Diagnostic systems and instruments

• US 9,081,001 B2
• Filed: 03/15/2013
• Issued: 07/14/2015
• Est. Priority Date: 05/15/2012
• Status: Active Grant

• Current Assignee: Wellstat Diagnostics, LLC
• Original Assignee: Wellstat Diagnostics, LLC
• Inventors: Cook, Richard Alan, Cho, Sang, Davis, Charles Quentin, Dorsey, Kevin E, Harley, Jason Charles, Leland, Jonathan, Matikyan, Rober Krikor, Otten, Sjef, Peterman, Jeffrey Howard, Thomas, Brian B
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US13/844,450
• Publication Number:
  US 20130315780A1
• Time in Patent Office: 851 Days
• Field of Search: 422/52, 422/73, 422/82.01, 422/82.05, 422/82.06, 422/82.07, 422/82.08, 422/82.09, 422/82.11, 422/407, 422/501, 422/502, 422/503, 422/504, 422/507, 436/17, 436/43, 436/63, 436/94, 436/149, 436/164, 436/172, 436/174, 436/177, 436/517, 436/518, 436/805, 436/809, 435/4, 435/6.1, 435/6.11, 435/6.12, 435/7.1, 435/7.92, 435/29, 435/288.5
• US Class Current: 1/1
• 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 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/105 using desiccants
• CPC Class Codes: B01L 3/527 for a plurality of reagents
• CPC Class Codes: B65B 1/04 Methods of, or means for, filling the material into the containers or receptacles
• CPC Class Codes: B65B 3/04 Methods of, or means for, filling the material into the containers or receptacles
• CPC Class Codes: B65B 5/04 Packaging single articles
• CPC Class Codes: B65B 55/00 Preserving, protecting or purifying packages or package contents in association with packaging by packaging under special atmospheric or gaseous conditions B65B31/00; devices for placing protecting sheets, plugs, or wads over contents B65B61/22
• CPC Class Codes: F04B 49/065 and making use of computers
• CPC Class Codes: F04B 49/106 Responsive to pumped volume
• CPC Class Codes: G01N 21/66 electrically excited, e.g. electroluminescence
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/536 with immune complex formed in liquid phase
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/58 involving labelled substances G01N33/53 takes precedence
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums
• CPC Class Codes: H05B 1/025 : For medical applications
• CPC Class Codes: Y10T 436/25 : including sample preparation
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

Provided is a clinical diagnostic system that comprises a diagnostic instrument and a disposable cartridge. The diagnostic system can be used to measure assays in point of care clinical settings.

Claims

1. A diagnostic system having a closed fluidic pathway, comprising:

a diagnostic instrument comprising;

at least two probes;

a diagnostic fluidic pathway;

a non-electrochemiluminescence (ECL) detection system;

an ECL detection system fluidically connected to the non-ECL detection system; and

a pump;

a cartridge comprising;

at least one needle;

at least one reservoir;

at least one fluidic seal; and

at least one fluidic channel,

wherein the closed fluidic pathway comprises the diagnostic fluidic pathway of the diagnostic instrument; and

the at least one fluidic channel of the cartridge begins at the at least one needle of the cartridge, passes through the diagnostic instrument, and ends at the at least one reservoir of the cartridge, and is capable of providing fluid from the cartridge to the diagnostic instrument.

2. The diagnostic system of claim 1, wherein the at least two probes are capable of engaging with the at least one reservoir, and

wherein the at least two probes comprise a first probe capable of engaging with the cartridge and/or a waste probe capable of engaging the cartridge.

3. The diagnostic system of claim 2, wherein the first probe fluidically connects to a first reservoir of the cartridge.

4. The diagnostic system of claim 3, further comprising diagnostic reagents provided within the first reservoir.

5. The diagnostic system of claim 2, wherein the waste probe fluidically connects to a waste reservoir of the cartridge.

6. The diagnostic system of claim 5, wherein the closed fluidic pathway ends in the waste reservoir.

7. The diagnostic system of claim 2, wherein the diagnostic system further comprises a motion assembly in the diagnostic system.

8. The diagnostic system of claim 7, wherein the motion assembly has two axes mechanically connected to the first probe and the waste probe.

9. The diagnostic system of claim 1, wherein the at least one reservoir comprises a first reservoir and a waste reservoir within the closed fluidic pathway.

10. The diagnostic system of claim 9, wherein the at least one reservoir is capable of being used multiple times including providing liquids.

11. The diagnostic system of claim 9, wherein the at least one reservoir is capable of being used multiple times including receiving liquids.

