Real-Time Detection of Influenza Virus

• US 20070264629A1
• Filed: 05/09/2007
• Published: 11/15/2007
• Est. Priority Date: 05/10/2006
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, Holmes, Elizabeth A.
• Granted Patent: US 8,007,999 B2
• Time in Patent Office: Days
• US Class Current: 435/5
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/142 Preventing evaporation
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0874 Three dimensional network
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/049 vacuum
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: C12Q 1/701 Specific hybridization probes
• CPC Class Codes: G01N 2333/11 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/56983 Viruses

Abstract

The present invention provides system and methods for detecting an analyte indicative of an influenza viral infection in a sample of bodily fluid. The present invention also provides for systems and method for detection a plurality of analytes, at least two of which are indicative of an influenza viral infection in a sample of bodily fluid.

Claims

1. A system for detecting an analyte indicative of an influenza viral infection in a bodily fluid from a subject, comprising:

a) a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows a sample of bodily fluid suspected to contain said analyte to react with reactants contained within said assay assembly to yield a detectable signal indicative of the presence of said analyte;

b) a reader assembly comprising a detection assembly for detecting said detectable signal; and

c) a communication assembly for transmitting said detected signal to an external device.

2. The system of claim 1, wherein said sample of bodily fluid suspected to contain said analyte reacts with reactants contained within said assay assembly based on a protocol transmitted from said external device.

3. The system of claim 1, wherein said analyte is indicative of an influenza type A viral infection.

4. The system of claim 1, wherein said analyte is indicative of an influenza type B viral infection.

5. The system of claim 1, wherein said analyte is indicative of an influenza type C viral infection.

6. The system of claim 1, wherein said analyte comprises a surface glycoprotein of an influenza virus.

7. The system of claim 6, wherein said surface glycoprotein comprises a hemagglutinin.

8. The system of claim 7, wherein said hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16.

9. The system for claim 7, wherein said hemagglutinin is H5.

10. The system of claim 6, wherein said surface glycoprotein comprises a neuraminidase.

11. The system of claim 10, wherein said neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5.

12. The system of claim 10, wherein said neuraminidase is N1.

13. The system of claim 1, wherein said analyte is an antibody specific for a surface glycoprotein of an influenza virus.

14. The system of claim 1, wherein said subject is a human.

15. The system of claim 1, wherein said subject is an animal.

16. The system of claim 1, wherein said animal is poultry.

30. A method for detecting an analyte indicative of an influenza viral infection in a bodily fluid of a subject, comprising:

a) providing a system of claim 1;

b) allowing a sample of bodily fluid to react with the reactants contained within said assay assembly to yield a detectable signal indicative of the presence of said analyte; and

c) detecting said detectable signal.

17. A system for detecting a plurality of analytes, at least two of which are indicative of an influenza viral infection in a bodily fluid from a subject, comprising:

a) a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows a sample of bodily fluid suspected to contain said plurality of analytes to react with reactants contained within said assay assembly to yield one or more detectable signals indicative of the presence of said at least two analytes;

b) a reader assembly comprising a detection assembly for detecting said one or more detectable signals; and

c) a communication assembly for transmitting said detected signal to an external device.

18. The system of claim 17, wherein said sample of bodily fluid suspected to contain said plurality of analytes reacts with reactants contained within said assay assembly based on a protocol transmitted from said external device.

19. The system of claim 17, wherein said plurality of analytes are indicative of an influenza type A viral infection.

20. The system of claim 17, wherein said plurality of analytes are indicative of an influenza type B viral infection.

21. The system of claim 17, wherein said plurality of analytes are indicative of an influenza type C viral infection.

22. The system of claim 17, wherein said plurality of analytes comprises a plurality of surface glycoproteins of an influenza virus.

23. The system of claim 22, wherein said plurality of surface glycoproteins comprises a hemagglutinin and a neuraminidase.

24. The system of claim 23, wherein said hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and said neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5.

25. The system of claim 23, wherein said hemagglutinin is H5 and said neuraminidase is N1.

26. The system of claim 17, wherein said plurality of analytes comprises a plurality of antibodies specific for surface glycoproteins of an influenza virus.

27. The system of claim 17, wherein said subject is a human.

28. The system of claim 17, wherein said subject is an animal.

29. The system of claim 28, wherein said animal is poultry.

31. A method of detecting an analyte indicative of an influenza viral infection in a bodily fluid from a subject, comprising:

a) providing a fluidic device comprising at least one sample collection unit, an immunoassay assembly containing immunoassay reagents, a plurality of channels in fluid communication with said sample collection unit and/or said immunoassay assembly;

b) actuating said fluidic device and directing said immunoassay reagents within said fluidic device;

c) allowing a sample of bodily fluid suspected to contain said analyte to react with said immunoassay reagents contained within said assay immunoassay assembly to yield a detectable signal indicative of the presence of said analyte indicative of an influenza viral infection in said sample; and

d) detecting said detectable signal generated from said analyte collected in said sample of bodily fluid.

