DIAGNOSTIC DEVICES AND RELATED METHODS

• US 20100267049A1
• Filed: 04/14/2010
• Published: 10/21/2010
• Est. Priority Date: 04/15/2009
• Status: Abandoned Application

• Current Assignee: Relia Diagnostic Systems Inc.
• Original Assignee: Relia Diagnostic Systems Inc.
• Inventors: Izmailov, Alexandre, RUTTER, William J., Sierra, George Harold, Liu, Hongjian, Ye, Zhihai, Zhang, Jimmy Z., Warner, Brian David
• Application Number:
  US12/760,518
• Publication Number:
  US 20100267049A1
• Time in Patent Office: Days
• US Class Current: 435/7.100
• CPC Class Codes: G01N 2021/6419 Excitation at two or more wavelengths
• CPC Class Codes: G01N 2021/6421 Measuring at two or more wavelengths
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/658 enhancement Raman, e.g. surface plasmons
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 21/78 producing a change of colour
• 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 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

Devices, systems, and methods for detecting the presence of one or more analytes in a sample are described. In some variations, a test strip may be used to detect and/or analyze one or more analytes in a sample. In certain variations, a test strip configured to receive a sample for detection of an analyte therein may comprise a substrate and a coating on a portion of the substrate, the coating comprising a combination of a first analyte capture agent configured to bind to a first analyte and a second analyte capture agent configured to bind to a second analyte that is different from the first analyte.

Claims

1. A test strip configured to receive a sample for detection of an analyte therein, the test strip comprising:

a substrate; and

a coating on a portion of the substrate, the coating comprising a combination of a first analyte capture agent configured to bind to a first analyte and a second analyte capture agent configured to bind to a second analyte that is different from the first analyte.

2. The test strip of claim 1, wherein the coating comprises a mixture of the first and second analyte capture agents.

3. The test strip of claim 1, wherein the second analyte is a control analyte.

4. The test strip of claim 1, further comprising an analyte binding agent and a control analyte that are each labeled with detectable markers.

5. The test strip of claim 4, wherein the analyte binding agent is labeled with a first fluorophore.

6. The test strip of claim 5, wherein the control analyte is labeled with a second fluorophore that is different from the first fluorophore.

7. The test strip of claim 1, wherein the substrate comprises nitrocellulose.

8. The test strip of claim 1, wherein the coating forms a first band on the substrate.

9. The test strip of claim 8, further comprising a second band configured for addition of the sample thereto.

10. The test strip of claim 9, wherein the first band is from about 3 millimeters to about 5 millimeters from the second band.

11. The test strip of claim 1, wherein the first analyte capture agent is selected from the group consisting of antibodies, engineered proteins, peptides, haptens, lysates containing heterogeneous mixtures of antigens having analyte binding sites, ligands, and receptors.

12. The test strip of claim 11, wherein the second analyte capture agent is selected from the group consisting of antibodies, engineered proteins, peptides, haptens, lysates containing heterogeneous mixtures of antigens having analyte binding sites, ligands, and receptors.

13. A method for detecting at least one analyte in a sample comprising:

applying the sample to a portion of a test strip comprising a coating comprising a first analyte capture agent configured to bind to a first analyte and a second analyte capture agent configured to bind to a second analyte that is different from the first analyte; and

applying light to the test strip,

wherein the application of light to the test strip provides an indication of whether the first analyte is present in the sample.

14. The method of claim 13, wherein the second analyte is a control analyte.

15. The method of claim 13, further comprising measuring the concentration of the first analyte in the sample.

16. The method of claim 15, wherein applying light to the test strip comprises applying light from first and second light sources to the test strip.

17. The method of claim 16, wherein at least one of the first and second light sources comprises a laser.

18. The method of claim 17, wherein the first light source comprises a first laser and the second light source comprises a second laser that is different from the first laser.

19. The method of claim 16, wherein the test strip further comprises an analyte binding agent labeled with a first fluorophore that fluoresces upon exposure to light from the first light source.

20. The method of claim 19, wherein the test strip further comprises a control analyte labeled with a second fluorophore that fluoresces upon exposure to light from the second light source.

21. The method of claim 20, wherein measuring the concentration of the first analyte in the sample comprises comparing the intensity of the fluorescence of the first fluorophore to the intensity of the fluorescence of the second fluorophore.

22. The method of claim 15, wherein the second analyte is a control analyte, and measuring the concentration of the first analyte in the sample comprises using a processor, memory resources, and software to evaluate the amount of the first analyte capture agent that is bound to the first analyte relative to the amount of the second analyte capture agent that is bound to the second analyte.

