Apparatus and method for process monitoring

• US 20040265175A1
• Filed: 05/14/2004
• Published: 12/30/2004
• Est. Priority Date: 05/14/2003
• Status: Active Grant

• Current Assignee: Source Scientific
• Original Assignee: FasTraq, Inc. (Quantech Ltd.)
• Inventors: Witty, Thomas R., Case, Robert
• Granted Patent: US 7,217,393 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/117497 with a continuously flowing sample or carrier stream
• CPC Class Codes: Y10T 436/118339 with formation of a segmented stream

Abstract

An apparatus is provided for testing fluid samples includes a sensor, which can be light source, directed to a flow cell and a photo sensor for detecting a light beam reflected from the flow cell. The photo sensor monitors the fluid in the flow cell by sensing the reflected light beam from the flow cell, thereby monitoring the test

Claims

1. An apparatus for testing fluid samples, comprising:

a flow cell support;

a flow cell adapted to be positioned in the flow cell support, the flow cell including a measurement chamber;

a monitor device that monitors and produces a signal indicative of an introduction and an exit of at least one of a sample or a reagent to and from a measurement chamber; and

logic resources that receive the signal and performs a comparison of a timing of the introduction and the exit of the sample to and from measurement chamber to produces a confirmation of a point in time of a valid reaction of the sample in measurement chamber;

an energy source that produces an output of energy that interacts with measurement chamber; and

a sensor positioned to receive an output from the flow cell.

2. The apparatus of claim 1, wherein the monitoring device includes the energy source.

3. The apparatus of claim 1, wherein the monitoring device includes the sensor.

4. The apparatus of claim 1, wherein the monitoring device includes the energy source and the sensor.

5. The system of claim 1, wherein the monitoring device directly monitors a progress of events inside measurement chamber.

6. The system of claim 1, wherein the output is light intensity.

7. The system of claim 1, wherein the output is a measurement of wavelength

8. The system of claim 1, wherein the output is a measurement of electric capacitance.

9. The system of claim 1, wherein the output is a measurement of conductivity.

10. The apparatus of claim 1, wherein the monitor provides an indication of a response of the sample to a mechanical change of the apparatus

11. The apparatus of claim 10, wherein the mechanical change is selected from at least one of, movement of a pump to create a flow of sample or reagent, movement of a reaction area in measurement chamber, movement of measurement chamber, and a mechanical response relative to a secondary reaction in measurement chamber.

12. The apparatus of claim 1, wherein logic resources implements a QC protocol for an optical measurement to assure wetting of a strip test area at a selected time.

13. The apparatus of claim 1, wherein logic resources implements a QC protocol for an optical measurement to assure wetting of a strip test area in measurement chamber at a selected time following application of pressure to a sample pressurization.

14. The apparatus of claim 1, wherein logic resources implements a QC protocol for an optical measurement of flow path to assure sample movement to specific point in a flow path at predetermined time from sample pressurization.

15. The apparatus of claim 1, wherein logic resources implements a QC protocol for an optical measurement of a flow path to assure sample removal from a specific point in a flow path and replaced by a diluent at a predetermined time from dilutent pressurization.

16. The apparatus of claim 1, wherein logic resources implements a QC protocol for an optical measurement of an assay cell in measurement chamber.

17. The apparatus of claim 1, wherein logic resources implements a QC protocol for an optical measurement of an assay cell in measurement chamber to assure that diluted sample arrives at a selected measurement region and at a selected time from mixed sample pressurization.

18. The apparatus of claim 1, wherein logic resources implements a QC protocol for an electrical measurement of an assay cell to assure that a calibrant has sufficiently filled measurement chamber.

19. The apparatus of claim 1, wherein logic resources implements a QC protocol for an electrical measurement of an assay cell to assure that a calibrant has sufficiently filled measurement chamber by a selected time from calibrant pressurization.

20. The apparatus of claim 1, wherein logic resources implements a QC protocol for an electrical measurement of the assay cell to assure that the sample has sufficiently filled the chamber by a selected time from sample pressurization.