32. The method of claim 31, wherein said sample of bodily fluid is less than about 500 microliters.

33. The system of claim 31, wherein said analyte is indicative of an influenza type A viral infection.

34. The system of claim 31, wherein said analyte is indicative of an influenza type B viral infection.

35. The system of claim 31, wherein said analyte is indicative of an influenza type C viral infection.

36. The system of claim 31, wherein said analyte comprises a surface glycoprotein of an influenza virus.

37. The system of claim 36, wherein said surface glycoprotein comprises a hemagglutinin.

38. The system of claim 37, wherein said hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H1, H12, H13, H14, H15, and H16.

39. The system for claim 37, wherein said hemagglutinin is H5.

40. The system of claim 36, wherein said surface glycoprotein comprises a neuraminidase.

41. The system of claim 40, wherein said neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5.

42. The system of claim 40, wherein said neuraminidase is N1.

43. The system of claim 31, wherein said analyte is an antibody to a surface glycoprotein of an influenza virus.

44. The system of claim 31, wherein said subject is a human.

45. The system of claim 31, wherein said subject is an animal.

46. The system of claim 45, wherein said animal is poultry.

47. A method of detecting a plurality of analytes, at least two of which are indicative of an influenza viral infection in a bodily fluid from a subject, comprising:

a) providing a fluidic device comprising at least one sample collection unit, an immunoassay assembly containing immunoassay reagents, a plurality of channels in fluid communication with said sample collection unit and/or said immunoassay assembly;

b) actuating said fluidic device and directing said immunoassay reagents within said fluidic device;

c) allowing a sample of bodily fluid suspected to contain said plurality of analytes to react with said immunoassay reagents contained within said assay immunoassay assembly to yield one or more detectable signals indicative of the presence of said at least two analytes in said sample; and

d) detecting said one or more detectable signals generated from said plurality of analytes collected in said sample of bodily fluid.

48. The method of claim 47, wherein said sample of bodily fluid is less than about 500 microliters.

49. The method of claim 47, wherein said plurality of analytes are indicative of an influenza type A viral infection.

50. The method of claim 47, wherein said plurality of analytes are indicative of an influenza type B viral infection.

51. The method of claim 47, wherein said plurality of analytes are indicative of an influenza type C viral infection.

52. The method of claim 47, wherein said at least two analytes form a complex.

53. The method of claim 52, wherein said complex comprises H5N1.

54. The method of claim 47, wherein at least one of said analytes is a surface glycoprotein of an influenza virus and at least one of said analytes is a human antibody to said surface glycoprotein.

55. The method of claim 47, wherein at least one of said analytes is a surface glycoprotein of an influenza virus and at least one of said analytes is a biomarker in the sample of bodily fluid indicative of the stress imposed on the human body by the viral infection.

56. The method of claim 47, wherein said plurality of analytes comprises a plurality of surface glycoproteins of an influenza virus.

57. The method of claim 56, wherein said plurality of surface glycoproteins comprises a hemagglutinin and a neuraminidase.

58. The method of claim 57, wherein said hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and said neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5.

59. The method of claim 57, wherein said hemagglutinin is H5 and said neuraminidase is N1.

60. The method of claims 47, wherein said plurality of analytes comprises a plurality of antibodies to surface glycoproteins of an influenza virus.

61. The method of claim 47, wherein said subject is a human.

62. The method of claim 47, wherein said subject is an animal.

63. The method of claim 62, wherein said animal is poultry.

64. A fluidic device for detecting a type of influenza viral infection, comprising:

a cartridge comprising a plurality of reactants, at least two of which are reactive with different analytes present in a bodily fluid from a subject, wherein said different analytes are indicative of the type of influenza infection.

65. The fluidic device of claim 64, where each of the at least two reactants binds to a different surface glycoprotein of an influenza virus.

66. The fluidic device of claim 65, wherein said different surface glycoprotein comprises a member selected from the group consisting of hemagglutinin and neuraminidase.

67. The fluidic device of claim 65, wherein said different surface glycoprotein comprises a member selected from the group consisting of hemagglutinin 1, hemagglutinin 2, hemagglutinin 3, hemagglutinin 4, hemagglutinin 5, hemagglutinin 6, hemagglutinin 7, hemagglutinin 8, hemagglutinin 9, hemagglutinin 10, hemagglutinin 11, hemagglutinin 12, hemagglutinin 13, hemagglutinin 14, hemagglutinin 15, hemagglutinin 16, neuraminidase 1, neuraminidase 2, neuraminidase 3, neuraminidase 4, and neuraminidase 5.

68. The fluidic device of claim 64, wherein one of the at least two reactants binds to H5, and wherein one of the at least two reactants binds to N1.

69. The fluidic device of claim 64, where said cartridge further comprises a sample collection unit and an assay assembly that comprises said reactants.

70. The fluidic device of claim 69, where said assay assembly comprises an immunoassay assembly.