Sample collection and testing system

• US 20030209653A1
• Filed: 01/30/2003
• Published: 11/13/2003
• Est. Priority Date: 04/24/2002
• Status: Abandoned Application

• Current Assignee: BioControl Systems, Inc. (Merck & Co., Inc.)
• Original Assignee: BioControl Systems, Inc. (Merck & Co., Inc.)
• Inventors: Feldsine, Philip T., Kelly, Tim A., Christensen, Jim, Andersen, Mark, Di Carlo, Joseph B., Kressner, Anita
• Application Number:
  US10/356,715
• Publication Number:
  US 20030209653A1
• Time in Patent Office: Days
• US Class Current: 250/214R
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence

Abstract

Methods and apparatus for evaluating the quality of a sample of a product, an ingredient, an environment or a process by measuring multiple parameters thereof, including light emitted from a reacting sample containing ATP, ADP, alkaline phosphatase or other parameters such as pH, temperature, conductivity, oxidation reduction potential, dissolved gases, specific ions, and microbiological count. The apparatus comprises an integrated sample testing device used to collect a sample, mix reagents, react the sample, and collect it in a measurement chamber. The apparatus also comprises an instrument having a photon detection assembly for use with the sample testing device. The instrument can also comprise one or more sensing probes and a communication port to facilitate data collection, transfer and analysis. The method further comprises a mechanism for storing data, evaluating data, graphing data, and determining conformance to established criteria.

Claims

1. An instrument for use in measuring a sample taken from a product, an ingredient, an environment or process, the instrument comprising:

a photon detection assembly with a photon detector and a dark chamber; and

a communication port capable of receiving a signal from an additional measurement device other than the photon detector of the photon detection assembly.

2. The instrument of claim 1 wherein the additional measurement device is capable of measuring at least one of ATP level, ADP level, AP level, alkaline phosphatase level, pH, temperature, dissolved gases, conductivity, oxidation reduction potential, microbiological count, and specific ions.

3. The instrument of claim 1 wherein the photon detector is a photon counter.

4. The instrument of claim 3 wherein the photon counter comprises a photo-multiplier tube or photodiode.

5. The instrument of claim 3 wherein the additional measurement device is an external probe, which may be fixed or removable from the instrument.

6. The instrument of claim 5 wherein the external probe is interchangeable with other external probes.

7. The instrument of claim 5 wherein the external probe is capable of measuring different parameters.

8. The instrument of claim 5 wherein the external probe is capable of measuring a single parameter different from the photon detector.

9. The instrument of claim 7 wherein the external probe is capable of measuring different parameters simultaneously.

10. The instrument of claim 7 wherein the different parameters include at least one of temperature, pH, dissolved gases, conductivity, oxidation reduction potential, and specific ions.

11. A measurement instrument comprising:

a photo-multiplier tube or photodiode;

a reading chamber for retaining a light emitting sample to be analyzed using the photo-multiplier tube or photodiode; and

a communication port that allows the instrument to receive a signal from an additional measurement device, the measurement device being capable of measuring a parameter other than photon count.

12. The instrument of claim 11 wherein the measurement device comprises an external probe.

13. The instrument of claim 12 wherein the external probe is capable of measuring at least one of temperature, pH, dissolved gases, conductivity, oxidation reduction potential, and specific ions.

14. The instrument of claim 12 wherein the external probe is capable of measuring a plurality of different parameters.

15. The instrument of claim 12 wherein the external probe is capable of measuring a single different parameter.

16. The instrument of claim 14 wherein at least one of the plurality of different parameters is temperature, pH, dissolved gases, conductivity, oxidation reduction potential, or specific ions.

17. The instrument of claim 11 wherein the communication port is capable of receiving signals from any of a plurality of interchangeable measurement devices.

18. The instrument of claim 17 wherein the plurality of interchangeable measurement devices comprise devices for measuring different parameters.

19. The instrument of claim 17 wherein the plurality of interchangeable measurement devices comprise an external probe, which may be fixed or detachable from the instrument.

20. The instrument of claim 17 wherein the plurality of interchangeable measurement devices comprise a plurality of external probes, with at least two of the external probes being capable of measuring different parameters.

21. The instrument of claim 20 wherein at least one of the external probes is capable of measuring temperature, pH, dissolved gases, conductivity, oxidation reduction potential, or specific ions.

