Device

• US 20130065245A1
• Filed: 08/29/2012
• Published: 03/14/2013
• Est. Priority Date: 12/19/2006
• Status: Abandoned Application

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Rutter, Paul, Jones, Chris, Ledgeway, Andrew, Gani, James, Tissington, Bryan
• Application Number:
  US13/598,019
• Publication Number:
  US 20130065245A1
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs

Abstract

Provided is an assay device and kit for detecting the presence or amount of an analyte of interest.

Claims

1. An assay device for determining the presence and/or amount of an analyte of interest in a sample, the assay device comprising:

a sample receiving liquid container comprising a first openable liquid seal and a second openable liquid seal;

an opening means capable of opening the first liquid seal; and

an assay means for determining the presence and/or amount of an analyte of interest in the sample.

2. The assay device according to claim 1, wherein the second liquid seal fluidically separates the liquid container from the assay means.

3. The assay device according to claim 1, wherein the liquid container comprises a single liquid chamber.

4. The assay device according to claim 1, wherein the assay means comprises a liquid pathway.

5. The assay device according to claim 4, wherein the liquid pathway comprises a porous flow through matrix.

6. The assay device according to claim 5, wherein the porous flow through matrix comprises a lateral flow carrier.

7. The assay device according to claim 6, wherein the lateral flow carrier comprises a plurality of porous materials.

8. The assay device according to claim 6, wherein the lateral flow carrier comprises nitrocellulose.

9. The assay device according to claim 1, wherein the opening means comprises a puncturing means.

10. The assay device according to claim 1, wherein the first and/or second liquid seals are puncturable.

11. The assay device according to claim 1, comprising a sampling device.

12. The assay device according to claim 1, comprising a housing encasing the assay means.

13. The assay device according to claim 1, comprising a means capable of receiving a sampling device.

14. The assay device according to claim 13, wherein the means capable of receiving a sampling device is a hollow neck portion extending upwards from the liquid container.

15. The assay device according to claim 14, wherein the hollow neck portion comprises one or more projections extending into the bore of the neck portion.

16. The assay device according to claim 15, wherein the one or more projections are one or more fins.

17. The assay device according to claim 1, comprising two or more liquid pathways.

18. The assay device according to claim 1, comprising an immunoassay and/or an enzyme assay means.

19. The assay device according to claim 1, which is for the detection of bacterial vaginosis and/or Candida in a human bodily sample.

20. The assay device according to claim 1, wherein the assay means comprises an origin specific assay control means.

21. The assay device according to claim 20, wherein the assay control means comprises an anti-human Ig antibody.

22. An assay kit comprising the assay device of claim 1 in combination with one or more sampling devices.

23. The assay kit of claim 22, wherein the one or more sampling devices are one or more swabs.

24. A method of determining the presence and/or amount of an analyte of interest in a sample, comprising the steps of:

contacting the sample with the opening means of an assay device of claim 1, thereby opening the first openable liquid seal of the liquid container;

inserting the sample into the liquid container, which further contains a liquid;

opening the second openable liquid seal; and

allowing the liquid to flow from the container to the assay means to be assayed for the analyte of interest.

25. A puncturing device comprising:

a member defining an aperture;

one or more puncturing elements, each puncturing element comprising a first end attached to the member and a second end extending into the aperture, the second end being movable in relation to the member and being capable of puncturing a puncturable material.

26. The puncturing device of claim 25, further comprising means for attachment to a liquid container comprising a liquid seal.

27. The puncturing device of claim 25, wherein each puncturing element is attached to an inner surface of the member, the inner surface being a surface which faces the aperture.

28. The puncturing device of claim 25, wherein each puncturing element forms an integral part of the member.

29. The puncturing device of claim 25, wherein each puncturing element is formed from a resilient material.

30. The puncturing device of claim 25, wherein the second end of each puncturing element comprises a sharp point capable of puncturing a puncturable material.

31. The puncturing device of claim 25, wherein each puncturing element comprises an upper projection defining a surface of contact between the puncturing element and an item to be inserted through the aperture of the puncturing device.

32. The puncturing device of claim 31, wherein each puncturing element comprises a lower projection which is positioned on the opposite side of the puncturing element to the upper projection and which is for puncturing the puncturable material.

33. The puncturing device of claim 32, wherein the lower projection forms a cutting surface.

34. The puncturing device of claim 25, wherein each puncturing element has an arm portion linking the first and second ends of each puncturing element, and wherein the width of the middle of the arm portion is greater than the width of the upper and lower surfaces of the arm portion, the upper surface defined as the surface facing an item to be inserted through the device, and the lower surface defined as the surface facing the puncturable material.

35. The puncturing device of claim 25, in combination with a liquid container having one or a plurality of liquid seals formed of a puncturable material.

36. A liquid container having a plurality of puncturable liquid seals and a puncturing means within the container which is capable of puncturing one of the liquid seals.

37. The liquid container of claim 36, wherein the container comprises a first liquid seal at an upper end of the container and a second liquid seal at a lower end of the container.

38. The liquid container of claim 36, wherein the puncturing means comprises one or more puncturing elements attached to the inner surface of the container.

39. The liquid container of claim 38, wherein each of the one or more puncturing elements comprises a second end capable of puncturing a liquid seal, and one or more arm portions emanating from the second end and attaching to the inner surface of the container.

45. The liquid container of claim 40, comprising the features of the liquid container of claim 36.

40. A liquid container comprising a plurality of deflectable protrusions extending into the inner space of the liquid container from the inner side walls of the container.

41. The liquid container of claim 40, wherein the deflectable protrusions are integral with the liquid container.

42. The liquid container of claim 40, wherein the deflectable protrusions extend into the inner space of the container at an angle in the range of from 90°

to 1°

to the inner wall of the container.

43. The liquid container of claim 40, wherein the deflectable protrusions are formed of a resilient material.

44. The liquid container of claim 40, wherein the deflectable protrusions comprise an area of reduced cross sectional thickness immediately adjacent the inner wall of the container.