Portable blood count monitor

• US 10,024,858 B2
• Filed: 03/12/2014
• Issued: 07/17/2018
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: TIRHR, LLC
• Original Assignee: Tahoe Institute For Rural Health Research, LLC, Regents of the University of California (University of California)
• Inventors: Smith, Zachary, Gao, Tingjuan, Lane, Stephen, Wachmann-Hogiu, Sebastian, Dwyre, Denis, Heifetz, Laurence, Hood, James, Matthews, Dennis, Tatsukawa, Keith
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US14/207,274
• Publication Number:
  US 20140273064A1
• Time in Patent Office: 1,588 Days
• CPC Class Codes: G01N 33/5017 for testing neoplastic activity
• CPC Class Codes: G01N 33/57438 of liver, pancreas or kidney

Abstract

This disclosure describes the development of a sample preparation, measurement, and analysis method that permits accurate characterization of red blood cells, platelets, and white blood cells, including a 3-part differential of the white blood cells count, to be performed on small volumes of a biological sample. This method is compatible with compact and portable instrumentation that permits the sample collection to be performed in a subject'"'"'s home and analysis to be performed elsewhere by transmission of the data to a laboratory or doctor'"'"'s office.

Claims

1. A device comprising:

a) a slide configured to receive a body fluid, wherein the slide comprises;

i) a first chamber, wherein the first chamber contains a first reagent that detects a red blood cell in the body fluid by sphering the red blood cell; and

ii) a second chamber, wherein the second chamber contains a second reagent that differentiates a white blood cell in the body fluid from the red blood cell,

wherein the first chamber and the second chamber are connected by a fluidic channel; and

b) an imaging system that acquires an image of the red blood cell from the first chamber and an image of the white blood cell from the second chamber of the slide.

2. The device of claim 1, further comprising a transmitter, wherein the transmitter is configured to transmit the image of the red blood cell and the image of the white blood cell to a receiver.

3. The device of claim 2, wherein the transmission is wireless.

4. The device of claim 2, wherein the transmission and the receiver are at least one mile apart.

5. The device of claim 1, wherein the body fluid is urine.

6. The device of claim 1, wherein the body fluid is blood.

7. The device of claim 1, wherein the slide and the imaging system are contained in a common housing.

8. The device of claim 7, wherein the slide is removable.

9. The device of claim 1, wherein the fluidic channel is across a surface of the slide.

10. The device of claim 1, wherein the slide further comprises a port, wherein the port is configured to receive the body fluid and pass the body fluid through the fluidic channel to the first chamber or the second chamber.

11. The device of claim 1, wherein the slide further comprises a third chamber, wherein the third chamber contains a third reagent that stains a platelet in the body fluid.

12. The device of claim 1, wherein the slide is configured to receive from about 1 microliter to about 5 microliters of the body fluid.

13. The device of claim 1, wherein the body fluid is saliva.

14. The device of claim 1, wherein the slide further comprises at least one control chamber, wherein the control chamber contains a control analyte.

15. The device of claim 1, wherein the second reagent stains the white blood cell.

16. The device of claim 1, wherein the device has a mass of no greater than 2,000 g, wherein the device has a minimum total mass of about 100 g.

17. A device comprising:

a) a slide configured to receive a body fluid, wherein the slide comprises a first chamber and a second chamber, wherein the first chamber contains a first reagent that spheres a red blood cell in the body fluid, and the second chamber contains a second reagent that differentiates a white blood cell in the body fluid from the red blood cell;

b) an imaging system that acquires an image of the red blood cell from the first chamber and an image of the white blood cell from the second chamber of the slide; and

c) a transmitter configured to wirelessly-transmit the image of the red blood cell from the first chamber and the image of the white blood cell from the second chamber of the slide over a distance of at least one mile.

18. The device of claim 17, wherein the device has a mass of no greater than 2,000 g, wherein the device has a minimum total mass of about 100 g.

19. The device of claim 17, wherein the slide and the imaging system are contained in a common housing.

20. The device of claim 19, wherein the slide is removable.

21. The device of claim 17, wherein the body fluid is saliva.

22. The device of claim 17, wherein the body fluid is blood.

23. The device of claim 17, wherein the slide further comprises a third chamber, wherein the third chamber contains a third reagent that stains a platelet in the body fluid.

24. The device of claim 17, wherein the slide is configured to receive from about 1 microliter to about 5 microliters of the body fluid.

25. The device of claim 17, wherein the body fluid is urine.

26. The device of claim 17, wherein the slide further comprises a port, wherein the port is configured to receive the body fluid and pass the body fluid through a fluidic channel to the first chamber or the second chamber.

27. The device of claim 17, wherein the slide further comprises at least one control chamber, wherein the control chamber contains a control analyte.