22. The instrument of claim 11 wherein the instrument comprises a plurality of communication ports each capable of receiving a signal from a separate measurement device.

23. The instrument of claim 22 wherein at least one of the communication ports is capable of communicating with a general purpose computer.

24. The instrument of claim 23 wherein at least one of the communication ports is capable of communicating with a data logger.

25. The instrument of claim 23 wherein at least one of the communication ports is capable of communicating with an external memory system.

26. The instrument of claim 22 wherein at least two of the separate measurement devices measure different parameters.

27. The instrument of claim 26 wherein at least one of the separate measurement devices is an external probe.

28. The instrument of claim 27 wherein the external probe is capable of measuring temperature, pH, dissolved gases, conductivity, oxidation reduction potential, or specific ions.

29. An instrument for detecting light emission from a sample, the instrument comprising:

a photon detector;

a chamber for receiving a sample to be analyzed using the photon detector, the chamber being adjacent the photon detector and having a shutter member rotatably attached thereto, the shutter member being selectively positionable to be open or closed, wherein when the shutter member is open, the photon detector can be exposed to light from a sample in the chamber, and when the shutter member is closed, the photon detector is blocked from light in the chamber or external light entering the chamber; and

a holding member for positioning the sample, the holding member being configured so that movement thereof can rotate the shutter member.

30. The instrument of claim 29 further comprising a communication port for connecting a measurement device to the instrument, the measurement device being capable of measuring a parameter in addition to that supplied by the photon detector.

31. The instrument of claim 29 further comprising a cover for the chamber, the instrument being configured such that the cover must be in a closed position in order for the shutter member to be open, and the cover can be selectively positionable between an open position or closed position when the shutter member is closed.

32. The instrument of claim 31 further comprising a movable shaft, the movable shaft being coupled to the shutter member such that when the cover is closed, displacement of the moveable shaft can open or close the shutter member.

33. The instrument of claim 31 further comprising a slidable shaft that can be displaced between an up position and a down position to position the instrument between a sample loading position and sample measurement position, the slidable shaft being coupled to the shutter member such that when the cover is closed, displacement of the slidable shaft from the up position to the down position opens the shutter member.

34. The instrument of claim 31 further comprising an elevator mechanism capable of propelling the slidable shaft from the down position to the up position.

35. The instrument of claim 34 wherein the shutter member is cylindrically shaped.

36. The instrument of claim 31 wherein the shutter member has an opening that can be rotated to face the photon detector to open the shutter member.

37. The instrument of claim 31 wherein the holding member is capable of retaining a sample testing device and the instrument is capable of analyzing the sample from within the sample testing device.

38. The instrument of claim 37 further comprising a positioning member to position the sample testing device in close and reproducible proximity to the photon detector.

39. The instrument of claim 37 wherein the instrument is configured to position a sample collection surface within the sample testing device in close proximity to a photon sensing path of the photon detector but not within the photon sensing path.

40. An instrument for detecting photon emission, the instrument comprising:

a photon detector;

a holding chamber for receiving and holding a sample device, the holding chamber having a cover that can be opened to load the sample device in the holding chamber;

an elevator mechanism, the holding chamber being connected to the elevator mechanism with the elevator mechanism being capable of positioning the holding chamber in a first position for loading the sample device and in a second position such that a sample containing portion of the sample device is in a measurement path of the photon detector;

a shutter coupled to the elevator mechanism, the shutter being configured to open to expose the sample to the photon detector when the sample is positioned in a measurement position and to block light from the photon detector when the sample is withdrawn from the measurement position for removal from the instrument; and

a communication port for connecting a measurement device to the instrument, the measurement device being capable of measuring a parameter in addition to that supplied by the photon detector.

41. A sample testing device comprising:

a liquid chamber;

a reagent chamber;

a sample measurement chamber for retaining sample to be analyzed;

a sample collection member used to collect sample from an environment to be analyzed; and

a displacement member, the sample testing device being configured such that movement of the displacement member mixes liquid from the liquid chamber with reagent from the reagent chamber and propels the liquid and reagent into contact with the sample collection member to liberate sample from the sample collection member, the displacement of the displacement member also driving the liquid and reagent into the sample measurement chamber.

42. The sample testing device of claim 41 wherein the reagent chamber is sealed and displacement of the displacement member releases reagent from the reagent chamber.

