SPECIMEN SAMPLE COLLECTION DEVICE AND TEST SYSTEM

• US 20120282154A1
• Filed: 06/21/2011
• Published: 11/08/2012
• Est. Priority Date: 01/28/2004
• Status: Active Grant

• Current Assignee: Bamburgh Marrsh LLC (MDM Group, Inc.)
• Original Assignee: Bamburgh Marrsh LLC (MDM Group, Inc.)
• Inventors: SLOWEY, PAUL D., Wickstead, James, Seritella, Keith, Ennis, John, Herrig, Richard, Giddings, Jason, Forbes, Brian, Smith, Paul
• Granted Patent: US 9,645,091 B2
• Time in Patent Office: Days
• US Class Current: 422/401
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A portable, hand-held electro-optical reader and specimen sample collector is provided, including an absorbent pad, one or more test strips contained in the collector handle to provide observable results through a window, the handle insertable into the reader for immediate recording and analysis. The system includes means to automatically provide subject and test specific data with the test results and retain samples for later verification analysis.

Claims

1. A specimen sample collection and test system comprising a saliva sample collector and electro-optical reader, the sample collector including:

a handle having opposing first and second ends and opposing first and second sides, a sufficiency indicator, and a window to observe indications from a test strip;

an absorbent pad partially contained within the handle and extending out from the handle first end;

a pad compression tube insertable over the absorbent pad and around the first end of the handle, the pad compression tube including one or more collection tube ports to receive a collection tube, wherein the window remains unobscured when the pad compression tube is fully inserted over the handle first end;

one or more test strips contained within the handle in fluid communication with the absorbent pad, the one or more test strips to detect a substance and produce an observable indication through the window in the handle; and

,

the electro-optical reader including a sample collector port to receive the handle second end at least up to and including the window, the electro-optical reader to detect the observable indication through the window and record the result.

2. The system of claim 1, further comprising a progressive locking mechanism having a first part disposed on the handle and a second part disposed on the pad compression tube, to resist separation of a pad compression tube inserted over the absorbent pad and around the handle first end.

3. The system of claim 2, further comprising:

the handle including first and second projections disposed on first and second handle sides, respectively;

the pad compression tube including opposing first and second channels extending lengthwise along opposing pad compression tube side walls to frictionally engage the first and second projections, respectively.

4. The system of claim 2, further comprising:

the handle including first and second unidirectional locking teeth disposed on the handle first and second sides, respectively; and

,

the pad compression tube including a plurality of locking holes on opposing sides of the pad compression tube to lockingly engage the locking teeth, the locking holes spaced apart lengthwise on the pad compression tube to lock the pad compression tube over the handle first end in progressively tighter compression positions.

5. The system of claim 1, further comprising:

a collection tube sealingly connectable to at least one of the pad compression tube one or more collection tube ports, the collection tube including one or more sample chambers, wherein when the collection tube is connected to the pad compression tube at least one of the corresponding one or more sample chambers is in fluid communication with the pad compression tube and the absorbent pad.

6. The system of claim 1, further comprising a plurality of alternating lands and grooves disposed on the interior wall of the pad compression tube proximal to the collection tube ports, the grooves in fluid communication with the collection tube ports.

7. The system of claim 1, further comprising a collector dam insertable over the absorbent pad against the handle first end, the collector dam in sealing contact with the absorbent pad and the inside wall surface of the pad compression tube, and wherein the collector dam permits liquid sample to migrate along the absorbent pad during collection, but prevents flow when the absorbent pad and handle are inserted into the pad compression tube.

8. The system of claim 1, the electro-optical reader further comprising:

a housing having an aperture to view and operate a programmable data handling device touch screen;

an imaging device mounted within the housing and having a field of view oriented to image a selected portion of a sample collector handle inserted into the sample collector port;

an imaging processor mounted within the housing and in electronic communication with the imaging device and data handing device, the imaging processor to at least receive imaging data from the imaging device, process the imaging data for use by the data handing device, and transmit the imaging data to the data handling device;

a programmable data handling device removably mounted within the housing, the data handling device including a touch screen, wherein the touch screen is aligned with the housing aperture when mounted within the housing.

9. The system of claim 8, further comprising a mechanically adjustable mounting to receive and retain the imaging device within the housing and align the imaging device field of view.