21. The apparatus of claim 1, wherein the sensor detects changes of the sample in measurement chamber selected from at least one of, light reflection characteristics, light absorption characteristics, and light fluorescence characteristics

22. The apparatus of claim 2, wherein the monitor device is configured to detect changes in measurement chamber, and in response to the changes determine if there is a sufficient amount of at least one of sample, reagent in measurement chamber.

23. The apparatus of claim 2, wherein the reagent is selected from a calibrant, a fluid containing reactant, or a fluid not containing a reactant.

24. The apparatus of claim 2, wherein the flow cell includes bibulous materials.

25. The apparatus of claim 2, wherein the flow cell includes non-bibulous materials.

26. The apparatus of claim 25, wherein the non-bibulous materials includes a surface that has measurement chemistry and a second surface that is filled to the first surface that provides a window viewable by the sensor.

27. The apparatus of claim 24, wherein at least a portion of flow is induced by the bibulous material and is open to the atmosphere.

28. The apparatus of claim 1, wherein the flow cell includes at least one reactive antibody.

29. The apparatus of claim 28, wherein the reactive antibody is on a surface of the flow cell.

30. The apparatus of claim 29, wherein the reactive antibody is immobilized in a flow path of the flow cell.

31. The apparatus of claim 1, wherein the monitor device includes a light source.

32. The apparatus of claim 31, wherein the source is an LED or LED array

33. The apparatus of claim 31, wherein the light source is a blue light emitting diode.

34. The apparatus of claim 31, wherein the light source is a red light emitting diode.

35. The apparatus of claim 1, wherein the sensor is a photo sensor.

36. The apparatus of claim 35, wherein the photo sensor is a charge coupled device.

37. The apparatus of claim 35, wherein the photo sensor is a photo detector or an array.

38. The apparatus of claim 35, wherein the photo sensor is a PMT.

39. The apparatus of claim 35, wherein the photo sensor is a CMOS.

40. The apparatus of claim 35, wherein the photo sensor is coupled to a digital image processing circuit.

41. The apparatus of claim 35, further comprising:

a focusing member positioned to provide a focusing of the output beam to the photo sensor.

42. The apparatus of claim 1, wherein at least a portion of the flow cell is made of a material that is transparent

43. The apparatus of claim 1, wherein the flow cell is configured to be position-able in a test instrument.

44. The apparatus of claim 1, further comprising:

a test cartridge that includes a housing configured to receive at least a portion of the flow cell.

45. The apparatus of claim 29, further comprising:

a least one dye mixed with the antibody.

46. The apparatus of claim 45, wherein the at least one dye produces a base line image data with different characteristics.

47. The apparatus of claim 46, wherein the different characteristics are different light intensities.

48. The apparatus of claim 1, wherein the flow cell includes an inlet, and outlet and a channel coupled to measurement chamber.

49. The apparatus of claim 48, wherein inlet is configured to provide for introduction of the sample into the inlet by laminar flow.

50. The apparatus of claim 49, wherein sample introduction is by absorption.

51. The apparatus of claim 48, wherein the inlet is configured to provide for introduction of the sample into the inlet with the use of a pump.

52. The apparatus of claim 1, wherein the light source includes multiple light sources.

53. The apparatus of claim 52, wherein the multiple light sources monitor different test processes using image data formed from different light beam s.

54. A method for determining the presence of at least one biological analyte that may be present in a liquid sample comprising:

providing an apparatus for testing fluid samples that includes a flow cell with a measurement chamber, a monitor device that directly monitors flow of a sample and a reagent into measurement chamber, a light source that produces an incident beam directed to measurement chamber; and

a sensor positioned to receive an output beam from the flow cell;

introducing the liquid sample into the flow cell;

directly monitoring flow of a sample and a reagent into measurement chamber; and

providing in a real time basis a sensing of a sample or a reagent without relying on information that originates outside the flow cell.

55. The method of claim 54, wherein the information that originates the flow cell includes a mechanical, electrical or photo within the apparatus outside of the flow cell.