43. The sample testing device of claim 42 wherein displacement of the displacement member causes reagent to be released by forcing a piercing member through a portion of the reagent chamber.

44. The sample testing device of claim 41 further comprising a piercing tip, wherein displacement of the displacement member causes the reagent chamber to be displaced and to come into contact with the piercing tip thereby releasing reagent.

45. The sample testing device of claim 41 wherein when the sample testing device is fully assembled and inserted in a photon detection instrument, the sample collection member is outside of the photon sensing path of the photon detection instrument while at least a portion of the sample measurement chamber is within the photon sensing path.

46. A sample testing device comprising:

a displacement member configured to be manually actuated;

a chamber configured to release a reagent when the displacement member is actuated;

a channel through which the reagent is propelled by actuation of the displacement member, the channel also being disposed to receive liquid to facilitate mixing of the reagent with the liquid and to direct the reagent and liquid in a flow path toward a measurement portion of the sample testing device;

a sample collection surface disposed in the flow path of the reagent such that actuation of the displacement member causes the reagent to come into contact with the sample collection surface to release a sample into the reagent; and

a measurement chamber of the test device into which the reagent is delivered by the actuation of the displacement member, the measurement chamber providing a chamber in the sample testing device in which to hold the reagent while a parameter thereof is being measured.

47. The sample testing device of claim 46 wherein the measurement chamber extends beyond an end of the sample collection surface so that the sample collection surface is not disposed in a measurement path of a detector used to measure a parameter of the sample within the measurement chamber.

48. The sample testing device of claim 47 wherein the sample collection surface is configured to remain in contact with reagent delivered into the measurement chamber by the displacement member, such that the reagent can continuously liberate sample from the sample collection surface while the parameter of the sample is being measured.

49. The sample testing device of claim 46 wherein there are a plurality of reagents and a plurality of chambers configured to release the plurality of reagents when the displacement member is actuated.

50. The sample testing device of claim 49 wherein the measurement chamber is continuous and optically uniform.

51. The sample testing device of claim 49 wherein the measurement chamber is clear.

52. The sample testing device of claim 49 is translucent but allows photon passage to the detector.

53. The sample testing device of claim 49 wherein at least one of the reagents is in dry form.

54. A sample testing device for use with a photon detector, comprising:

a sample measurement chamber;

a sample collection member for use in collecting a sample to be analyzed;

a joining member for connecting the sample collection member to the sample measurement chamber, the sample collection member being configured such that when it is joined to the sample measurement chamber by the joining member, it remains outside of a portion of the sample measurement chamber that is placed in a photon sensing path when the sample testing device is used with a photon detector.

55. The sample testing device of claim 54 further comprising a liquid chamber configured to deliver a specific amount of liquid to the sample measurement chamber to occupy a volume extending beyond the area of the photon sensing path and to be in fluid communication with the sample collection member when the collection member is connected to the sample measurement chamber.

56. The sample testing device of claim 55 further comprising a displacement member capable of displacing sample from the sample collection member into the sample measurement chamber.

57. A method of testing a sample comprising:

providing a testing device having a reagent chamber;

actuating a displacement member of the testing device to drive reagent from the reagent chamber into contact with a sample collection member to liberate sample therefrom, the actuation of the displacement member also driving reagent from the reagent chamber into a sample measurement chamber of the testing device; and

placing the sample measurement chamber in a photon sensing path to measure photon emission of a sample collected on the sample collection member.

58. The method of claim 57 further comprising mixing the reagent in the chamber with a liquid by actuation of the displacement member.

59. The method of claim 58 further comprising maintaining the sample collection member outside of the photon sensing path during measurement of photon emission of the sample.

60. The method of claim 59 wherein measurement of photon emission from the sample comprises placing at least a portion of the reagent in the sample measurement chamber within the photon sensing path and maintaining the sample collection member in contact with the reagent.

61. A method of testing a sample, the method comprising:

providing a testing device having a plurality of separate chambers with at least one of the chambers containing a liquid and with at least one of the other chambers containing a reagent;

actuating a displacement member of the testing device to release the liquid and reagent from the chambers;

mixing the liquid and reagent to form a solution using a pressure gradient created by the actuation of the displacement member;

contacting a sample collection surface and liberating sample from the surface with the solution using the pressure gradient created by the actuation of the displacement member to drive the solution past the sample collection surface; and

forcing the sample containing solution into a measurement chamber using the pressure gradient created by the actuation of the displacement member.