23. The method of claim 22, wherein the processor, memory resources, and software analyze the test strip at least about one second after the sample has been applied to the portion of the test strip.

24. The method of claim 13, wherein the sample comprises blood, and wherein the method further comprises passing the sample through a filter before applying the sample to the portion of the test strip.

25. The method of claim 13, wherein the first analyte capture agent is selected from the group consisting of antibodies, engineered proteins, peptides, haptens, lysates containing heterogeneous mixtures of antigens having analyte binding sites, ligands, and receptors.

26. The method of claim 25, wherein the second analyte capture agent is selected from the group consisting of antibodies, engineered proteins, peptides, haptens, lysates containing heterogeneous mixtures of antigens having analyte binding sites, ligands, and receptors.

27. A method of making a test strip configured to receive a sample for detection of an analyte therein, the method comprising:

combining a first analyte capture agent with a second analyte capture agent to form a coating material, wherein the first analyte capture agent is configured to bind to a first analyte and the second analyte capture agent is configured to bind to a second analyte that is different from the first analyte; and

applying the coating material to a portion of a substrate to form a coating on the substrate.

28. The method of claim 27, wherein the second analyte is a control analyte.

29. A point-of-care system for detecting an analyte in a sample, the point-of-care system comprising:

an apparatus comprising a first laser, a second laser that is different from the first laser, and a housing comprising a receptacle; and

a test strip configured to fit within the receptacle,

wherein the first laser is configured to apply a first beam to a location on the test strip when the test strip is positioned in the receptacle, and the second laser is configured to apply a second beam to the same location on the test strip when the test strip is positioned in the receptacle.

30. The system of claim 29, wherein the apparatus further comprises at least one mirror configured to direct application of at least one of the first and second beams to the test strip.

31. The system of claim 29, wherein the apparatus further comprises an objective lens configured to receive light emitted from the test strip.

32. The system of claim 31, wherein the apparatus further comprises a first detector configured to detect light emitted from the test strip and received through the objective lens.

33. The system of claim 29, wherein the test strip comprises a substrate and a coating on a portion of the substrate, the coating comprising a first analyte capture agent configured to bind to a first analyte and a second analyte capture agent configured to bind to a second analyte that is different from the first analyte.

34. The system of claim 33, wherein the test strip further comprises an analyte binding agent and a control analyte, and wherein the analyte binding agent and the control analyte are labeled with detectable markers.

35. The system of claim 34, wherein the analyte binding agent is labeled with a first fluorophore and the control analyte is labeled with a second fluorophore.

36. The system of claim 35, wherein the first laser emits light at a wavelength within the excitation spectrum of the first fluorophore.

37. The system of claim 36, wherein the second laser emits light at a wavelength within the excitation spectrum of the second fluorophore.

38. The system of claim 35, wherein the apparatus further comprises an objective lens configured to receive light emitted from the location of the receptacle.

39. The system of claim 38, wherein the apparatus further comprises a first detector configured to detect light emitted from the location of the receptacle and received through the objective lens.

40. The system of claim 39, wherein the first detector is configured to detect fluorescence from the first fluorophore.

41. The system of claim 40, wherein the apparatus further comprises a second detector configured to detect fluorescence from the second fluorophore.

42. The system of claim 41, wherein the apparatus further comprises a filter configured to separate fluorescence from the first fluorophore from fluorescence from the second fluorophore.

43. The system of claim 42, wherein the filter comprises a dichroic filter.

44. The system of claim 29, wherein the first laser emits light at a wavelength of about 300 nm to about 800 nm.

45. The system of claim 44, wherein the second laser emits light at a wavelength of about 300 nm to about 800 nm.

46. The system of claim 45, wherein the first laser emits light at a different wavelength from the second laser.

47. The system of claim 29, wherein the first laser comprises a laser emitting in the red region of spectrum.

48. The system of claim 47, wherein the second laser comprises an infrared laser.

49. The system of claim 29, wherein the second laser comprises an infrared laser.

50. The system of claim 29, wherein at least one of the first and second lasers is a fiber-coupled laser.

51. The system of claim 29, wherein the apparatus further comprises a photodiode.

52. The system of claim 29, wherein the apparatus is configured to measure the concentration of the first analyte to an analytical sensitivity of about 3 pg/mL.

53. The system of claim 29, wherein the apparatus is configured to measure the concentration of the first analyte to an analytical sensitivity of at least 3 pg/mL with a coefficient of variation of less than 5%.

