Diagnostic Test Devices

• US 20070244368A1
• Filed: 02/23/2005
• Published: 10/18/2007
• Est. Priority Date: 02/23/2004
• Status: Active Grant

• Current Assignee: Woundcheck Laboratories (US), Inc., Woundchek Laboratories (US), Inc.
• Original Assignee: Systagenix Wound Management Ip Co., B.V (3M Company), Systagenix Wound Management (US), Inc.
• Inventors: Del Bono, Michelle, Lindsay-Watt, Sylvia, Bayloff, Simon, Biott, Maurice
• Granted Patent: US 7,601,546 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• 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 10/0266 means for severing sample
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2010/0006 involving a colour change
• 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 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• 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: Y10T 436/25 including sample preparation

Abstract

A diagnostic test apparatus comprising: a shaft having a first end and a second end; a swab or a biopsy punch mounted on the first end of a shaft; and a cap for fitting over the first end of the shaft, said cap containing at least one diagnostic test reagent; wherein the shaft comprises at least one cap engagement element located proximate to the first end, said element extending radially outwardly of the swab or the biopsy punch for engagement with the cap to retain the cap on the shaft. Also provided are diagnostic caps for use in the test apparatus having a small internal volume and at least one diagnostic test reagent located in or on an absorbent plug inside the cap. Also provided are diagnostic caps for use in the test apparatus having a housing extending from a sample receiving port, said housing defining a lateral flow path for the sample. Also provided is a test system comprising a swab shaft, a biopsy punch shaft and a diagnostic cap in accordance with the invention, wherein the cap can be used interchangeably between the two different shafts.

Claims

1. A diagnostic test apparatus comprising:

a shaft having a first end and a second end;

a swab or a biopsy punch mounted on the first end of a shaft; and

a cap for fitting over the first end of the shaft, said cap containing at least one diagnostic test reagent;

wherein the shaft comprises at least one cap engagement element located proximate to the first end, said element extending radially outwardly of the swab or the biopsy punch for engagement with the cap to retain the cap on the shaft.

2. A diagnostic test apparatus according to any preceding claim, wherein the cap engagement element is selected from the group consisting of:

a tapered region of the shaft for forming an interference fit with the cap, a snap-fitting projection for forming a snap-fit with one or more complementary projections on an inner surface of the cap, and a thread projection for forming a screw fit with one or more complementary threads on an inner surface of the cap.

3. A diagnostic test apparatus according to any preceding claim, wherein the shaft is hollow, whereby a fluid can be passed down the shaft to expel a biological sample from the swab or the biopsy punch.

4. A diagnostic test apparatus according to any preceding claim, wherein the complementary fitting elements on the cap and the shaft are adapted to provide a substantially liquid-tight seal between the cap and the shaft.

5. A diagnostic test apparatus according to any preceding claim, wherein, when the cap is secured on the shaft, the swab or the biopsy is in contact with an absorbent material that can wick fluid from the swab or the biopsy to the one or more diagnostic reagents.

6. A diagnostic test apparatus according to any preceding claim, wherein a swab is attached to the first end of the shaft and the sample receiving port of the cap is dimensioned such that, when the cap is secured on the shaft, the swab is compressed by the diagnostic cap to squeeze fluid out of the swab.

7. A diagnostic test apparatus according to any preceding claim, wherein a biopsy punch is attached to the first end of the shaft and the cap further comprises an internal projection adapted to crush or macerate a tissue sample in the biopsy punch when the punch is secured on the cap.

8. A diagnostic test apparatus according to any preceding claim, wherein the cap is at least partially transparent, or the cap comprises one or more window openings therein, to permit visual observation of a diagnostic indicator inside the cap.

9. A diagnostic cap for use in an apparatus according to any of claims 1 to 8, comprising a substantially cup-shaped body, an absorbent plug located within the body, and at least one diagnostic test reagent located in or around the absorbent plug.

10. A diagnostic cap according to claim 9, wherein the at least one diagnostic test reagent is provided in or on an annular diagnostic strip extending radially around the inside of the cap.

11. A diagnostic cap according to claim 9, wherein at least one diagnostic test reagent is provided in or on a diagnostic sheet extending transversely across the inside of the cap.

12. A diagnostic cap according to claim 9, wherein the absorbent plug has an uncompressed volume of from about 10 to about 1000 mm³, preferably from about 50 to about 300 mm³.

13. A diagnostic cap for use in a diagnostic apparatus according to any of claims 1 to 8, wherein the cap comprises a sample receiving port having an interior surface configured for engagement with the cap engagement elements on the shaft, and a housing defining a lateral flow path for a liquid sample, the lateral flow path having an inlet end in fluid communication with the sample receiving port

14. A diagnostic cap according to claim 13, wherein the housing further comprises a base for the cap, whereby the cap can rest on said base on a horizontal surface with the sample receiving port opening in an upward direction to receive the shaft.

15. A diagnostic cap according to claim 14, wherein the housing has a substantially flat lower surface forming said base for the housing, and the sample receiving port opens upwardly from an upper surface of the housing opposite said flat lower surface.

16. A diagnostic cap according to claim 14 or 15, wherein the lateral flow path extends substantially in a plane that is substantially perpendicular to the axis of the sample receiving port.

17. A diagnostic cap according to any of claims 14 to 16, wherein the housing contains a plurality of lateral flow paths for detecting a plurality of different analytes.

18. A diagnostic cap according to claim 17, wherein the plurality of lateral flow paths are spaced radially around the sample receiving port, preferably in a plane substantially perpendicular to the axis of the sample receiving port.

19. A diagnostic test system comprising a first diagnostic test apparatus according to any of claims 1 to 8, wherein the shaft has a swab attached thereto, and a second diagnostic test apparatus according to any of claims 1 to 8, wherein the shaft has a biopsy punch attached thereto, and wherein the diagnostic caps can be secured interchangeably on the shafts of the first and second apparatuses.