56. The method of claim 54, wherein the mechanical information includes pump movement or valve rotation within the apparatus.

57. The method of claim 54, wherein real time is a frequency of measurement to insure that the reaction in a selected time period.

58. The method of claim 57, wherein real time is in the range of 1 second to 1 minute.

62. The method of claim 54, wherein the sample is an analyte that contacts and reacts with an antibody in measurement chamber.

63. The method of claim 62, wherein a validity of a test result is sensitive to an exposure time of the biological analyte in the sample to the antibody.

64. The method of claim 62, further comprising:

monitoring a time duration of the sample in the flow cell.

65. The method of claim 64, wherein monitoring time duration of the sample in the flow cell assists in the quality of a test process.

66. The method of claim 54, wherein the photo sensor detects and processes the output beam reflected from the sample in the sample chamber.

67. The method of claim 66, wherein the output beam is light intensity at specific wavelengths

68. The method of claim 66, further comprising:

detecting different light absorption and reflection characteristics of the output beam.

69. The method of claim 68, wherein the different light absorption and reflection characteristics selected from at least one of, intensity, wavelength, polarity and scatter.

70. The method of claim 68, further comprising:

using the output beam to compare a timing and a sequence of changes during different times of biological analyte activity in the flow cell.

71. The method of claim 70, wherein a blood sample in the flow cell absorbs at least a portion of the incident beam and reduces an intensity of the output beam.

72. The method of claim 71, where the sensor detects a substantially dark image that is indicative of a presence of the blood sample in flow cell.

73. The method of claim 54, further comprising:

introducing a wash fluid to the reactive chamber after the biological analyte in the sample is exposed to the antibody.

74. The method of claim 73, wherein the wash fluid is selected from at least one of a liquid, gas or an airflow.

75. The method of claim 74, wherein the wash fluid displaces sample out of measurement chamber.

76. The method of claim 75, wherein the wash fluid removes the sample from measurement chamber except for a portion of biological analyte in the sample that has reacted with and held by the antibody.

77. The method of claim 76, wherein an intensity of the output beam increases as the sample is removed from measurement chamber.

78. The method of claim 76, wherein the sensor provides an indication of a completeness of sample removal from measurement chamber.

79. The method of claim 78, further comprising:

introducing an airflow into measurement chamber following introduction of the wash fluid into measurement chamber, wherein the wash fluid is a liquid.

80. The method of claim 79, further comprising:

utilizing the detector to monitor the airflow.

81. The method of claim 76, further comprising:

introducing a reagent to measurement chamber that reacts with biological analyte retained by the antibody in measurement chamber.

82. The method of claim 76, wherein light reflected from reagent solution in the flow cell has different characteristics than light reflected from reactive antibody in measurement chamber.

83. The method of claim 82, wherein light reflected from reagent solution in the flow cell has different characteristics than light reflected from wash fluid in the flow cell.

84. The method of claim 83, wherein the different characteristics are selected from, wavelength, intensity, capacitance, and conductivity

85. The method of claim 84, wherein different wavelengths are an indicator of different substances in the flow cell.

86. The method of claim 54, wherein the sensor detects changes of the sample in measurement chamber selected from at least one of, light reflection characteristics, light absorption characteristics, light fluorescence characteristics, capacitance, and conductivity.

87. The method of claim 54, wherein the sensor monitors the test process by processing image data of light characteristics of the sample and reagents in the flow cell.

59. A method for determining the presence of at least one biological analyte that may be present in a sample comprising:

providing an apparatus for testing fluid samples that includes a flow cell with a measurement chamber;

introducing the sample into the flow cell, directly monitoring flow of at least one of a sample or a reagent into measurement chamber;

illuminating at least a portion of measurement chamber and acquiring a digital image of the antibody; and

producing an output signal indicative of the biological analyte in real time.

60. The method of claim 59, wherein real time is a frequency of measurement to insure that the reaction in a selected time period.

61. The method of claim 59, wherein real time is in the range of 1 second to 1 minute.