Integration of fluids and reagents into self-contained cartridges containing sensor elements

• US 20060257993A1
• Filed: 12/22/2004
• Published: 11/16/2006
• Est. Priority Date: 02/27/2004
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Floriano, Pierre N., Neikirk, Dean, Ballard, Karri L., McDevitt, John T., Christodoulides, Nick, Anslyn, Eric, Shear, Jason
• Granted Patent: US 8,105,849 B2
• Time in Patent Office: Days
• US Class Current: 435/287.200
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• 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 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• 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: Y10S 436/809 Multifield plates or multicontainer arrays

Abstract

Described herein is an analyte detection device and method related to a portable instrument suitable for point-of-care analyses. In some embodiments, a portable instrument may include a disposable cartridge, an optical detector, a sample collection device and/or sample reservoir, reagent delivery systems, fluid delivery systems, one or more channels, and/or waste reservoirs. Use of a portable instrument may reduce the hazard to an operator by reducing an operator'"'"'s contact with a sample for analysis. The device is capable of obtaining diagnostic information using cellular- and/or particle-based analyses and may be used in conjunction with membrane- and/or particle-based analysis cartridges. Analytes, including proteins and cells and/or microbes may be detected using the membrane and/or particle based analysis system.

Claims

1. A system for detecting an analyte in a sample comprising:

a sample collection device, wherein the sample collection device is configured to obtain the sample;

a cartridge, wherein the cartridge comprises;

one or more detection systems disposed within the cartridge, wherein at least one of the detection systems is configured to interact with at least a portion of the sample to allow detection of the analyte;

a sample reservoir, wherein the sample collection device is configured to deliver the sample to the sample reservoir; and

wherein the sample is substantially contained in the cartridge during use; and

an optical platform, wherein the optical platform is configured to detect a signal produced by the interaction of the analyte with at least one of the detection systems during use.

4. The system of claim 1, wherein at least one of the detection systems comprises a membrane-based detection system, and wherein the membrane-based detection system comprises a membrane coupled to a body.

6. The system of claim 4, further comprising a membrane support in contact with the membrane, wherein the membrane support is configured to maintain the membrane in a substantially planar orientation during use.

10. The system of claim 4, further comprising a top member positioned at a spaced distance above the membrane such that a first cavity is formed between the top member and the membrane, and wherein the top member covers at least a portion of the membrane.

26. The system of claim 1, wherein at least one of the detection systems comprises a particle-based detection system, and wherein the particle-based detection system comprises:

a supporting member comprising one or more cavities formed within the supporting member; and

one or more particles positioned in at least one of the cavities.

29. The system of claim 26, wherein at least one of the cavities is configured to allow fluid to pass through the supporting member during use, and wherein a width of a bottom portion of at least one of the cavities is less than a width of a top portion of the cavity, and wherein the width of the bottom portion of the cavity is less than a width of the particle in the cavity.

33. The system of claim 26, wherein the particle-based detection system further comprises a cover layer positioned over at least one of the cavities, wherein the cover layer is configured to inhibit dislodgment of at least one of the particles during use, and wherein the cover layer is positioned such that one or more channels are formed between an upper surface of the supporting member and the cover layer such that at least a portion of the sample passes through at least one of the channels during use.

41. The system of claim 26, wherein at least one of the particles comprises a receptor molecule coupled to a polymeric resin.

43. The system of claim 26, wherein at least one of the particles comprises a receptor molecule coupled to a polymeric resin, and wherein the particle further comprises a first indicator and a second indicator, the first and second indicators being coupled to the receptor, and wherein interaction of the receptor with the analyte causes the first and second indicators to produce the signal.

44. The system of claim 26, wherein at least one of the particles comprises a receptor molecule coupled to a polymeric resin, and wherein the particle further comprises an indicator, wherein the indicator is associated with the receptor such that in the presence of the analyte, the indicator is displaced from the receptor to produce the signal.

48. The system of claim 26, wherein at least one of the particles comprises a polymeric resin, and a biopolymer coupled to the polymeric resin, and wherein the biopolymer undergoes a chemical reaction in the presence of the analyte to produce the signal.

51. The system of claim 26, wherein at least one of the particles is configured to entrap microbes.

53. The system of claim 1, wherein the one or more detection systems comprise two or more dectection systems, and wherein the two or more detection systems comprise one or more particle-based detection systems and one or more membrane-based detection systems.

54. The system of claim 53, wherein at least one of the particle-based detection systems is coupled to at least one of the membrane-based detection systems via one or more channels.

55. The system of claim 1, wherein the sample collection device comprises a needle.

56. The system of claim 1, wherein the sample collection device comprises a pressurized unit.

57. The system of claim 1, wherein the sample collection device comprises a capillary tube.

58. The system of claim 1, wherein the sample collection device is configured to be coupled to the cartridge.

61. The system of claim 1, wherein the sample collection device is configured to collect a predetermined quantity of sample during use.

62. The system of claim 1, wherein the sample reservoir comprises a sample pick-up pad.

71. The system of claim 1, further comprising one or more filters, wherein the system is configured such that at least a portion of the sample passes through at least one of the filters before interacting with at least one of the detection systems.

72. The system of claim 1, further comprising a vacuum chamber coupled to a conduit and the cartridge, and wherein the vacuum chamber is configured to provide a pulling force on the sample in the cartridge.

73. The system of claim 1, further comprising a waste reservoir.

78. The system of claim 1, wherein the optical platform comprises a light emitting diode.

79. The system of claim 1, wherein the optical platform comprises a red light source, a green light source, and a blue light source.

80. The system of claim 1, wherein the optical platform comprises a detector configured to detect independently the absorbance of red light, wherein the detector is configured to detect independently the absorbance of green light, and wherein the detector is configured to detect independently the absorbance of blue light.

81. The system of claim 1, wherein the optical platform comprises a white light source.

82. The system of claim 1, wherein the optical platform comprises a detector, and wherein the detector comprises a charge-coupled device.

89. The system of claim 1, wherein the sample comprises blood.

90. The system of claim 1, further comprising a reagent reservoir, wherein the system is configured such that at least a portion of the sample passes through a reagent reservoir before interacting with at least one of the detection systems.

135. The system of claim 1, wherein the cartridge further comprises a waste reservoir.

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