Assay device for swab borne analytes

• US 5,084,245 A
• Filed: 12/20/1990
• Issued: 01/28/1992
• Est. Priority Date: 11/07/1988
• Status: Expired due to Fees

• Current Assignee: Hygeia Sciences, Inc. (The Procter & Gamble Company)
• Original Assignee: Hygeia Sciences, Inc. (The Procter & Gamble Company)
• Inventors: Lennon, Donald J., Foster, Paul B., Berke, Carl M., Boys, Gary W.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Singla, Abanti B.
• Application Number:
  US07/630,432
• Time in Patent Office: 404 Days
• Field of Search: 422/61, 422/101, 422/102, 435/810, 435/295, 435/211, 436/808, 436/810
• US Class Current: 422/411
• 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: C12M 33/02 by impregnation, e.g. using swabs or loops fluid transport using swabs B01L3/5029
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A disposable, pre-packaged device as particularly suitable for conducting diagnostic procedures based on immunological reactions using specimens gathered up in the absorbent tip of a swab. The device is made up of a base component upon which a sample sensitive element is mounted and a guide member that is normally mounted on the base component in covering relationship to the reactive element. The guide member includes structure which defines an elongated passageway extending therethrough. One end of the passageway is positioned in close proximity to the sensitive element when the member is mounted on the base component. The other end of the passageway opens outwardly of the guide member. In using the device, the swab tip is pushed through the passageway and toward the sensitive element using the stick of the swab. A number of ribs are positioned in the passageway adjacent the sensitive element to squeeze the tip and express fluid therefrom as the tip is pushed toward the sensitive element. Thus, the liquid in the swab tip is expressed therefrom and brought into intimate contact with the sensitive element. The results of the test are visually observable by removing the guide member from the base component to uncover the sensitive element.

Claims

1. A disposable kit for conducting an assay test, said kit comprising:

a swab comprising an elongated stick and an absorbent tip at one end of the stick for carrying a fluid material containing an analyte or derivative thereof;

a base component;

a contact element mounted on the base component, said element being sensitive to the presence of an analyte or derivative thereof which comes into contact therewith;

a guide member for mounting on the base component over the contact element, said member being removable from the base component so as to permit inspection of the contact element,

said guide member having an elongated passageway extending therethorugh, said passageway having a first open end that is positioned adjacent the contact element when the member is mounted on the base component, said passageway having a second open end that is spaced from said first open end, said second open end constructed so as to open outwardly of the kit when the member is mounted on the base component,

said passageway including funnel means at said second open end thereof so as to receive the tip of said swab said funnel means further being constructed so as to guide said tip into the passageway as the stick is manually pushed through the passageway and toward said first end thereof; and

squeeze structure located in the passageway adjacent said first end so as to contact the swab tip when said manually pushed swab stick and said tip are being pushed through the passageway and toward the contact element, so as to cause the tip to be squeezed such that fluid material is expressed therefrom.

2. A kit as set forth in claim 1, wherein said passageway is generally circular in cross-sectional configuration and said squeeze structure comprises projection means which protrude in a radially inward direction into the passageway so as to restrict the cross-sectional area of the passageway.

3. A kit as set forth in claim 2, wherein said projection means comprises a plurality of ribs spaced circumferentially around the passageway, each rib extending along the passageway.

4. A kit as set forth in claim 3, wherein said ribs are uniformly distributed around the circumference of the passageway and wherein each rib has a length which is approximately 11/2 of the overall length of the swab tip.

5. A kit as set forth in claim 3, wherein said ribs are constructed and arranged so as to define channels therebetween extending along the passageway to facilitate flow of expressed fluid toward the contact element.

6. A kit as set forth in claim 1, wherein said funnel means comprises means defining a generally conically shaped tip receiving chamber having an outer opening which is larger in diameter than the swab and a smaller inner opening.

7. A kit as set forth in claim 1, further including a prefilter carried by said guide member in a position so as to cover said first open end of the passageway.

8. A kit as set forth in claim 1, wherein said base component and said guide member include releasable means for holding the base component and guide member together during testing and permitting separation of the same at the completion of a test.

9. A kit as set forth in claim 8, wherein said releasable means defines a well in the base component and a complimentarily shaped projecting portion on the guide member, said projecting portion being received in the well and held in place by frictional engagement.

10. A kit as set forth in claim 9, wherein the well is further defined by a sidewall and a floor, and the complimentarily shaped projecting portion has an external surface and a distal end, said contact element being mounted on the floor of the well and said first open end of the passageway being disposed at said distal end of said portion, said frictional engagement being between said sidewall and said external surface.

