Self contained diagnostic test unit

• US 5,869,003 A
• Filed: 04/15/1998
• Issued: 02/09/1999
• Est. Priority Date: 04/15/1998
• Status: Expired due to Fees

• Current Assignee: Frederic L. Nason
• Original Assignee: Frederic L. Nason
• Inventors: Nason, Frederic L.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/060,840
• Time in Patent Office: 300 Days
• Field of Search: 422/56, 422/58, 422/61, 422/99-102, 422/104
• US Class Current: 422/411
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/02 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: B01L 2400/0644 rotary valves
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• 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

Abstract

A self contained diagnostic test unit is provided for use in the collection and analysis of a biological specimen or the like. The test unit comprises a tubular housing defining a specimen chamber for receiving a specimen disposed, for example, on a specimen collection device such as a swab or the like. A reagent dispenser cap may be associated with the housing for delivering one or more selected reagents to the specimen chamber for contacting the collected specimen. A diagnostic strip assembly is mounted on the housing and comprises a diagnostic test strip adapted for controlled contact with the collected specimen, for causing a portion of the specimen to flow by wick action through the test strip. The specimen interacts with one or more reagents disposed along the test strip to produce a visible reaction such as a color change which can be observed from the exterior of the test unit to provide an indication of the result of a selected diagnostic test.

Claims

1. A diagnostic test unit, comprising:

an elongated hollow housing having a proximal end and a distal end, said housing defining a specimen chamber for receiving therein a specimen for analysis;

a cap removably mounted on said proximal end of said housing; and

a diagnostic strip assembly mounted on said distal end of said housing, said diagnostic strip assembly including a diagnostic strip of a porous material for fluid flow along said strip by wick action, means for supporting said diagnostic strip to extend generally along the exterior of said specimen chamber, and transfer means for controllably coupling a specimen within said specimen chamber for flow to and contact with one end of said diagnostic strip, whereby the specimen will flow along said strip by wick action;

said strip carrying at least one reagent for contact by the specimen flowing along said strip to provide a visual indication of test result.

2. The diagnostic test unit of claim 1 wherein said housing comprises a tubular housing.

3. The diagnostic test unit of claim 1 further including means for collecting a specimen, said collecting means having a size and shape to fit into said specimen chamber.

4. The diagnostic test unit of claim 3 wherein said collecting means comprises a swab.

5. The diagnostic test unit of claim 4 wherein said diagnostic strip assembly comprises a generally cylindrical fitment positioned within said housing at the distal end thereof, and an outlet port for outflow of the specimen from said specimen chamber to said strip, said fitment defining a well for relatively close fit reception of a tip of said swab.

8. The diagnostic test unit of claim 1 wherein said transfer means comprises valve means for normally closing an outlet port disposed between said specimen chamber and said one end of said strip, said valve means being movable from a normally closed position to an open position permitting the specimen to flow from said specimen chamber to said one end of said strip.

9. The diagnostic test unit of claim 8 wherein said valve means comprises a valve plug rotatably between said closed and open positions.

10. The diagnostic test unit of claim 8 further including a transfer wick extending from said outlet port to said one end of said strip.

11. The diagnostic test unit of claim 10 wherein said transfer wick comprises a porous compressible element retained under compression between said outlet port and said strip, a portion of said compressible element being adapted for expansion through said outlet port to extend partially into said specimen chamber upon movement of said valve means to said open position.

12. The diagnostic test unit of claim 10 wherein said transfer wick is impregnated with at least one additional reagent.

13. The diagnostic test unit of claim 10 wherein said transfer wick includes an upstream end for alignment with said outlet port, and a downstream end defined by multiple fingers each carrying a different reagent and adapted for respective contact with said one end of said strip in response to stepwise movement of said valve means.

14. The diagnostic test unit of claim 1 wherein said transfer means comprises a transfer wick interposed between said specimen chamber and said one end of said strip.