12. The diagnostic system of claim 9, wherein when the first reservoir is emptied, the first reservoir is capable of being used as the waste reservoir.

13. The diagnostic system of claim 1, wherein the diagnostic instrument further comprises a motion assembly,

wherein the cartridge comprises two or more reservoirs, and

wherein the motion assembly is capable of positioning the cartridge such that a first of the two or more reservoirs is part of the closed fluidic pathway and re-positioning the cartridge such that a second of the two or more reservoirs is a part of the closed fluidic pathway when the first of the two or more reservoirs is not part of the closed fluidic pathway.

14. The diagnostic system of claim 1, wherein the diagnostic fluidic pathway comprises one or more components capable of carrying fluids through the diagnostic instrument, and wherein a first of the one or more components has a diameter that is the same as or smaller than the diameter of a second of the one or more components.

15. The diagnostic system of claim 1, wherein the closed fluidic pathway is capable of reducing the potential for carryover between the diagnostic instrument and the cartridge.

16. The diagnostic system of claim 1, wherein the closed fluidic pathway prevents carryover between one or more different cartridges used with the diagnostic instrument such that there is substantially no detectable carryover between diagnostic tests of one or more different cartridges.

17. The diagnostic system of claim 1, wherein the at least two probes comprise a first probe and a waste probe,

wherein the at least one reservoir comprises a first reservoir and a waste reservoir, and

wherein the closed fluidic pathway runs from the first reservoir to the first probe, to the non-ECL detection system, to the ECL detection system, to the pump, to the waste probe, and to the waste reservoir.

18. The diagnostic system of claim 1, wherein at least one reagent and at least one waste material are stored in the cartridge.

19. The diagnostic system of claim 1, wherein the closed fluidic pathway does not store any of a sample, a liquid and at least one reagent in the diagnostic instrument.

20. The diagnostic system of claim 1, wherein a sample provided in the cartridge passes through the closed fluidic pathway originating in the cartridge to the closed fluidic pathway of the diagnostic instrument, and substantially all of the sample ends in the at least one reservoir in the cartridge.

21. The diagnostic system of claim 1, wherein all fluids are stored on the cartridge.

22. The diagnostic system of claim 1, wherein all dry reagents are stored on the cartridge.

23. A diagnostic system having a closed fluidic pathway, comprising:

a diagnostic instrument having a set of fluidic control elements, comprising;

a non-electrochemiluminescence (ECL) detection system;

a first probe fluidically connected to the non-ECL detection system by at least one fluidic tube;

an ECL detection system fluidically connected to the non-ECL detection system by at least one fluidic tube;

a pump fluidically connected to the ECL detection system by at least one fluidic tube and fluidically connected to a waste probe by at least one fluidic tube; and

a motion assembly having two axes mechanically connected to the first probe and the waste probe; and

a cartridge, comprising;

at least one needle;

at least one reservoir;

at least one fluidic seal; and

at least one fluidic channel, wherein the closed fluidic pathway has a substantially single direction of flow in a pathway fluidically connecting the diagnostic instrument and the cartridge.

24. The diagnostic system of claim 23, wherein the at least one reservoir comprises a first reservoir and a waste reservoir within the closed fluidic pathway.

25. The diagnostic system of claim 24, wherein when the first reservoir is emptied, the first reservoir is capable of being used as the waste reservoir.

26. The diagnostic system of claim 23, wherein the at least one reservoir is capable of being used multiple times including providing liquids.

27. The diagnostic system of claim 23, wherein the at least one reservoir is capable of being used multiple times including receiving liquids.

28. The diagnostic system of claim 23, wherein the first probe fluidically connects to a first reservoir of the cartridge.

29. The diagnostic system of claim 28, further comprising diagnostic reagents provided within the first reservoir.

30. The diagnostic system of claim 23, wherein the waste probe fluidically connects to a waste reservoir of the cartridge.

31. The diagnostic system of claim 30, wherein the closed fluidic pathway ends in the waste reservoir.

32. The diagnostic system of claim 23, wherein the cartridge comprises two or more reservoirs, and

wherein the motion assembly is capable of positioning the cartridge such that a first of the two or more reservoirs is part of the closed fluidic pathway and re-positioning the cartridge such that a second of the two or more reservoirs is a part of the closed fluidic pathway when the first of the two or more reservoirs is not part of the closed fluidic pathway.

33. The diagnostic system of claim 23, wherein the diagnostic fluidic pathway comprises one or more components capable of carrying fluids through the diagnostic instrument, wherein a first of the one or more components has a diameter that is the same as or smaller than the diameter of a second of the one or more components.