11. A kit as set forth in claim 10, wherein said well is generally circular and said surface is cylindrical.

12. A kit as set forth in claim 10, further including vent means for venting air from the well.

13. A kit as set forth in claim 12, wherein said vent means comprises a groove extending from the floor and along the sidewall of the well.

27. A kit as set forth in claim 1, wherein said base component and said guide member are each molded from a thermoplastic material.

31. A kit as set forth in claim 8, wherein said releasable means comprises a well in the base component and a flange portion on the guide member, said flange portion being received in the well, said well further comprising an inwardly extending lip disposed around the well, said lip and said flange portion cooperating when the flange portion is in the well so as to releasably hold the guide member in place during operation of the device and permit removal of the guide member such that the contact element may be inspected.

32. A kit as set forth in claim 31, wherein said flange portion is circular and said lip is annular.

14. A disposable kit for conducting an immunoassay, said kit comprising:

a swab comprising an elongated stick and an absorbent tip at one end of the stick for carrying a fluid material containing an immunoreactive constituent;

a base component having an upper surface and including an internal sidewall and a floor defining a test well that opens upwardly of said upper surface;

a contact element disposed on said floor, said element being sensitive to the presence of an immunoreactive constituent with which said element comes into contact therewith;

a guide member including a projecting portion having an outer surface, said guide member being shaped so as to communicate with the internal sidewall of the base, said portion being positioned within said well with its outer surface engaging the internal sidewall of the base, and being removable from the base for visual inspection of the contact element,

said guide member having an elongated passageway extending through said portion, said passageway having a first open end that is positioned adjacent the contact element so as to open toward the contact element when said portion is positioned in the well, said passageway having a second open end that is spaced from said first end so as to open upwardly of the device when said portion is positioned in the well,

said passageway including funnel means located at said second open end thereof so as to receive the tip of said swab, said passageway further being constructed so as to guide said tip into and through the passageway and toward said first open end thereof by manually pushing said stick of said swab,

said passageway comprising means for directing the swab tip of said manually pushed stick toward the contact element; and

squeeze structure located in the passageway adjacent said first open end thereof so as to contact said swab tip of said manually pushed stick, said squeeze structure being constructed so as to squeeze said tip to express fluid material therefrom.

15. A kit as set forth in claim 14, further including a prefilter attached to the projecting portion in a position so as to cover said first open end of the passageway.

16. A kit as set forth in claim 14, wherein the internal sidewall of said well is circular and the external surface of said projecting portion is cylindrical in shape.

17. A kit as set forth in claim 14, wherein said base component and said guide member are each molded from thermoplastic material.

18. A kit as set forth in claim 17, wherein the sidewall of said well and the external surface of said projecting portion are each cylindrical in shape.

19. A kit as set forth in claim 18, wherein the external surface of the projecting portion and the sidewall of the well cooperate to provide a frictional fit so as to hold the projecting portion in the well.

20. A kit as set forth in claim 14, wherein the external surface of the projecting portion and the sidewall of the well cooperate to provide a frictional fit so as to hold the projecting portion in the well during the conduct of test procedures.

21. A kit as set forth in claim 14, further including means on the external surface of the projecting portion and on the internal sidewall of the well for venting the well.

22. A kit as set forth in claim 14, wherein said passageway is generally circular in cross-sectional configuration and said squeeze structure comprises projection means which protrude in a radially inwardly direction into the passageway so as to restrict the cross-sectional area of the passageway.

23. A kit as set forth in claim 22, wherein said projection means comprises a plurality of ribs spaced circumferentially around the passageway, each rib extending along the passageway.

24. A kit as set forth in claim 23, wherein said ribs are uniformly distributed around the circumference of the passageway and each rib has a length which is approximately 1/2 of the overall length of the swab tip.

25. A kit as set forth in claim 23, wherein said ribs present channels therebetween extending along the passageway to facilitate flow of expressed fluid toward the contact element.

26. A kit as set forth in claim 24, wherein said funnel means comprises means defining a generally conical shaped tip receiving chamber having an outer opening which is larger in diameter than the swab tip and a smaller inner opening.

28. A kit as set forth in claim 14, wherein said element comprises a porous capture membrane.

29. A kit as set forth in claim 28, wherein an immunoreactive component is attached to said membrane.

30. A kit as set forth in claim 28, wherein the pores of said membrane are of a size to prevent passage of an immunocomposite created.

33. A kit as set forth in claim 17, wherein said guide member is cylindrical in shape.

34. A kit as set forth in claim 17, wherein said guide member is generally spool shaped.