10. The system of claim 8, further comprising wherein the programmable data handling device is a self-contained unit.

11. The system of claim 1, further comprising:

collector identification indicia disposed on the sample collector handle so as to be received within the sample collector port when the sample collector handle is inserted into the collector port; and

,

the reader including collector identification indicia sensing means.

12. The system of claim 11, further comprising wherein the collector identification indicia includes a plurality of color markings.

13. The system of claim 11, further comprising:

the collector identification indicia sensing means including one or more electro-mechanical switches to be selectively actuated by corresponding structures on a sample collector handle.

14. The system of claim 1, the reader further comprising a sample collector presence detector to detect a sample collector handle inserted into the receiving portion.

18. The system of claim 1, further comprising an optical target disposed on the sample collector to be within the imaging device field of view when the sample collector handle is inserted into the receiving portion.

19. The system of claim 1, further comprising:

the sample collector including an area on the handle proximal to the window to receive a optical data label, such that the optical data label is within the imaging device field of view when the sample collector handle is inserted into the sample collector port, the optical data to include sample-specific data.

20. The system of claim 1, further comprising:

the sample collector including optical data indicia identifying the sample collector, such that the optical data indicia is within the imaging device field of view when the sample collector handle is inserted into the sample collector port.

21. The system of claim 8, further comprising a light source mounted within the housing and oriented to illuminate the portion of a sample collector handle inserted within the sample collector port, the light source selectively activatable to illuminate the handle during imaging.

22. The system of claim 8, further comprising a light source mounted within the housing and oriented to illuminate a sample collector handle inserted within the sample collector receiving port, the light source selectively activatable by an electronic signal from the imaging processor.

23. The system of claim 8, further comprising a lens element disposed between the sample collector port and the imaging device.

24. The system of claim 8, further comprising an optical filter disposed between the sample collector port and the imaging device.

25. The system of claim 24, further comprising wherein the optical filter is a polarizing filter.

26. The system of claim 8, further comprising a shield within the housing disposed between the sample collector receiving port interior and housing interior.

27. The system of claim 8, the data handling device further including wireless communication means to transmit and receive data.

28. The system of claim 8, further comprising a printer in electronic communication with the data handling device.

29. The system of claim 28 further comprising:

wherein the printer is mounted within the housing.

30. The system of claim 8, further comprising a selectively activated light source directed outwardly through the sample collector port.

31. The system of claim 30, further comprising:

the receiving port illuminator to be deactivated by a signal from the collector presence detector.

32. The system of claim 1, further comprising:

at least one test strip including a control line extending transversely across the test strip and one or more indicator lines each disposed at a predetermined distance downstream from the control line.

33. The system of claim 1, wherein the one or more test strips comprise first and second test strips, each test strip in fluid communication with the absorbent pad.

34. The system of claim 33, further comprising the first and second test strips each to detect the presence of at least one substance in common in a sample.

35. The system of claim 33, further comprising the first and second test strips each to detect the presence of different substances in a sample.

36. The system of claim 33, further comprising the first and second test strips each to detect the presence of a different substance in a sample, the different substances each correlating to the same condition of a test subject. (i.e. different markers for a given condition)

37. The system of claim 1, further comprising:

one or more membranes contained within the handle, each of the one or more membranes corresponding to a test strip and in fluid communication with the absorbent pad and the corresponding test strip.

38. The system of claim 1, further comprising:

a membrane in the handle; and

,

the one or more test strips including at least one single analyte test strip;

wherein the absorbent pad is in fluid communication with the single analyte test strip through the membrane.

39. The system of claim 1, further comprising:

a plurality of test strips in the handle; and

,

a plurality of membranes in the handle, each membrane corresponding to a single test strip;

wherein the absorbent pad is in fluid communication with each of the plurality of test strips through its corresponding membrane.

40. The system of claim 1, further comprising:

a plurality of analyte test strips in the handle; and

,

a single membrane in the handle;

wherein the absorbent pad is in fluid communication with each of the test strips through the membrane.

41. The system of claim 1, further comprising:

wherein the absorbent pad is split, divided into two parts and connected at a base of the absorbent pad.