34. The diagnostic system of claim 23, wherein the closed fluidic pathway is capable of reducing the potential for carryover between the diagnostic instrument and the cartridge.

35. The diagnostic system of claim 23, wherein the closed fluidic pathway prevents carryover between one or more different cartridges used with the diagnostic instrument such that there is substantially no detectable carryover between diagnostic tests of one or more different cartridges.

36. The diagnostic system of claim 23, wherein the at least one reservoir comprises a first reservoir and a waste reservoir, and

wherein the closed fluidic pathway runs from the first reservoir to the first probe, to the non-ECL detection system, to the ECL detection system, to the pump, to the waste probe, and to the waste reservoir.

37. The diagnostic system of claim 23, wherein at least one reagent and at least one waste material are stored in the cartridge.

38. The diagnostic system of claim 23, wherein a sample provided in the cartridge passes through the closed fluidic pathway originating in the cartridge to the closed fluidic pathway of the diagnostic instrument, and substantially all of the sample ends in the at least one reservoir in the cartridge.

39. The diagnostic system of claim 23, wherein all fluids are stored on the cartridge.

40. The diagnostic system of claim 23, wherein all dry reagents are stored on the cartridge.

41. A diagnostic system having a closed fluidic pathway, comprising:

a diagnostic instrument comprising;

an internal standard module;

a first probe fluidically connected to the internal standard module by at least one fluidic tube;

an electrochemiluminescence (ECL) detection system fluidically connected to the internal standard by at least one fluidic tube;

a pump fluidically connected to the ECL detection system by at least one fluidic tube and fluidically connected to a waste probe by at least one fluidic tube; and

a cartridge comprising;

at least one needle;

at least one reservoir;

at least one fluidic seal; and

at least one fluidic channel, wherein the closed fluidic pathway comprises the diagnostic fluidic pathway of the diagnostic instrument; and

the at least one fluidic channel of the cartridge begins at the least one needle of the cartridge, passes through the diagnostic instrument, and ends at the at least one reservoir of the cartridge, and is capable of providing fluid from the cartridge to the diagnostic instrument.

42. The diagnostic system of claim 41, wherein the at least one reservoir comprises a first reservoir and a waste reservoir.

43. The diagnostic system of claim 42, wherein the first reservoir and the waste reservoir are the same reservoir.

44. The diagnostic system of claim 42, wherein the first reservoir and the waste reservoir are not the same reservoir.

45. The diagnostic system of claim 41, wherein the first probe fluidically connects to a first reservoir of the cartridge.

46. The diagnostic system of claim 45, wherein the first reservoir contains diagnostic reagents.

47. The diagnostic system of claim 41, wherein the waste probe fluidically connects to a waste reservoir of the cartridge.

48. The diagnostic system of claim 47, wherein the waste reservoir receives waste materials.

49. The diagnostic system of claim 48, wherein waste materials include at least one of a processed reagent, a blood filtrate, and a processed plasma.

50. The diagnostic system of claim 41, wherein the diagnostic fluidic pathway comprises one or more components capable of carrying fluids through the diagnostic instrument, and wherein a first of the one or more components has a diameter that is the same as or smaller than the diameter of a second of the one or more components.

51. The diagnostic system of claim 41, wherein the closed fluidic pathway is capable of reducing the potential for carryover between the diagnostic instrument and the cartridge.

52. The diagnostic system of claim 41, wherein the closed fluidic pathway prevents carryover between one or more different cartridges used with the diagnostic instrument such that there is substantially no detectable carryover between diagnostic tests of one or more different cartridges.

53. The diagnostic system of claim 41, wherein the at least one reservoir comprises a first reservoir and a waste reservoir, and

wherein the closed fluidic pathway runs from the first reservoir to the first probe, to the non-ECL detection system, to the ECL detection system, to the pump, to the waste probe, and to the waste reservoir.

54. The diagnostic system of claim 41, wherein at least one reagent and at least one waste material are stored in the cartridge.

55. The diagnostic system of claim 41, further comprising a motion assembly.

56. The diagnostic system of claim 55, wherein the motion assembly has two axes mechanically connected to the first probe and the waste probe.

57. The diagnostic system of claim 41, wherein all fluids are stored on the cartridge.

58. The diagnostic system of claim 41, wherein all dry reagents are stored on the cartridge.

59. A method of temperature control within the diagnostic system of claim 41, comprising:

measuring with a sensor a starting temperature of the cartridge containing a biological sample and at least one reagent;

comparing the starting temperature of the cartridge to a target temperature;

heating with a heater the cartridge to the target temperature; and

maintaining the target temperature using a closed loop control for a period of time.