54. The system of claim 29, wherein the system is configured to detect a plurality of analytes in a sample.

55. The system of claim 54, wherein the system is configured to detect from ten to twenty analytes on the test strip.

56. A method for detecting at least one analyte in a sample comprising:

applying the sample to a test strip;

applying a first beam from a first laser of a point-of-care diagnostic system to a location on the test strip; and

applying a second beam from a second laser of the point-of-care diagnostic system to the same location on the test strip,

wherein the application of the first and second beams to the location on the test strip provides an indication of whether the at least one analyte is present in the sample.

57. The method of claim 56, wherein the first and second beams are applied to the test strip simultaneously.

58. A method comprising:

adding a sample obtained from a subject to a point-of-care diagnostic system configured to obtain data from the sample regarding the presence or absence of one or more analytes therein, and to transmit the data in real time to a remote location where the data may be evaluated and/or incorporated into a medical record of the subject.

59. The method of claim 58, wherein the remote location is at least about 20 feet from the point-of-care diagnostic system

60. The method of claim 58, wherein the subject adds the sample to the point-of-care diagnostic system.

61. The method of claim 60, wherein the sample is added to the point-of-care diagnostic system in a non-clinical setting.

62. The method of claim 58, wherein the point-of-care diagnostic system is configured for operation by an operator without medical training.

63. The method claim 58, wherein the point-of-care diagnostic system is configured to transmit the data to the remote location telephonically.

64. The method of claim 58, wherein the point-of-care diagnostic system is configured to transmit the data to the remote location via the Internet.

65. The method of claim 58, wherein the point-of-care diagnostic system is configured to transmit the data to the remote location via an intranet.

66. The method of claim 58, wherein the point-of-care diagnostic system comprises a test strip, and wherein adding the sample to the point-of-care diagnostic system comprises applying the sample to the test strip.

67. The method of claim 66, wherein the test strip comprises a substrate and a coating on a portion of the substrate, the coating comprising a combination of a first analyte capture agent configured to bind to a first analyte and a second analyte capture agent configured to bind to a second analyte that is different from the first analyte.

68. The method of claim 67, wherein the data includes the concentration of at least one of the first and second analytes.

69. The method of claim 58, wherein the point-of-care diagnostic system comprises an apparatus comprising a first laser, a second laser, and a housing comprising a receptacle, and a test strip configured to fit within the receptacle.

70. The method of claim 69, wherein adding the sample to the point-of-care diagnostic system comprises applying the sample to the test strip when the test strip is positioned in the receptacle.

71. The method of claim 70, further comprising applying a first beam from the first laser to the test strip, and applying a second beam from the second laser the test strip.

72. A method comprising:

adding a sample obtained from a subject to a point-of-care diagnostic system,

wherein the point-of-care diagnostic system is configured for operation by an operator in a remote location.

73. The method of claim 72, wherein the remote location is at least about 20 feet from the point-of-care diagnostic system

74. The method of claim 72, wherein the point-of-care diagnostic system is configured to transmit data obtained from the sample to the remote location in real time.

75. The method of claim 72, wherein the subject adds the sample to the point-of-care diagnostic system.

76. The method of claim 75, wherein the sample is added to the point-of-care diagnostic system in a non-clinical setting.

77. The method of claim 72, wherein the point-of-care diagnostic system is configured for telephonic operation.

78. The method of claim 72, wherein the point-of-care diagnostic system is configured for operation via the Internet.

79. The method of claim 72, wherein the point-of-care diagnostic system is configured for operation via an intranet.

80. The method of claim 72, wherein the operator is a medical professional.

81. The method of claim 72, wherein the point-of-care diagnostic system is configured to be automatically refilled or replenished.

82. The method of claim 72, wherein the point-of-care diagnostic system comprises a test strip, and wherein adding the sample to the point-of-care diagnostic system comprises applying the sample to the test strip.

83. The method of claim 82, wherein the test strip comprises a substrate and a coating on a portion of the substrate, the coating comprising a combination of a first analyte capture agent configured to bind to a first analyte and a second analyte capture agent configured to bind to a second analyte that is different from the first analyte.

84. The method of claim 83, wherein the data includes the concentration of at least one of the first and second analytes.

85. The method of claim 72, wherein the point-of-care diagnostic system comprises an apparatus comprising a first laser, a second laser, and a housing comprising a receptacle, and a test strip configured to fit within the receptacle.

86. The method of claim 85, wherein adding the sample to the point-of-care diagnostic system comprises applying the sample to the test strip when the test strip is positioned in the receptacle.

87. The method of claim 86, further comprising applying a first beam from the first laser to the test strip, and applying a second beam from the second laser the test strip.