Tester for automated identification of analytes in bodily fluids

• US 20030171697A1
• Filed: 12/04/2002
• Published: 09/11/2003
• Est. Priority Date: 12/04/2001
• Status: Abandoned Application

• Current Assignee: Dave Smith, Eric Waltzer, Greg Liang, Mike Smith, Roger Tatum, Thomas J. Foley
• Original Assignee: Dave Smith, Eric Waltzer, Greg Liang, Mike Smith, Roger Tatum, Thomas J. Foley
• Inventors: Liang, Greg, Smith, Dave, Smith, Mike, Waltzer, Eric, Tatum, Roger, Foley, Thomas J.
• Application Number:
  US10/310,650
• Publication Number:
  US 20030171697A1
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: B01F 2101/23 Mixing of laboratory samples e.g. in preparation of analysing or testing properties of materials
• CPC Class Codes: B01F 33/452 using independent floating stirring elements
• CPC Class Codes: B01F 33/81 Combinations of similar mixers, e.g. with rotary stirring devices in two or more receptacles
• CPC Class Codes: B01F 33/812 in two or more alternative mixing receptacles, e.g. mixing in one receptacle and dispensing from another receptacle
• CPC Class Codes: B01F 35/713 comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges containers or packages per se B65D
• CPC Class Codes: B01F 35/7137 Piercing, perforating or melting membranes or closures which seal the compartments
• CPC Class Codes: B01F 35/7161 the containers being connected coaxially before contacting the contents
• CPC Class Codes: B01F 35/7163 the containers being connected in a mouth-to-mouth, end-to-end disposition, i.e. the openings are juxtaposed before contacting the contents
• CPC Class Codes: B01F 35/7174 using pistons, plungers or syringes
• CPC Class Codes: B01F 35/754251 reciprocating in the mixing receptacle
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2300/041 Connecting closures to device or container
• 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 2400/0478 pistons
• CPC Class Codes: B01L 2400/0622 distribution valves, valves having multiple inlets and/or outlets, e.g. metering valves, multi-way valves
• 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: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• 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 2035/00158 : Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 33/48714 : for determining substances foreign to the organism, e.g. drugs or heavy metals drugs by chemical analysis G01N33/94
• CPC Class Codes: G01N 33/54313 : the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54373 : involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G01N 33/98 : involving alcohol, e.g. ethanol in breath
• CPC Class Codes: Y10T 137/7036 : Jacketed
• CPC Class Codes: Y10T 156/1002 : with permanent bending or reshaping or surface deformation of self sustaining lamina
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A system, method, and assembly are provided for identifying one or more analytes within bodily fluids, such as saliva. The system includes an analyte tester, an oral aspirator, a conduit that is in fluid communication between the oral aspirator and the tester, and a pump in fluid communication with the conduit. In this manner, the aspirated oral fluid can be pumped directly from the aspirator into the analyte tester for identification of one or more oral fluid analytes. The analyte tester can be a flow immunoassay tester that identifies the five NIDA drugs-of-abuse, and can be configured to identify up to ten different drugs or other analytes. The analyte tester can also be portable, so that it can be conveniently used areas remote from laboratories. The tester may include a chemistry cassette and a test console configured for receiving the chemistry cassette. In this case, the conduit may be in fluid communication with the chemistry cassette. A user interface may also be provided for entering test information (e.g., a specific test selection or test panel customization) and for conveying test results (e.g., using a display or printer).

Claims

1. A system for testing oral fluid, comprising:

an analyte tester configured for identifying one or more oral fluid analytes;

an oral aspirator;

a conduit have a first end in fluid communication with said oral aspirator and a second end in fluid communication with said tester; and

a pump in fluid communication with said conduit.

2. The system of claim 1, wherein said one or more oral fluid analytes comprises one or more drugs.

3. The system of claim 1, wherein said one or more oral fluid analytes comprises one or more illicit drugs.

4. The system of claim 1, wherein said one or more oral fluid analytes comprises a plurality of different oral fluid analytes.

5. The system of claim 1, wherein said one or more oral fluid analytes comprises five or more different oral fluid analytes.

6. The system of claim 1, wherein said tester comprises an immunoassay tester.

7. The system of claim 1, wherein said tester comprises a flow immunoassay tester.

8. The system of claim 1, wherein said pump comprises a vacuum source.

9. The system of claim 1, wherein said tester is portable.

10. The system of claim 1, wherein said tester comprises a test console and a chemistry cassette, said test console configured for receiving said chemistry cassette.

11. The system of claim 10, wherein said second end of said conduit is in fluid communication with said chemistry cassette.

12. The system of claim 1, further comprising a user interface for entering test input information from an operator and conveying test results to said operator.

13. The system of claim 12, wherein said user interface comprises a display for displaying said test results.

14. The system of claim 12, wherein said user interface comprises a printer for printing said test results.

15. The system of claim 12, wherein said test input information comprises a selection of one or more analytes to be identified by the tester.