60. The method of claim 59, wherein measuring the starting temperature comprises measuring with a sensor the rate of an incubator'"'"'s temperature loss after the cartridge is placed on the incubator.

61. The method of claim 60, wherein measuring the starting temperature comprises measuring with a sensor the rate of an incubator plate'"'"'s temperature loss after the cartridge is placed on the incubator plate.

62. The method of claim 60, wherein the same sensor is used to measure the starting temperature and in the closed loop control to maintain the target temperature.

63. The method of claim 60, wherein the rate of temperature loss is related to the rate that heat transfers from the incubator plate to the cartridge, and the starting temperature of the cartridge.

64. The method of claim 60, wherein the sensor is integral with the incubator plate.

65. The method of claim 60, wherein the heater is integral with the incubator plate.

66. The method of claim 59, wherein the temperature control is a closed-loop feedback control.

67. The method of claim 59, wherein maintaining the target temperature using a closed loop control comprises:

intermittently measuring with the sensor the temperature of the cartridge during operation of the diagnostic system;

comparing the cartridge temperature to the target temperature; and

heating with the heater the cartridge to the target temperature.

68. The method of claim 59, wherein the period of time is equal to or less than the time it takes for the diagnostic system to complete a full diagnostic test.

69. A method of temperature control within the diagnostic system of claim 41, comprising:

in a first zone of an incubator, measuring with a first sensor a starting temperature of a portion of the cartridge containing a biological sample and at least one reagent, wherein the cartridge is shorter in length than the length of the incubator and the portion of the cartridge only contacts the first zone of the incubator;

comparing the starting temperature of the portion of the cartridge to a first target temperature;

heating with a first heater the portion of the cartridge to the first target temperature;

maintaining the first target temperature of a portion of the cartridge using a closed loop control for a period of time; and

in a second zone of the incubator, measuring with a second sensor a starting temperature of a second portion of the cartridge containing a biological sample and at least one reagent, wherein the second portion of the cartridge only contacts the second zone of the incubator;

comparing the starting temperature of the second portion of the cartridge to a second target temperature;

heating with a second heater the second portion of the cartridge to the second target temperature; and

maintaining the target temperature of the second portion of the cartridge using a second closed loop control for a period of time.

70. The method of claim 69, wherein the first and second zones of the multi-zone incubator operate independently of one another.

71. The method of claim 69, wherein the measurements in the first and second zones occur simultaneously during operation of the diagnostic system.

72. The method of claim 69, wherein the measurements in the first and second zones occur at different times during operation of the diagnostic system.

73. The method of claim 69, wherein the first target temperature and the second target temperature are different.

74. The method of claim 69, wherein the first target temperature and the second target temperature are the same.

75. The method of claim 69, wherein the first sensor and the second sensor are different.

76. The method of claim 69, wherein the first heater and the second heater are different.

77. The method of claim 69, wherein the period of time is equal to or less than the time it takes for the diagnostic system to complete a full diagnostic test.

78. The diagnostic system of claim 41, wherein the internal standard module comprises an apparatus for measuring bead recovery, comprising:

a housing;

a tubing assembly of the diagnostic fluidic pathway, located within the housing in fluidic communication with the ECL detection system;

a fluorescence excitation source; and

a fluorescence light detector, wherein the fluorescence excitation source is capable of emitting light such that the light reflects off of or is transmitted by the fluorescent beads in the fluid provided in the cartridge flowing through the tubing assembly of the diagnostic fluidic pathway,

wherein the fluid provided in the cartridge passes through the closed fluidic pathway originating in the cartridge to the closed fluidic pathway of the diagnostic instrument such that substantially all of the fluid ends in the at least one reservoir in the cartridge, and

wherein the fluorescence light detector is capable of measuring the amount of light reflected off of or transmitted by the beads in the fluid to determine whether an acceptable level of beads is present in the fluid indicating a positive bead recovery measurement.

79. A method of detecting and measuring bead recovery, comprising:

illuminating a fluid containing a known amount of fluorescent and non-fluorescent beads flowing through the closed fluidic pathway of the diagnostic system of claim 78;

detecting light transmitted and/or reflected by the illuminated fluorescent beads flowing through the tubing assembly of the diagnostic fluidic pathway of the diagnostic system;

converting the transmitted light and/or the reflected light into one or more measurable electrical signals;

processing the one or more measurable electrical signals to calculate an internal standard which is directly related to the amount of fluorescent beads traveling through the tubing assembly; and

comparing a magnitude of the one or more measurable electrical signals to a predicted magnitude based on the known amount of fluorescent and non-fluorescent beads within the fluid, wherein amount of the one or more measurable electrical signals is directly correlated to the amount of non-fluorescent beads present in the closed fluidic pathway of the diagnostic system.