62. The method of claim 61 wherein the displacement member of the testing device can be easily actuated by a user using only one hand.

63. The method of claim 61 further comprising using an instrument to measure light emission from the sample containing solution.

64. The method of claim 63 further comprising measuring a parameter in addition to light emission using the instrument.

65. The method of claim 64 wherein the additional parameter is at least one of temperature, pH, dissolved gases, conductivity, oxidation reduction potential, or specific ions.

66. A method of monitoring a sample of a product, an ingredient, the environment, a process comprising:

providing an instrument having a photon detector and a communication port for communicating with a measurement device, the measurement device being capable of measuring a parameter in addition to a parameter measured by the photon detector;

providing the measurement device to be coupled to the instrument through the communication port;

collecting a sample from a product or an ingredient, the environment or a process and placing the sample in a chamber for analysis using the photon detector;

analyzing the sample using the photon detector; and

measuring a parameter of the product, the ingredient, the environment or process using the measurement device.

67. The method of claim 66 wherein data received from the photon detector and the measurement device represents selected CCP indicators.

68. The method of claim 67 further comprising analyzing the data using a processor of the instrument to correlate to a CCP limit.

69. The method of claim 66 further comprising displaying data from the photon detector and the measurement device on a display device of the instrument.

70. The method of claim 69 further comprising displaying data from the instrument in graphical or chart form to facilitate data analysis, the display of that data and the analysis thereof being carried out by a processor of the instrument or an external processor.

71. The method of claim 66 further comprising recording data from the photon detector and the measurement device on a memory of the instrument.

72. The method of claim 66 further comprising recording data from the instrument in a random access configuration such that the user may allocate any amount of memory to each parameter being measured.

73. The method of claim 66 wherein the instrument comprises a plurality of communication ports and at least one of the communication ports is used to transfer data received from the photon detector and the measurement device to an external device.

74. The method of claim 73 wherein the external device comprises a processor used to analyze the data.

75. The method of claim 74 wherein the external device is a general-purpose computer.

76. The method of claim 73 wherein the external device comprises a data storage device.

77. The method of claim 73 wherein the external device is a general purpose computer and the data storage device is a hard disk coupled to the general purpose computer.

78. The method of claim 66 further comprising using a processor of the instrument to analyze data received from the photon detector and the measurement device.

79. The method of claim 78 wherein using the processor to analyze the data comprises providing software to be used with the instrument processor to indicate correlation with a CCP limit.

80. The method of claim 78 wherein the processor used to analyze the data may be internal to the instrument, external to the instrument, or any combination thereof.

81. The method of claim 66 wherein measuring a parameter of a sample of the product, an ingredient, the environment or the process using the instrument comprises providing a measurement proportional to at least one of ATP level, ADP level, alkaline phosphatase level, temperature, conductivity, oxidation reduction potential, pH, dissolved gases, specific ions, and microbiological count.

82. A method of facilitating an evaluation of at least one test point, comprising:

storing a set of ATP data to a first data structure; and

storing at least one of a set of temperature data or a set of pH data to the first data structure.

83. The method of claim 82 wherein storing at least one of a set of temperature data or a set of pH data to the first data structure includes storing both the set of temperature data and the set of pH data to the first data structure.

84. The method of claim 82, further comprising:

graphing the ATP data and the at least one of the set of temperature data or the set of pH data on a same graph.

85. The method of claim 82, further comprising:

graphing the set of ATP data, the set of temperature data and the set of pH data on a same graph.

86. The method of claim 82, further comprising:

graphing the set of ATP data, and the set of temperature data or the set of pH data along a parallel axes of a same graph.

87. The method of claim 82 wherein storing a set of ATP data to a first data structure includes storing a respective zone of cleanliness value for each of the test points.

88. The method of claim 82 wherein storing a set of ATP data to a first data structure includes storing a respective relative light unit (RLU) for each of the test points.

89. The method of claim 82 wherein storing a set of ATP data to a first data structure includes storing a number of test point identifiers corresponding to each of a number of test points, a respective zone of cleanliness or RLU for each of the test points, and a pass/warning/failure indicator for each of the test points.

