Rapid diagnostic assay

• US 20060094028A1
• Filed: 11/04/2004
• Published: 05/04/2006
• Est. Priority Date: 11/04/2004
• Status: Abandoned Application

• Current Assignee: Welch Allyn Incorporated
• Original Assignee: Welch Allyn Incorporated
• Inventors: Newman, Richard W., Danna, Dominick, Krauter, Allan I., Kugler, Andrew Jay, Scinta, Wendy Marie
• Application Number:
  US10/981,369
• Publication Number:
  US 20060094028A1
• Time in Patent Office: Days
• US Class Current: 435/6.11
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• 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 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/565 Seals in general F16L
• CPC Class Codes: G01N 2035/00158 Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 33/56944 Streptococcus
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: G01N 33/56994 Herpetoviridae, e.g. cytomegalovirus, Epstein-Barr virus

Abstract

Disclosed is a rapid and easy to use diagnostic tool that a point-of-care practitioner can use to specifically identify the cause of a disease, such as the upper respiratory infection (URI) pharyngitis. Such a disease has multiple potential causative pathogens and has a number of combined clinical manifestations. The diagnostic tool is rapid in order to provide the busy point-of-care practitioner with an assay result within a time that does not affect patient flow. The time usually available to such a practitioner is optimally less than 10 minutes, so that an assay that detects multiple pathogens rapidly is regarded as one that does so in less than 10 minutes. The diagnostic tool can be operated with minimal training and within the confines of said practitioner'"'"'s environment. The diagnostic tool has specificity and sensitivity above those of the prior art devices. The tool is self-contained, which thereby helps to control the spread of infection and eases the burden of disposal of used equipment. The tool includes a diagnostic card configured to enable a plurality of nucleic acid diagnostic assays for rapidly detecting the presence or absence of multiple pathogens at the point-of-care. The tool includes a device that interacts with the card and that contains assay analysis means.

Claims

1. An apparatus comprising:

a diagnostic card configured to enable a plurality of nucleic acid diagnostic assays for rapidly detecting the presence or absence of multiple pathogens at the point-of-care.

2. The apparatus of claim 1 wherein said multiple pathogens share a common clinical manifestation.

3. The apparatus of claim 1 wherein said multiple pathogens include at least two pathogens selected from the group consisting of viruses, bacteria, fungi, and parasites.

4. The apparatus of claim 1 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite and at least a second pathogen selected from the group consisting of a virus, a bacteria, a fungi, and a parasite, wherein said first pathogen and said second pathogen are different.

5. The apparatus of claim 1 wherein said assays comprise DNA assays.

6. The apparatus of claim 1 wherein said assays comprise RNA assays.

7. The apparatus of claim 1 wherein said nucleic acid assays include an amplification phase.

8. The apparatus of claim 7 wherein said amplification phase comprises polymerase chain reaction.

9. The apparatus of claim 1 wherein said nucleic acid assays include a positive control and a negative control for each of said multiple pathogens.

10. The apparatus of claim 2 wherein said common clinical manifestation comprises at least one of sore throat, swollen glands, and fever.

11. The apparatus of claim 10 wherein said assays are designed to detect the presence of at least two pathogens selected from the group consisting of Streptococcus Pyogenes, Influenza A, Influenza B, and Epstein-Barr Virus.

12. The apparatus of claim 1 further comprising a sample port that is sealed after a sample is introduced to said diagnostic cartridge.

13. The apparatus of claim 1 wherein said card utilizes a single sample to detect the presence or absence of any of said pathogens.

14. The apparatus of claim 13 wherein said single sample is introduced into said card by a sample collection device.

15. The apparatus of claim 1 wherein at least one reagent for said assays is contained on board said card.

16. The apparatus of claim 15 wherein said at least one reagent is selected from the group consisting of a lysis fluid, an elution fluid, a rehydrating fluid, pumping fluid, drying reagents, and polymerase chain reaction reagents.

17. The apparatus of claim 1 further comprising a chamber for conducting polymerase chain reaction.

18. The apparatus of claim 17 wherein said chamber is configured to allow for rapid thermal cycling.

19. The apparatus of claim 1 further comprising an on-board pump.

20. The apparatus of claim 19 wherein said pump is a peristaltic pump.

21. The apparatus of claim 1 wherein said card includes means for storing information.

22. The apparatus of claim 21 wherein said information comprises data incident to sample collection and operation of the system.

23. A medical diagnostic system comprising:

a diagnostic card configured to enable a plurality of nucleic acid diagnostic assays for rapidly detecting the presence or absence of multiple pathogens at the point-of-care; and

a device that interacts with said card, said device including assay analyses means.

24. The system of claim 23 wherein said multiple pathogens share a common clinical manifestation.

25. The system of claim 23 wherein said multiple pathogens include at least two pathogens selected from the group consisting of viruses, bacteria, fungi, and parasites.

26. The system of claim 23 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacteria, a fungi, and a parasite and at least a second pathogens selected from the group consisting of a virus, a bacterium, a fungus, and a parasite, wherein said first pathogen and said second pathogen are different.