80. A method of measuring electrochemiluminescence (ECL) bead recovery, comprising:

illuminating a fluid containing a known amount of fluorescent beads and ECL beads flowing through the tubing assembly of the diagnostic system of claim 78;

measuring fluorescence from the fluorescent beads; and

processing the measured fluorescence signal to calculate ECL bead recovery by comparing the measured fluorescence signal to a fluorescence signal from a standardized quantity of fluorescent beads.

81. The diagnostic system of claim 41, further comprising an assay composition comprising a mixture of at least one of a fluorescent labeled bead and at least one of an electrochemiluminescence (ECL) labeled bead.

82. The assay composition of claim 81, wherein beads can be both fluorescently labeled and ECL labeled.

83. A method of measuring backlash of the pump in the diagnostic system of claim 41, comprising:

sealing an area in the pump to create a chamber capable of generating pressure within the sealed area;

measuring a change in pressure within the sealed area in the pump, wherein the change in pressure is generated by a first change in the pump direction from aspirate to dispense and/or from dispense to aspirate;

measuring a change in pressure within the sealed area in the pump, wherein the change in pressure is generated by a second change in the pump direction from aspirate to dispense and/or from dispense to aspirate, and wherein the first change in the pump direction is opposite from the second change in the pump direction;

processing the change in pressure measured within the sealed area in the pump into a backlash amount; and

adjusting the desired pump volume to compensate for the backlash amount processed and measured.

84. The method of claim 83, wherein the measured backlash amount is stored and saved by the diagnostic instrument of the diagnostic system to be used repeatedly through cartridge processing cycles of the diagnostic system, wherein the stored data is capable of increasing efficiency of the diagnostic instrument for additional uses.

85. The method of claim 83, wherein the pump further comprises a pressure sensor capable of measuring the change in pressure in the sealed area of the pump.

86. The method of claim 83, wherein the pump comprises a piston and a cylinder pump.

87. The method of claim 83, wherein the pump comprises a motor driven piston and a cylinder pump.

88. The method of claim 83, wherein the pump comprises a motor driven piston, a cylinder pump, and a pressure sensor.

89. The method of claim 83, wherein the pump comprises a motor driven piston, a cylinder pump, a pressure sensor, and a flat.

90. The method of claim 83, wherein the pump comprises a close fitting ceramic piston and a cylinder pump.

91. The method of claim 83, wherein the pump is an IVEK pump.

92. The method of claim 83, wherein the pump piston comprises a flat.

93. A method to improve pump accuracy of the pump of the diagnostic system of claim 41, comprising:

measuring an amount of backlash present in the pump; and

compensating subsequent pump displacements by the amount of backlash measured in the pump, by;

sealing an area in the pump to create a chamber capable of generating pressure within the sealed area;

measuring a change in pressure within the sealed area in the pump, wherein the change in pressure is generated by a first change in the direction of a piston of the pump;

measuring a change in pressure within the sealed area in the pump, wherein the change in pressure is generated by a second change in the direction of the piston of the pump,

wherein the first change in the direction of the piston is opposite from the second change in the direction of the piston, and

wherein the first change in the direction of the piston and the second changes in direction of the piston are alternated repeatedly such that sufficient pressure to measure is generated within the sealed area;

processing the change in pressure measured within the sealed area in the pump into a backlash amount;

deriving backlash volume from the amount of backlash measured, by;

measuring the time duration that the pressure level created in the sealed area did not respond to the reversed piston motor movement; and

multiplying the time duration by piston motor rate to calculate backlash volume; and

adjusting the desired pump volume to compensate for the calculated backlash volume and improve pump accuracy.

94. The method of claim 93, wherein the chamber is isolated such that when the piston is moved the chamber is capable of generating pressure.

95. The method of claim 93, wherein the pump comprises a piston and a cylinder pump.

96. The method of claim 93, wherein the pump comprises a motor driven piston and a cylinder pump.

97. The method of claim 93, wherein the pump comprises a motor driven piston, a cylinder pump, and a pressure sensor.

98. The method of claim 93, wherein the pump comprises a motor driven piston, a cylinder pump, a pressure sensor, and a flat.

