Diagnostic Device

• US 20080248517A1
• Filed: 06/10/2008
• Published: 10/09/2008
• Est. Priority Date: 12/21/2001
• Status: Abandoned Application

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Kaylor, Rosann Marie, Quirk, Stephen, Lyng, Robert John
• Application Number:
  US12/136,154
• Publication Number:
  US 20080248517A1
• Time in Patent Office: Days
• US Class Current: 435/30
• CPC Class Codes: G01N 21/4788 Diffraction for sizing particles G01N15/0205
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Diagnostic devices for detecting the presence of an analyte in a sample are provided. Devices of the present invention comprise a means for inducing a pressure differential on a sample to direct the sample to a test surface. In one embodiment, the means for inducing a pressure differential on a sample to direct the sample to a test surface comprises a syringe that can be used to draw a sample from an opening to a test surface. In other embodiments, the device also provides means for diluting a sample. In yet other embodiments, the device also provides a means

Claims

1-34. -34. (canceled)

35. A method for testing a sample comprising:

introducing a sample into the opening of a diagnostic device comprising a syringe having a piston, the diagnostic device further comprising a test strip removably attached to the diagnostic device housing, wherein the test strip defines a test surface;

inducing a first negative pressure differential on the sample by engaging the syringe to position the piston to a first indicator, the first indicator positioned to correspond to a pressure differential that directs the sample through a first channel and into a first chamber;

inducing a second negative pressure differential by engaging the syringe to position the piston to a second indicator, the second indicator positioned to correspond to a pressure differential that directs the sample from the first chamber to the test surface and thereafter removing an unreacted portion of the sample from the test surface, through a second channel and into a second chamber.

36. The method of claim 35, wherein the test surface is a diffraction-based test surface.

37. The method of claim 36, wherein the device further comprises diffraction-enhancing elements.

38. The method of claim 36, wherein the test surface is defined by a polymer film or metal-coated polymer film.

39. The method of claim 35, wherein the second chamber has a volume sufficient to contain the entire sample.

40. The method of claim 35, further comprising directing the sample from the opening through a third channel and into a third chamber located upstream of the first chamber, the third chamber in fluid communication with the first channel.

41. The method of claim 40, wherein the third chamber comprises a means for separating one or more components from the sample comprising a filter, membrane, film, nonwoven, paper, precipitating agent, cell lysing agent, or combination thereof.

42. The method of claim 41, wherein the means for separating one or more components from the sample removes red blood cells from the sample.

43. The method of claim 40, wherein the third chamber comprises a means for diluting the sample comprising a diluent.

44. The method of claim 40, wherein the diagnostic device further comprises a third indicator corresponding to a third piston position that indicates the sample has reached the third chamber.

45. The method of claim 35, further comprising applying the test surface with an analyte-specific binder.

46. The method of claim 35, wherein the first channel is formed by a capillary tube.

47. The method of claim 35, wherein the sample is blood.

48. A method for testing a sample comprising:

introducing a sample into the opening of a diagnostic device comprising a syringe having a piston, the diagnostic device further comprising a test strip wherein the test strip defines a test surface;

inducing a first negative pressure differential on the sample by engaging the syringe to position the piston to a third indicator, the third indicator positioned to correspond to a pressure differential that directs the sample through a third channel and into a third chamber;

inducing a second negative pressure differential by engaging the syringe to position the piston to a first indicator, the first indicator positioned to correspond to a pressure differential that directs the sample from a third chamber through a first channel and into a first chamber;

inducing a third negative pressure differential by engaging the syringe to position the piston to a second indicator, the second indicator positioned to correspond to a pressure differential that directs the sample from the first chamber to the test surface and thereafter removing an unreacted portion of the sample from the test surface, through a second channel and into a second chamber.

49. The method of claim 48, wherein the test strip is removably attached to the diagnostic device housing.

50. The method of claim 48, wherein the test surface is a diffraction-based test surface.

51. The method of claim 50, wherein the device further comprises diffraction-enhancing elements.

52. The method of claim 50, wherein the test surface is defined by a polymer film or metal-coated polymer film.

53. The method of claim 48, wherein the second chamber has a volume sufficient to contain the entire sample.

54. The method of claim 48, wherein the third chamber comprises a means for separating one or more components from the sample comprising a filter, membrane, film, nonwoven, paper, precipitating agent, cell lysing agent, or combination thereof.

55. The method of claim 54, wherein the means for separating one or more components from the sample removes red blood cells from the sample.

56. The method of claim 48, wherein the third chamber comprises a means for diluting the sample comprising a diluent.

57. The method of claim 48, further comprising applying the test surface with an analyte-specific binder.

58. The method of claim 48, wherein the sample is blood.