent disposed at a determined position along the length thereof.

21. A specimen test unit for use in collection and analysis of a biological specimen, said test unit comprising:

an elongated, generally hollow housing member having open opposite ends;

an occluding member having at least one flow orifice formed therein and disposed generally at a first end of said housing member;

a specimen collector having means for collecting a specimen and having a size and shape for placement with the specimen into said housing member via a second end of said housing member, said housing member being adapted to receive at least one reagent;

a base member for mounting onto said second end of said housing member subsequent to placement of said specimen collector with the specimen into said housing member, said base member cooperating with said housing member and said occluding member to define a substantially closed specimen chamber having said specimen collector, and specimen, and reagent therein;

said flow orifice of said occluding member having a sufficiently small size for preventing unforced flow of the specimen and reagent within said specimen chamber, said flow orifice permitting pressure forced flow of the specimen and reagent from said specimen chamber to an exterior of said housing member; and

said housing member further including means defining a mixing chamber, said flow orifice defining a first port leading from said mixing chamber to the exterior of said housing member, and further including means defining a second port communicating between said specimen and mixing chambers.

22. The specimen test unit of claim 21 wherein said housing member is deformable to permit manual compression of said specimen and mixing chambers, whereby the specimen and reagent are transferrable back and forth through said second port between the specimen and mixing chambers upon deformation of said housing member to alternately compress said specimen and mixing chambers.

23. The specimen test unit of claim 22 wherein said housing member is deformable at a position between said specimen and mixing chambers to occlude said second port whereby said housing member is further deformable to compress said mixing chamber to dispense specimen and reagent therein through said first port.

24. The specimen test unit of claim 23 wherein said housing member includes a web having said second port formed therein and extending between said specimen and mixing chambers.