99. The method of claim 93, wherein the pump comprises a close fitting ceramic piston and a cylinder pump.

100. A method to improve pump accuracy of the pump of the diagnostic system of claim 41, comprising:

measuring for the amount of backlash present in the pump and then compensating subsequent pump displacements by the backlash by;

positioning a piston in the chamber of the pump such that the chamber is not connected to any inlet or outlet ports;

moving the piston using a piston motor until a predetermined pressure level is reached;

reversing the piston motor direction and measure pressure or vacuum;

deriving backlash volume by measuring the time duration that the pressure or vacuum level did not respond to the reversed piston motor movement, and multiplying the time duration by piston motor rate to calculate backlash volume.

101. The method of claim 100, wherein the pump comprises a piston and a cylinder pump.

102. The method of claim 100, wherein the pump comprises a motor driven piston and a cylinder pump.

103. The method of claim 100, wherein the pump comprises a motor driven piston, a cylinder pump, and a pressure sensor.

104. The method of claim 100, wherein the pump comprises a motor driven piston, a cylinder pump, a pressure sensor, and a flat.

105. The method of claim 100, wherein the pump comprises a close fitting ceramic piston and a cylinder pump.

106. The method of claim 100, wherein the pump is an IVEK pump.

107. The method of claim 100, wherein the pump piston comprises a flat.

108. The method of claim 100, wherein the pump has a dual action with linear and rotational motion.

109. A method of increasing time efficiency of the pump used in the diagnostic system of claim 41, comprising:

measuring the amount of backlash volume present in the pump through pressure changes;

processing the pressure measurement data into a backlash amount;

adjusting the desired pump volume to compensate for the backlash amount measured; and

reducing processing time of the pump based on adjustments of pump volume.

110. A method of use of a composition comprising glycol useful for lubricating the pump of the diagnostic system of claim 41, comprising:

flushing the pump immediately after use with the composition such that during periods of non-use of the pump remains primed for operation.

111. The method of claim 110, wherein the composition further comprises glycerine.

112. The method of claim 110, wherein the glycol is diethylene glycol.

113. The method of claim 110, wherein the glycol comprises at least one of ethylene glycol, triethylene glycol, tetraethylene glycol, and polyethylene.

114. The method of claim 110, wherein the composition further comprises an anti-microbial agent.

115. The method of claim 110, wherein the composition further comprises water.

116. The method of claim 110, wherein the composition is capable of being a lubricant for the pump.

117. The method of claim 110, wherein the composition comprises a non-volatile liquid.

118. The method of claim 110, wherein the composition is capable of inhibiting solid formation between a piston and a cylinder of the pump of the diagnostic system.

119. The diagnostic system of claim 41, further comprising a composition useful for lubricating the pump comprising glycol.

120. The diagnostic system of claim 41, further comprising a composition useful for lubricating the pump comprising glycol and glycerine.

121. The diagnostic system of claim 41, further comprising a composition useful for preventing freezing or seizing or stiction of the pump during periods of non-use of the pump, comprising at least one of the following properties:

liquid at the operating temperature;

low vapor pressure;

water soluble;

solvent for residual salts or other solids within the pump dead volume;

low surface tension;

low viscosity;

chemically stable when inside pump or stored in intermediate containers;

does not react with fluids for decontamination;

chemically compatible with exposed materials; and

does not interfere with adjacent operations.

122. A method of preventing freezing or seizing or stiction during periods of non-use of the pump of the diagnostic system of claim 41, comprising:

circulating a composition comprising glycol through the pump of the diagnostic system.

123. The method of claim 122, wherein the composition is stored until use on the cartridge of the diagnostic system that is fluidically connected to the pump of the diagnostic system.

124. The method of claim 123, wherein the composition is returned to the cartridge after it flows through the closed fluidic pathway of the diagnostic system.

125. The method of claim 122, wherein less than about 2.0 nL of the composition is required to protect the pump during periods of non-use.

126. The method of claim 122, wherein less than about 1.5 nL of the composition is required to protect the pump during periods of non-use.

127. The method of claim 122, wherein less than about 1.0 nL of the composition is required to protect the pump during periods of non-use.

128. The method of claim 122, wherein about 1.0 nL of the composition is required to protect the pump during periods of non-use.

129. A method of identifying the cartridge of the diagnostic system of claim 41, comprising:

scanning for a first time a scannable code on the cartridge, wherein the scannable code contains data on at least one of a test protocol for the cartridge, a patient information, a lot number for the cartridge contents, a serial number for the cartridge, an expiration date for the cartridge;

inserting the cartridge into the diagnostic instrument;

scanning for a second time the scannable code on the cartridge while inside the diagnostic instrument;

comparing the data between the scans to ensure that the correct cartridge was inserted into the diagnostic instrument; and

providing feedback to a user on whether the correct cartridge was inserted into the diagnostic instrument.

