In line test device and methods of use

• US 6,890,484 B2
• Filed: 10/22/2002
• Issued: 05/10/2005
• Est. Priority Date: 05/18/2001
• Status: Expired due to Term

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: ACON Laboratories Incorporated (Abbott Laboratories Incorporated)
• Inventors: Guan, Zhumin, Bautista, Lorraine
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/278,686
• Publication Number:
  US 20030129767A1
• Time in Patent Office: 931 Days
• Field of Search: 422/58, 422/61, 422/100, 422/102, 422/103, 436/165, 436/172, 435/288.2
• US Class Current: 422/412
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0644 rotary valves
• CPC Class Codes: B01L 2400/0677 phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• 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: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The present invention recognizes that it can be desirable to have a sample receiving chamber integral to or engageable with a test platform, such as a test platform that includes a test strip. The sample receiving chamber is preferably separate or separable from the test platform, but that need not be the case. Preferably, a fluid flow actuating device or structure, such as a valve separates the sample receiving chamber from the test platform. The present invention provides such a device and methods of use. A first aspect of the present invention is a test device that includes a sample receiving chamber and a test platform that preferably includes a test element. The sample receiving chamber preferably engages the test platform and is optionally separable therefrom. A second aspect of the present invention is a method of detecting an analyte in a sample, including: providing a sample, contacting the sample with a test device and detecting the analyte in the sample. The test device preferably includes a sample receiving chamber and a test platform that includes a test element. Preferably, the sample receiving chamber engages the test platform and optionally the sample receiving chamber is separable from the test platform.

Claims

1. A test device, comprising:

a) a sample receiving chamber having an open proximal end and a distal end;

said sample receiving chamber comprising a valve structure, said valve structure comprising, in combination, a male outlet port and a female receptor outlet port which engage one another to control fluid communication between the sample receiving chamber and a test platform;

b) a test platform that comprises a test element;

wherein a sample can be added to said sample receiving chamber through said open proximal end;

wherein said distal end of said sample receiving chamber engages said test platform;

wherein said sample receiving chamber is separable from said test platform;

wherein said sample receiving chamber, when separate from said test platform and containing a fluid, can engage said test platform and release said fluid into said test platform through said distal end such that said fluid contacts said test element; and

wherein at least a portion of said sample can be transferred from said sample receiving chamber to said test platform by approximately or substantially aligning said male insert outlet port and said female receptor outlet port to open said valve structure.

2. The test device of claim 1, wherein said open proximal end of said receiving chamber is optionally flared.

3. The test device of claim 1, wherein said sample receiving chamber is substantially cylindrical.

4. The test device of claim 1, wherein the inside of said sample receiving chamber optionally comprises a structure to facilitate extraction of a sample.

5. The test device of claim 1, wherein said sample receiving chamber can receive a sample on a sample collection device.

6. The test device of claim 1, wherein said sample receiving chamber comprises a key structure to engage said test platform.

7. The test device of claim 1, wherein said sample receiving chamber comprises a reagent.

8. The test device of claim 1, wherein said test platform comprises a housing.

9. The test device of claim 1, wherein said test platform comprises an opening or window to observe said test element.

10. The test device of claim 1, wherein said test platform comprises a key structure to engage said distal end of said sample receiving chamber.

11. The test device of claim 1, wherein said test element comprises a test strip.

12. The test device of claim 1, wherein said test element comprises an immunological test strip.

13. The test device of claim 1, wherein said test element detects a biological moiety.

14. The test device of claim 1, wherein said test element detects a hormone, a drug, a protein, an etiological agent or a portion thereof.

15. The test device of claim 1, wherein said test element comprises a sample application zone.

16. The test device of claim 1, wherein said test element comprises a detection zone.

17. The test device of claim 1, wherein said test element comprises a solid matrix capable of supporting lateral chromatographic or capillary flow.

18. The test device of claim 1, wherein said test element is directly or indirectly in fluid communication with said sample receiving chamber.

19. The test device of claim 1, wherein said sample receiving chamber when separate from said test platform, can hold a fluid.

20. The test device of claim 1, wherein said sample receiving chamber, when separate from said test platform and containing a fluid, can engage said test platform and release a portion of said fluid into said test platform such that said portion of said fluid contacts said test element.

21. The test device of claim 1, wherein said valve structure can be repeatedly opened and closed, further wherein said valve structure being opened when said male insert outlet port and said female receptor outlet port are approximately or substantially aligned, further wherein said valve structure being closed when said male insert outlet port and said female receptor outlet port are not approximately or substantially aligned.

22. The test device of claim 1, wherein said valve structure can optionally lock in an open or a closed position.

23. The test device of claim 1, wherein said valve structure further comprises a male insert and a female receptor, wherein said male insert comprises said male insert outlet port and said female receptor comprises said female receptor outlet port, wherein said approximately or substantially aligning said male insert outlet port and said female receptor outlet port is performed by altering a position of either said male insert or said female receptor.

24. The test device of claim 23, further comprising a seal structure positioned between said male insert and said female receptor, wherein said seal structure prevents or reduces sample leakage from said sample receiving chamber when said valve structure is in a closed position.

25. The test device of claim 24, wherein said seal structure is an O-ring.

26. The test device of claim 1, further comprising one or more filters to reduce particulate matter contacting said test element.

27. The test device of claim 1, further comprising a reagent.

28. The test device of claim 1, further comprising instructions.

29. The test device of claim 1, wherein said sample receiving chamber is substantially perpendicular to said test platform when said sample receiving chamber and said test platform are operably engaged.

30. A method of detecting an analyte in a sample, comprising:

providing a sample suspected of comprising an analyte;

contacting said sample with the test device of claim 1;

releasing said analyte from said sample receiving chamber; and

detecting said analyte in said sample.

31. The method of claim 30, wherein said sample is a biological sample.

32. The method of claim 30, wherein said sample is provided on a sample collection device.

33. The method of claim 30, wherein said sample is provided on a swab.

34. The method of claim 30, wherein said sample is extracted in said sample receiving chamber.

35. The method of claim 30, wherein said sample is extracted in said sample receiving chamber using an extraction solution.

36. The method of claim 30, wherein said analtye is a biological or chemical moiety.

37. The method of claim 30, wherein said analyte is extracted from said sample.

38. The method of claim 30, wherein said analtye is an etiological agent, derived from an etiological agent or extracted from an etiological agent.

39. The method of claim 30, wherein said sample is placed in said sample receiving chamber, optionally with a reagent;

wherein when said reagent is present, said reagent can be added to said sample receiving chamber before or after said sample is placed therein.

40. The method of claim 39, wherein said sample receiving chamber is optionally engaged with said test platform when said sample is contacted with said test device.

41. The method of claim 39, wherein said sample is contacted with said sample receiving chamber with a reagent.

42. The method of claim 39, wherein said sample with a reagent in said sample receiving chamber are allowed to mix or incubate in said sample receiving chamber.

43. The method of claim 39, wherein when said sample receiving chamber and said test platform are separate, a sample is provided in said sample receiving chamber with a reagent and said sample receiving chamber is then operably engaged with said test platform.

44. The method of claim 39, wherein when said sample receiving chamber and said test platform are separate, a sample is provided in said sample receiving chamber without a reagent and said sample receiving chamber is then operably engaged with said test platform.

45. The method of claim 44, wherein after said sample receiving chamber is operably engaged with said test platform, a reagent is added.

46. The method of claim 39, wherein sample is allowed to flow through a filter prior to contacting said test element.

47. The method of claim 39, wherein said valve structure actuates or modulates fluid flow between said sample receiving chamber and said test platform.