42. The system of claim 1, further comprising:

wherein the sufficiency indicator is a light pipe.

43. The system of claim 42, the light pipe further comprising:

a first end surface with a marking, and a second surface in physical contact with the absorbent pad creating a refractive boundary, wherein the second surface is oriented at an angle of incidence to the first surface such that when the absorbent pad absorbs a sufficient liquid sample the refractive properties of the boundary alter the observability of the mark.

44. The system of claim 43, the further comprising a spacer contained within the handle, the spacer disposed between the absorbent pad and the handle structure to urge the absorbent pad against the light pipe second surface.

15. The system of claim 15, the presence detector comprising an electro-mechanical switch.

16. The system of claim 15, the presence detector comprising an optical switch.

17. The system of claim 15, the presence detector comprising an electro-magnetic switch.

45. A specimen sample collection device and test system comprising an electro-optical reader to receive a sample collector, the electro-optical reader further comprising:

a housing including an aperture to view and operate a programmable data handling device touch screen, and a sample collector port to receive a portion of a sample collector having one or more test strips to produce observable indications of the presence of selected substances within a test sample;

an imaging device mounted within the housing and having a field of view oriented to image a selected portion of the sample collector inserted into the sample collector port;

an imaging processor mounted within the housing and in electronic communication with the imaging device and data handing device, the imaging processor to at least receive imaging data from the imaging device, process the imaging data for use by the data handing device, and transmit the imaging data to the data handling device;

a programmable data handling device removably mounted within the housing, the data handling device including a touch screen, wherein the touch screen is aligned with the housing aperture when mounted within the housing.

46. The system of claim 45, further comprising a mechanically adjustable mounting to receive and retain the imaging device within the housing and align the imaging device field of view.

47. The system of claim 45, further comprising wherein the programmable data handling device is a self-contained unit.

48. The system of claim 45, further comprising sample collector identification means to identify the type of collector received within the sample collector port when a sample collector handle is inserted into the sample collector port.

49. The system of claim 45, the reader further comprising a sample collector presence detector to detect a sample collector inserted into the collector port.

50. The system of claim 49, the presence detector comprising an electro-mechanical switch.

51. The system of claim 49, the presence detector comprising an optical switch.

52. The system of claim 49, the presence detector comprising an electro-magnetic switch.

53. The system of claim 45, the reader further including detection means to detect an optical target disposed on a sample collector to be within the imaging device field of view when the sample collector handle is inserted into the receiving portion, the optical target to provide a reference to electronically adjust the orientation of an image received by the imaging device.

54. The system of claim 45, the reader further including means to receive, record, and interpret an optical data label placed on a sample collector proximal to the test strip window, such that the optical data label is within the imaging device field of view when the sample collector handle is inserted into the sample collector port, the optical data to include sample-specific data.

55. The system of claim 45, the reader further including means to receive, record, and interpret optical data indicia identifying the sample collector, the optical data indicia disposed within the imaging device field of view when the sample collector handle is inserted into the sample collector port.

56. The system of claim 45, the reader further comprising a light source mounted within the housing and oriented to illuminate the portion of a sample collector handle inserted within the sample collector port, the light source selectively activatable to illuminate the handle during imaging.

57. The system of claim 45, the reader further comprising a light source mounted within the housing and oriented to illuminate a sample collector handle inserted within the sample collector receiving port, the light source selectively activatable by an electronic signal from the imaging processor.

58. The system of claim 45, the reader further comprising a lens element disposed between the sample collector port and the imaging device.

59. The system of claim 45, the reader further comprising an optical filter disposed between the sample collector port and the imaging device.

60. The system of claim 59, further comprising wherein the optical filter is a polarizing filter.

61. The system of claim 45, the reader further comprising a shield within the housing disposed between the sample collector receiving port interior and housing interior.

62. The system of claim 45, the reader further comprising wireless communication means to transmit and receive data.

63. The system of claim 45, the reader further comprising a printer in electronic communication with the data handling device.

64. The system of claim 63 further comprising:

wherein the printer is mounted within the housing.

65. The system of claim 45, the reader further comprising a selectively activated light source directed outwardly through the sample collector port.

66. The system of claim 65, further comprising:

the receiving port illuminator to be deactivated by a signal from the collector presence detector.