130. The method of claim 129, wherein the first scan of the scannable code is scanned by an external scannable code scanner.

131. The method of claim 129, wherein the scannable code contains data on all of a test protocol for the cartridge, a patient information, a lot number for the cartridge contents, a serial number for the cartridge, and an expiration date for the cartridge.

132. A method of identifying the cartridge of the diagnostic system of claim 41, comprising:

scanning a scannable code on the cartridge, wherein the scannable code contains data on at least one of a test protocol for the cartridge, a patient information, a lot number for the cartridge contents, a serial number for the cartridge, an expiration date for the cartridge;

inserting the cartridge into the diagnostic instrument;

processing the data from the scanned scannable code to ensure that the correct cartridge was inserted into the diagnostic instrument; and

providing feedback to a user on whether the correct cartridge was inserted into the diagnostic instrument.

133. The method of claim 132, further comprising scanning the scannable code on the cartridge while inside the diagnostic instrument with an internal scanner;

and

comparing the data between the scans to ensure that the correct cartridge was inserted into the diagnostic instrument.

134. The method of claim 132, wherein the first scan of the scannable code is scanned by an external scannable code scanner on the exterior of the diagnostic instrument.

135. A method of preventing reuse of the cartridge of the diagnostic system of claim 41, comprising:

scanning a scannable code on the cartridge with an external scanner, wherein the scannable code contains data on at least one of a record of use, a test protocol for the cartridge, a patient information, a lot number for the cartridge contents, a serial number for the cartridge, an expiration date for the cartridge;

inserting the cartridge into the diagnostic instrument;

scanning the scannable code on the cartridge with an internal scanner once inside the diagnostic instrument;

comparing the data between the scans to identify whether an unused cartridge was inserted into the diagnostic instrument; and

providing feedback to a user on whether the cartridge was previously used by the diagnostic instrument.

136. The method of claim 135, wherein the cartridge is removed from a protective package before scanning by the external scanner.

137. The method of claim 135, wherein the diagnostic instrument will not allow processing the cartridge if the cartridge is a used cartridge.

138. The method of claim 135, wherein the internal scanner scans the cartridge before processing of the cartridge.

139. A method of preventing improper use of the cartridge of the diagnostic system of claim 41, comprising:

scanning a scannable code on a protective package containing the cartridge, wherein the first scan sets a first limit of an expiry time limit predetermined for proper use of the cartridge;

introducing the cartridge into the diagnostic instrument with an internal scanner;

scanning the scannable code on the cartridge with the internal scanner, wherein the internal scan sets a second limit of an expiry not to exceed a predetermined limit for proper use of the cartridge;

calculating the difference between the first and the second time limits;

comparing the difference in time to the predetermine time limit for proper cartridge use; and

providing feedback to user if time limit was breached.

140. A diagnostic system having a closed fluidic pathway, comprising:

a diagnostic instrument comprising;

an internal standard;

a first probe fluidically connected to the internal standard module by at least one fluidic tube;

an electrochemiluminescence (ECL) detection system fluidically connected to the internal standard by the at least one fluidic tube, wherein the ECL detection system comprises;

an ECL detection module comprising;

an enclosure having a top and a base, wherein the surface of the base is flat and capable of forming a working surface, and the top is attached to the base capable of forming the bottom of the enclosure thereby forming a cavity having a height;

a first electrode;

a second electrode; and

a first gasket, wherein the first electrode and the second electrode are stacked and separated by the first gasket, wherein the base supports the first electrode, and wherein the first gasket has a compressible thickness that is capable of creating a predetermined separation gap between the first and second electrodes;

a transparent window formed out of the second electrode to facilitate ECL detection; and

a printed circuit board, wherein the printed circuit board is positioned next to the base of the ECL detection module, electrically connecting components within the ECL detection system;

a pump fluidically connected to the ECL detection system by at least one fluidic tube and fluidically connected to a waste probe by at least one fluidic tube;

a cartridge comprising;

at least one needle;

at least one reservoir;

at least one fluidic seal; and

at least one fluidic channel, wherein the closed fluidic pathway comprises the diagnostic fluidic pathway of the diagnostic instrument; and

the at least one fluidic channel of the cartridge, wherein the closed fluidic pathway begins at the least one needle of the cartridge, passes through the diagnostic instrument, and ends at the at least one reservoir of the cartridge, and is capable of providing fluid from the cartridge to the diagnostic instrument.