16. The system of claim 12, wherein said test input information comprises a customization of a test panel.

17. A system for testing bodily fluid, comprising:

an analyte tester configured for identifying one or more analytes in less than 1 ml of bodily fluid;

a sample collection interface device;

a conduit have a first end in fluid communication with said sample collection interface device and a second end in fluid communication with said tester; and

a pump in fluid communication with said conduit.

18. The system of claim 17, wherein said pump is configured for pumping bodily fluid through said conduit at a rate of less than 200 μ

l/min.

19. The system of claim 17, wherein said one or more oral fluid analytes comprises one or more drugs.

20. The system of claim 17, wherein said one or more oral fluid analytes comprises one or more illicit drugs.

21. The system of claim 17, wherein said one or more oral fluid analytes comprises a plurality of different oral fluid analytes.

22. The system of claim 17, wherein said one or more oral fluid analytes comprises five or more different oral fluid analytes.

23. The system of claim 17, wherein said tester comprises an immunoassay tester.

24. The system of claim 17, wherein said tester comprises a flow immunoassay tester.

25. The system of claim 17, wherein said pump comprises a vacuum source.

26. The system of claim 17, wherein said tester is portable.

27. The system of claim 17, wherein said tester comprises a test console and a chemistry cassette, said test console configured for receiving said chemistry cassette.

28. The system of claim 27, wherein said second end of said conduit is in fluid communication with said chemistry cassette.

29. The system of claim 17, wherein said sample collection interface device comprises an oral aspirator.

30. A method of testing oral fluid, comprising:

pumping an oral fluid sample from a subject to an analyte tester; and

identifying within said analyte tester one or more analytes contained in said oral fluid sample.

31. The method of claim 30, wherein said one or more analytes comprises one or more drugs.

32. The method of claim 30, wherein said one or more analytes comprises one or more illicit drugs.

33. The method of claim 30, wherein said one or more analytes comprises a plurality of different oral fluid analytes.

34. The method of claim 30, wherein said one or more analytes comprises five or more different oral fluid analytes.

35. The method of claim 30, wherein said one or more analytes is identified using an immunoassay technique.

36. The method of claim 30, wherein said one or more analytes is identified using a flow immunoassay technique.

37. The method of claim 30, wherein said sample is aspirated from said subject.

38. The method of claim 30, wherein said one or more analytes are semi-quantitatively identified.

39. The method of claim 30, wherein said one or more analytes are quantitatively identified.

40. The method of claim 30, wherein said pumping and identifying steps are performed in less than ten minutes.

41. A method of testing bodily fluid, comprising:

pumping less than 1 ml of a bodily fluid sample from a subject to an analyte tester; and

identifying with said analyte tester one or more analytes contained in said sample.

42. The method of claim 41, wherein said bodily fluid sample is pumped at a rate of less than 200 μ

l/min.

43. The method of claim 41, wherein said one or more analytes comprises one or more drugs.

44. The method of claim 41, wherein said one or more analytes comprises one or more illicit drugs.

45. The method of claim 41, wherein said one or more analytes comprises a plurality of different oral fluid analytes.

46. The method of claim 41, wherein said one or more analytes comprises five or more different oral fluid analytes.

47. The method of claim 41, wherein said one or more analytes is identified using an immunoassay technique.

48. The method of claim 41, wherein said one or more analytes is identified using a flow immunoassay technique.

49. The method of claim 41, wherein said sample is aspirated from said subject.

50. The method of claim 41, wherein said one or more analytes are quantitatively identified.

51. The method of claim 41, wherein said pumping and identifying steps are performed in less than ten minutes.

52. A cassette assembly for use with a test console, comprising:

a chemistry cassette receivable within said test console, wherein said chemistry cassette enables said test console to identify one or more bodily fluid analytes; and

a bodily fluid sample collection assembly configured for being in fluid communication with said chemistry cassette.

53. The cassette assembly of claim 52, wherein said sample collection assembly is connected to said chemistry cassette.

54. The cassette assembly of claim 52, wherein said sample collection assembly comprises a sample collection interface device, a sample collection chamber, and a conduit in fluid communication between said sample collection interface device and said sample collection chamber.

55. The cassette assembly of claim 54, wherein said sample collection chamber is mounted within said chemistry cassette.

56. The cassette assembly of claim 54, wherein said sample collection chamber is configured for being in fluid communication with a pump.

57. The cassette assembly of claim 52, wherein said sample collection assembly is an oral fluid sample collection assembly.

58. The cassette assembly of claim 57, wherein said sample collection assembly comprises an oral aspirator, a sample collection chamber, and a conduit in fluid communication between said oral aspirator and said sample collection chamber.

59. The cassette assembly of claim 52, wherein said one or more bodily fluid analytes comprises one or more drugs.

60. The cassette assembly of claim 52, wherein said one or more bodily fluid analytes comprises one or more illicit drugs.

61. The cassette assembly of claim 52, wherein said one or more bodily fluid analytes comprises a plurality of different bodily fluid analytes.

62. The cassette assembly of claim 52, wherein said one or more bodily fluid analytes comprises five or more different bodily fluid analytes.

63. The cassette assembly of claim 52, wherein said chemistry cassette is an immunoassay cassette.

64. The cassette assembly of claim 52, wherein said chemistry cassette is a fluid immunoassay cassette.