90. The method of claim 82 wherein storing a set of temperature data to the first data structure includes storing at least one temperature value corresponding to a temperature of an item that passed the test point.

91. The method of claim 82 wherein storing a set of temperature data to the first data structure includes storing at least one temperature value corresponding to a temperature of an item that passed the test point, and a temperature pass/failure indicator for the item that passed the test point.

92. The method of claim 82 wherein storing a set of pH data to the first data structure includes storing at least one pH value corresponding to a pH of an item that passed the test point.

93. The method of claim 82 wherein storing a set of pH data to the first data structure includes storing at least one pH value corresponding to a pH of an item that passed the test point, and a pH pass/failure indicator for item that passed the test point.

94. The method of claim 82 wherein storing a set of ATP data to a first data structure is combined with storing at least one set of data from a second parameter including, but not limited to, conductivity, oxidation reduction potential, protein residues, dissolved gases or specific ions.

95. A computer-readable media storing instructions for causing a computer to facilitate an evaluation of at least one test point, by:

storing a set of ATP data to a first data structure; and

storing at least one of a set of temperature data and a set of pH data to the first data structure.

96. The computer-readable media of claim 95 wherein the instructions cause the computer to store both the set of temperature data and the set of pH data to the first data structure.

97. The computer-readable media of claim 95 wherein storing a set of ATP data and at least one set of data from a second parameter including, but not limited to, conductivity, oxidation reduction potential, protein residues, dissolved gases or specific ions.

98. The computer-readable media of claim 95 storing instructions for causing the computer to facilitate the evaluation of a test point, further by:

graphing the ATP data and the at least one of the set of temperature data or the set of pH data on a same graph.

99. The computer-readable media of claim 95 storing instructions for causing the computer to facilitate the evaluation of a test point, further by:

graphing the set of ATP data, the set of temperature data and the set of pH data on a same graph.

100. The computer-readable media of claim 95 storing instructions for causing the computer to facilitate the evaluation of a test point, further by:

graphing the set of ATP data and at least one set of data from a second parameter, including, but not limited to, conductivity, oxidation reduction potential, protein residues, dissolved gases or specific ions.

101. The computer-readable media of claim 95 storing instructions for causing the computer to facilitate the evaluation of a test point, further by:

graphing the set of ATP data, the set of temperature data and the set of pH data along a parallel axes of a same graph.

102. The computer-readable media of claim 95 wherein storing a set of ATP data to a first data structure includes storing a respective zone of cleanliness or a RLU value for each of the test points.

103. The computer-readable media of claim 95 wherein storing a set of ATP data to a first data structure includes storing a number of test point identifiers corresponding to each of a number of test points, a respective zone of cleanliness value for each of the test points, and a pass/warning/failure indicator for each of the test points.

104. The computer-readable media of claim 95 wherein storing a set of temperature data to the first data structure includes storing at least one temperature value corresponding to a temperature of an item that either passed or failed the test point.

105. The computer-readable media of claim 95 wherein storing a set of temperature data to the first data structure includes storing at least one temperature value corresponding to a temperature of an item that passed the test point, and a temperature pass/failure indicator for the item that either passed or failed the test point.

106. The computer-readable media of claim 95 wherein storing a set of ATP data to a first data structure is combined with storing at least one set of data from a second parameter including, but not limited to, conductivity, oxidation reduction potential, protein residues, dissolved bases or specific ions.

107. The computer-readable media of claim 95 wherein:

storing a set of pH data to the first data structure includes storing at least one pH value corresponding to a pH of an item that passed the test point.

108. The computer-readable media of claim 95 wherein storing a set of pH data to the first data structure includes storing at least one pH value corresponding to a pH of an item that passed the test point, and a pH pass/failure indicator for item that passed the test point.

109. A method of facilitating an evaluation of at least one test point, comprising:

graphing a set of ATP data along a first axis of a graph; and

graphing at least one of a set of temperature data, a set of pH data, a set of conductivity data, a set of oxidation reduction potential data, a set of pressure data, and a set of dissolved gas data along at least a second axis of the graph.

110. The method of claim 109, further comprising:

storing a set of ATP data to a first data structure before graphing; and

storing at least one of a set of temperature data, a set of pH data, a set of conductivity data, a set of oxidation reduction potential data, a set of pressure data, a set of specific ion data, and a set of dissolved gas data to the first data structure before graphing.