141. A diagnostic system having a closed fluidic pathway, comprising:

a diagnostic instrument comprising;

an internal standard;

a first probe fluidically connected to the internal standard module by at least one fluidic tube;

an electrochemiluminescence (ECL) detection system fluidically connected to the internal standard by the at least one fluidic tube, wherein the ECL detection system comprises;

an ECL detection module comprising;

an enclosure having a top and a base, wherein the surface of the base is flat and capable of forming a working surface, and the top is attached to the base capable of forming the bottom of the enclosure thereby forming a cavity having a height;

a first electrode;

a second electrode; and

a first gasket, wherein the first electrode and the second electrode are stacked and separated by the first gasket, wherein the base supports the first electrode and wherein the first gasket has a thickness that is capable of creating a predetermined separation gap between the first and second electrodes;

a transparent window formed out of the second electrode capable of facilitating ECL detection;

a second gasket capable of fluidically sealing the enclosure and capable of having a differential compliance less than the first gasket to maintain the electrode separation gap; and

a printed circuit board positioned next to the base of the ECL detection module, electrically connecting components within the ECL detection system;

a pump fluidically connected to the ECL detection system by at least one fluidic tube and fluidically connected to a waste probe by at least one fluidic tube;

a cartridge comprising;

at least one needle;

at least one reservoir;

at least one fluidic seal; and

at least one fluidic channel, wherein the closed fluidic pathway comprises the diagnostic fluidic pathway of the diagnostic instrument; and

the at least one fluidic channel of the cartridge, wherein the closed fluidic pathway begins at the least one needle of the cartridge, passes through the diagnostic instrument, and ends at the at least one reservoir of the cartridge, and is capable of providing fluid from the cartridge to the diagnostic instrument.

142. A diagnostic system having a closed fluidic pathway, comprising:

a diagnostic instrument comprising;

an internal standard;

a first probe fluidically connected to the internal standard module by at least one fluidic tube;

an electrochemiluminescence (ECL) detection system fluidically connected to the internal standard by the at least one fluidic tube, wherein the ECL detection system comprises;

an ECL detection module comprising;

an enclosure having a top and a base, wherein the surface of the base is flat and capable of forming a working surface, and the top is attached to the base capable of forming the bottom of the enclosure thereby forming a cavity having a height;

a measurement containment area;

a first electrode surface;

a second electrode surface; and

a first gasket cutout, wherein the measurement containment area is formed in part by the first electrode surface, the second electrode surface and the first gasket cutout, and wherein the first electrode and the second electrode are stacked and separated by the first gasket, and

 

wherein the base supports the first electrode, the first gasket has a compressible thickness, and the electrode/gasket stack resides in the cavity capable of creating a predetermined separation gap between the first and second electrode surfaces;

a transparent window in at least one cutout of the second electrode capable of facilitating ECL detection, wherein at least one inlet port and at least one outlet port in the at least one cutout of the second electrode are capable of transporting fluids in and out of the measurement containment area; and

an opaque enclosure surrounding the ECL module capable of exclude ambient light;

a pump fluidically connected to the ECL detection system by at least one fluidic tube and fluidically connected to a waste probe by at least one fluidic tube;

a cartridge comprising;

at least one needle;

at least one reservoir;

at least one fluidic seal; and

at least one fluidic channel, wherein the closed fluidic pathway comprises the diagnostic fluidic pathway of the diagnostic instrument; and

the at least one fluidic channel of the cartridge, wherein the closed fluidic pathway begins at the least one needle of the cartridge, passes through the diagnostic instrument, and ends at the at least one reservoir of the cartridge, and is capable of providing fluid from the cartridge to the diagnostic instrument.

143. The diagnostic system of claim 142, wherein the measurement containment area is capable of being sealed without using adhesives.

144. The diagnostic system of claim 142, wherein the measurement containment area is capable of being sealed using two or more gaskets.

145. The diagnostic system of claim 144, wherein the use of two or more gaskets more compliant than the first gasket the first and second electrode spacing height is capable of being maintained.

146. The diagnostic system of claim 142, wherein when the clamped distortion of the gasket in the unclamped gasket cutouts is compensated for, the measurement containment area is capable of being made precise and accurate.

147. The diagnostic system of claim 142, wherein when the gasket raw material thickness variation in the unclamped gasket cutouts is compensated for, the measurement containment area is capable of being made precise and accurate.

148. The diagnostic system of claim 142, wherein an opaque printed circuit board is capable of blocking ambient light leakage.

149. The diagnostic system of claim 142, wherein an opaque printed circuit board—

with one or more opaque coatings is capable of blocking ambient light leakage.

150. The diagnostic system of claim 142, wherein an opaque printed circuit board with one or more internal or external metal foil layers is capable of blocking ambient light leakage.