27. The system of claim 23 wherein said assays comprise DNA assays.

28. The system of claim 23 wherein said assays comprise RNA assays.

29. The system of claim 23 wherein said nucleic acid assays include an amplification phase.

30. The system of claim 29 wherein said amplification phase comprises polymerase chain reaction.

31. The system of claim 23 wherein said nucleic acid assays include a positive control and a negative control for each of said multiple pathogens.

32. The system of claim 24 wherein said common clinical manifestation comprises at least one of sore throat, swollen glands, and fever.

33. The system of claim 32 wherein said assays are designed to detect the presence of at least two of the group consisting of Streptococcus Pyogenes, Influenza A, Influenza B, or Epstein-Barr Virus.

34. The system of claim 23 further comprising a sample port that is sealed after a sample is introduced to said diagnostic cartridge.

35. The system of claim 23 wherein said card utilizes a single sample to detect the presence or absence of any of said pathogens.

36. The system of claim 35 wherein said single sample is introduced into said card by a sample collection device.

37. The system of claim 23 wherein at least one reagent for said nucleic acid assays is contained on board said card.

38. The system of claim 37 wherein said at least one reagent is selected from the group consisting of a lysis fluid, an elution fluid, a rehydrating fluid, pumping fluid, drying reagent, and polymerase chain reaction reagents.

39. The system of claim 23 further comprising a chamber for conducting polymerase chain reaction.

40. The system of claim 39 wherein said chamber is configured to allow for rapid thermal cycling.

41. The system of claim 23 further comprising a pump on board said device.

42. The system of claim 41 wherein said pump is a peristaltic pump.

43. The system of claim 42 wherein said device comprises a driver for said peristaltic pump.

44. The system of claim 23 wherein said device comprises a fluorometer.

45. The system of claim 23 wherein said device comprises a means for providing thermal cycling to said card.

46. The system of claim 23 wherein said device comprises a means for determining information about said card.

47. The system of claim 46 wherein said means for determining information comprises a bar code reader.

48. The system of claim 46 wherein said card comprises a bar code.

49. The system of claim 48 wherein said information includes data incident to sample collection and operation of the system.

50. The system of claim 23 wherein said device comprises a communication means.

51. The system of claim 50 wherein said communication means comprises a modem.

52. The system of claim 23 wherein by actuating said device after interaction with said card, said rapid detection is automatically carried out.

53. A method of diagnosing the underlying cause of a common clinical manifestation, said method comprising:

providing a diagnostic card configured to enable a plurality of nucleic acid diagnostic assays for rapidly detecting multiple pathogens at the point-of-care;

introducing a single sample into said card;

interacting said card with a device having analyzing means wherein said device determines the results of said diagnostic assays.

54. The method of claim 53 wherein said multiple pathogens share a common clinical manifestation.

55. The method of claim 53 wherein said multiple pathogens include at least two pathogens selected from the group consisting of viruses, bacteria, fungi, and parasites.

56. The method of claim 53 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacteria, a fungi, and a parasite and at least a second pathogens selected from the group consisting of a virus, a bacterium, a fungus, and a parasite, wherein said first pathogen and said second pathogen are different.

57. The method of claim 53 wherein said assays comprise DNA assays.

58. The method of claim 53 wherein said assays comprise RNA assays.

59. The method of claim 53 wherein said nucleic acid assays include an amplification phase.

60. The method of claim 59 wherein said amplification phase comprises polymerase chain reaction.

61. The method of claim 53 wherein said nucleic acid assays include a positive control and a negative control for each of said multiple pathogens.

62. The method of claim 54 wherein said common clinical manifestation comprises at least one of a sore throat, swollen lymph nodes, and fever.

63. The method of claim 62 wherein said assays are designed to detect the presence of at least two of the group consisting of Streptococcus Pyogenes, influenza A, influenza B, and Epstein-Barr Virus.

64. The method of claim 53 further comprising a sample port that is sealed after a sample is introduced to said diagnostic card.

65. The method of claim 53 wherein said card utilizes a single sample to detect the presence or absence of any of said pathogens.

66. The method of claim 65 wherein said single sample is introduced into said card by a sample collection device.

67. The method of claim 53 wherein at least one reagent for said nucleic acid assay is contained on board said card.

68. The method of claim 67 wherein said at least one reagent is selected from the group consisting of a lysis fluid, an elution fluid, a rehydrating fluid, air, and polymerase chain reaction reagents.

69. The method of claim 53 further comprising a chamber for conducting polymerase chain reaction.

70. The method of claim 69 wherein said chamber is configured to allow for rapid thermal cycling.

71. The method of claim 53 further comprising a pump on board said device.

72. The method of claim 71 wherein said pump is a peristaltic pump.

73. The method of claim 71 wherein said device comprises a driver for said peristaltic pump.

74. The method of claim 53 wherein said device comprises a fluorometer.

75. The method of claim 53 wherein said device comprises a means for providing thermocyling to said card.

76. The method of claim 53 wherein said device comprises a means for determining information about said card.

77. The method of claim 76 wherein said means for determining information comprises a bar code reader.

78. The method of claim 77 wherein said card comprises a bar code.

79. The method of claim 78 wherein said information includes data incident to sample collection and operation of the system.

80. The method of claim 53 wherein said device comprises a communication means.

81. The method of claim 80 wherein said communication means comprises a modem.

82. The method of claim 53 wherein by actuating said device after interaction with said card, said rapid detection is automatically carried out.