28. The device of claim 17, wherein a fluidic channel is across a surface of the slide.

29. The device of claim 17, wherein the second reagent stains the white blood cell.

30. A method for analyzing a body fluid, the method comprising:

a) providing the body fluid to a slide, wherein the slide comprises a first chamber and a second chamber, wherein the first chamber and the second chamber are connected by a fluidic channel;

b) detecting in the first chamber a red blood cell in the body fluid with a first reagent that spheres the red blood cell;

c) detecting in the second chamber a white blood cell in the body fluid with a second reagent that differentiates the white blood cell in the body fluid from the red blood cell; and

d) acquiring by an imaging system an image of the red blood cell from the first chamber and an image of the white blood cell from the second chamber of the slide.

31. The method of claim 30, wherein the slide is configured to receive from about 1 microliter to about 5 microliters of the body fluid.

32. The method of claim 30, wherein the body fluid is saliva.

33. The method of claim 30, wherein the body fluid is blood.

34. The method of claim 30, wherein the slide further comprises a third chamber, wherein the method further comprises staining in the third chamber a platelet in the body fluid with a third reagent.

35. The method of claim 30, wherein the fluidic channel is across a surface of the slide.

36. The method of claim 30, wherein the device further comprises a port, wherein the port is configured to receive the body fluid and pass the body fluid through the fluidic channel to the first chamber or the second chamber.

37. The method of claim 30, further comprising transmitting the image of the red blood cell from the first chamber and the image of the white blood cell from the second chamber to a receiver by a transmitter.

38. The method of claim 37, wherein the transmission is wireless.

39. The method of claim 37, wherein the transmitter and the receiver are at least one mile apart.

40. A system comprising:

a) a device comprising;

i) a slide configured to receive a body fluid, wherein the slide comprises a first chamber that contains a first reagent that spheres a red blood cell and a second chamber that contains a second reagent that differentiates a white blood cell in the body fluid from the red blood cell, wherein the first chamber and the second chamber are connected by a fluidic channel;

ii) an imaging system that acquires an image of the red blood cell from the first chamber and an image of the white blood cell from the second chamber of the slide; and

iii) a transmitter, wherein the transmitter wirelessly transmits the image from the first chamber and the image from the second chamber; and

b) a receiver that receives the wirelessly-transmitted image from the first chamber and the wirelessly-transmitted image from the second chamber from the transmitter, wherein the transmitter and the receiver are configured to communicate over a distance of at least 1 mile.

41. The system of claim 40, wherein the device has a mass of no greater than 2,000 g, wherein the device has a minimum total mass of about 100 g.

42. The system of claim 40, wherein the slide, the imaging system, and the transmitter are contained in a common housing.

43. The system of claim 40, wherein the body fluid is saliva.

44. The system of claim 40, wherein the body fluid is blood.

45. The system of claim 40, wherein the slide further comprises a third chamber, wherein the third chamber contains a third reagent that stains a platelet in the body fluid.

46. The system of claim 40, wherein the slide is configured to receive from about 1 microliter to about 5 microliters of the body fluid.

47. The system of claim 40, wherein the slide further comprises a port, wherein the port is configured to receive the body fluid and pass the body fluid through the fluidic channel to the first chamber or the second chamber.

48. The system of claim 40, wherein the slide further comprises at least one control chamber, wherein the control chamber contains a control analyte.

49. The system of claim 40, wherein the slide and the imaging system are contained in a common housing.

50. The system of claim 40, wherein the body fluid is urine.

51. A kit comprising:

a) a device comprising;

i) a slide configured to receive a body fluid, wherein the slide comprises a first chamber and a second chamber, wherein the first chamber and the second chamber are connected by a fluidic channel; and

ii) an imaging system that acquires an image of a red blood cell from the first chamber and an image of a white blood cell from the second chamber of the slide;

b) a first reagent that spheres the red blood cell in the body fluid in the first chamber; and

c) a second reagent that differentiates the white blood cell in the body fluid from the red blood cell in the second chamber.

52. The kit of claim 51, wherein the slide further comprises a port, wherein the port is configured to receive the body fluid and pass the body fluid through the fluidic channel to the first chamber or the second chamber.

53. The kit of claim 51, wherein the slide further comprises a third chamber, wherein the third chamber comprises a third reagent that stains a platelet in the body fluid.

54. The kit of claim 51, wherein the slide is configured to receive from about 1 microliter to about 5 microliters of the body fluid.

55. The kit of claim 51, wherein the slide further comprises at least one control chamber.

56. The kit of claim 51, wherein the slide and the imaging system are contained in a common housing.

57. The kit of claim 51, wherein the slide is removable.

58. The kit of claim 51, wherein the fluidic channel is across a surface of the slide.

59. The kit of claim 51, wherein the second reagent stains the white blood cell.

60. The kit of claim 51, wherein the body fluid is blood.

61. The kit of claim 51, wherein the body fluid is saliva.

62. The kit of claim 51, wherein the body fluid is urine.

63. The kit of claim 51, wherein the device has a mass of no greater than 2,000 g, wherein the device has a minimum total mass of about 100 g.