15. The diagnostic test unit of claim 14 wherein said transfer wick includes a time delay coating adapted for controlled dissolution upon contact with mixed specimen and reagent within said specimen chamber.

16. The diagnostic test unit of claim 1 wherein said cap comprises a reagent dispenser cap including means for delivering at least one reagent into said specimen chamber for contacting a specimen therein.

17. The diagnostic test unit of claim 1 wherein said diagnostic stip assembly includes a plurality of diagnostic strips, said transfer means controllably coupling a specimen within said specimen chamber for flow to and contact with one end of each of said strips.

6. The diagnostic test unit of 1 wherein said means for supporting said diagnostic strip comprises a protective outer sleeve mounted about said housing and having said strip supported therein between said housing and said sleeve, said sleeve including a transparent window to permit visual observation of said strip.

7. The diagnostic test unit of claim 6 wherein said window comprises a magnification window.

18. A diagnostic test unit, comprising:

an elongated hollow housing having a proximal end and a distal end, said housing defining a specimen chamber for receiving therein a specimen for analysis;

a reagent dispenser cap removably mounted on said proximal end of said housing, said reagent dispenser cap including means for delivering at least one reagent into said specimen chamber for contacting a specimen therein; and

a diagnostic strip assembly mounted on said distal end of said housing, said diagnostic strip assembly comprising a diagnostic strip or a porous material for fluid flow along said strip by wick action, a strip holder having a channel therein for receiving and supporting said strip, mounting means for supporting said strip holder on the exterior of said housing generally at the distal end of said housing, a protective outer sleeve mounted about said strip holder and said strip generally at the distal end of said housing, said sleeve having a transparent window to permit visual observation of said strip, and transfer means between said distal end of said housing and one end of said strip for controllably coupling mixed specimen and reagent within said specimen chamber for flow to and contact with one end of said strip, whereby mixed specimen and reagent will flow along said strip by wick action;

said strip carrying at least one reagent for contact by mixed specimen and reagent flowing along said strip to provide a visual indication of test result.

19. The diagnostic test unit of claim 18 wherein said housing comprises a tubular housing.

20. The diagnostic test unit of claim 18 further including means for collecting a specimen, said collecting means having a size and shape to fit into said specimen chamber.

21. The diagnostic test unit of claim 20 wherein said collecting means comprises a swab.

22. The diagnostic test unit of claim 21 wherein said diagnostic strip assembly comprises a generally cylindrical fitment positioned within said housing at the distal end thereof, and an outlet port for outflow of mixed specimen and reagent from said specimen chamber to said strip, said fitment defining a well for relatively close fit reception of a tip of said swab.

23. The diagnostic test unit of claim 18 wherein said transfer means comprises valve means for normally closing an outlet port disposed between said specimen chamber and said one end of said strip, said valve means being movable from a normally closed position to an open position permitting mixed specimen and reagent to flow from said specimen chamber to said one end of said strip.

24. The diagnostic test unit of claim 23 wherein said valve means comprises a valve plug rotatably carried by said sleeve.

25. The diagnostic test unit of claim 23 further including a transfer wick extending from said outlet port to said one end of said strip.

26. The diagnostic test unit of claim 25 wherein said transfer wick comprises a porous compressible element retained under compression between said outlet port and said strip, a portion of said compressible element being adapted for expansion through said outlet port to extend partially into said specimen chamber upon movement of said valve means to said open position.

27. The diagnostic test unit of claim 25 wherein said transfer wick is impregnated with at least one additional reagent.

28. The diagnostic test unit of claim 18 wherein said transfer means comprises a transfer wick interposed between said specimen chamber and said one end of said strip.

29. The diagnostic test unit of claim 28 wherein said transfer wick includes a time delay coating adapted for controlled dissolution upon contact with mixed specimen and reagent within said specimen chamber.

30. The diagnostic test unit of claim 18 wherein said window comprises a magnification window.