Assay Cartridges and Methods of Using the Same

• US 20110201099A1
• Filed: 12/03/2010
• Published: 08/18/2011
• Est. Priority Date: 12/07/2009
• Status: Active Grant

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Lawrence, Noel, Debad, Jeffery, Page, Kenneth, Anderson, Nicholas, Glezer, Eli N., West, Sharon, Sigal, George, Kumar, Sudeep
• Granted Patent: US 10,184,884 B2
• Time in Patent Office: Days
• US Class Current: 435/287.2
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2200/147 Employing temperature sensors
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0874 Three dimensional network
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/126 Paper
• CPC Class Codes: B01L 2300/161 : Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0487 : fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0672 : Swellable plugs
• CPC Class Codes: B01L 2400/0683 : mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/0688 : surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 : characterised by venting arrangements
• CPC Class Codes: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: B01L 3/502784 : specially adapted for droplet or plug flow, e.g. digital microfluidics automatic analysis using a stream of discrete samples in a tube system G01N35/08
• CPC Class Codes: B01L 7/00 : Heating or cooling apparatus autoclaves B01J3/04; Heat insulating devices
• CPC Class Codes: B01L 9/527 : for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: B29C 48/02 : Small extruding apparatus, e.g. handheld, toy or laboratory extruders
• CPC Class Codes: B29C 48/154 : Coating solid articles, i.e. non-hollow articles
• CPC Class Codes: B29C 48/266 : Means for allowing relative movements between the apparatus parts, e.g. for twisting the extruded article or for moving the die along a surface to be coated
• CPC Class Codes: B29C 48/34 : Cross-head annular extrusion nozzles, i.e. for simultaneously receiving moulding material and the preform to be coated
• CPC Class Codes: B29C 48/79 : of preformed parts or layers
• CPC Class Codes: B29C 48/86 : at the nozzle zone
• CPC Class Codes: B29C 48/875 : for achieving a non-uniform temperature distribution, e.g. using barrels having both cooling and heating zones
• CPC Class Codes: B29C 70/504 : using rollers or pressure bands for corrugating B29C53/22
• CPC Class Codes: B29C 70/521 : and impregnating the reinforcement before the die
• CPC Class Codes: B29C 70/526 : Pultrusion dies, e.g. dies with moving or rotating parts B29C70/523 takes precedence
• CPC Class Codes: B29C 70/682 : Preformed parts characterised by their structure, e.g. form
• CPC Class Codes: B29C 70/747 : Applying material, e.g. foam, only in a limited number of places or in a pattern, e.g. to create a decorative effect
• CPC Class Codes: B29C 70/78 : Moulding material on one side only of the preformed part
• CPC Class Codes: B29C 70/86 : Incorporated in coherent impregnated reinforcing layers, e.g. by winding
• CPC Class Codes: G01F 23/02 : by gauge glasses or other apparatus involving a window or transparent tube for directly observing the level to be measured or the level of a liquid column in free communication with the main body of the liquid
• CPC Class Codes: G01F 23/292 : Light , e.g. infrared or ultraviolet
• CPC Class Codes: G01N 1/10 : in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 2021/054 : Bubble trap; Debubbling
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/0303 : Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/05 : Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/13 : Moving of cuvettes or solid samples to or from the investigating station handling materials for automatic analysis G01N35/00
• CPC Class Codes: G01N 21/253 : for batch operation, i.e. multisample apparatus analytical automats G01N35/00
• CPC Class Codes: G01N 21/6452 : Individual samples arranged in a regular 2D-array, e.g. multiwell plates
• CPC Class Codes: G01N 21/69 : specially adapted for fluids , e.g. molten metal
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: Y10T 137/0396 : Involving pressure control
• CPC Class Codes: Y10T 137/8593 : Systems

Abstract

Assay cartridges are described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. In certain embodiments, these cartridges are adapted to receive and analyze a sample collected on an applicator stick. Also described are kits including such cartridges and a cartridge reader configured to analyze an assay conducted using an assay cartridge.

Claims

1. An assay cartridge comprising a sample chamber, a sample indicator window and an optical path from a reflecting surface to said indicator window, wherein said reflecting surface reflects a sample level in said sample chamber to said indicator window.

2. The assay cartridge of claim 1 wherein said sample indicator window comprises an indicating feature.

3. The assay cartridge of claim 2 wherein said indicating feature is an indicating line that indicates a fluid level within said sample chamber, wherein said level is selected, from the group consisting of a sample minimum, a sample maximum, a target level and a combination thereof.

4. The assay cartridge of claim 2 wherein said indicating feature is a boundary of said indicator window.

5. The assay cartridge of claim 1 wherein said reflecting surface is a mirrored surface.

6. The assay cartridge of claim 1 wherein said cartridge comprises a cartridge body and said reflecting surface is provided by total internal reflection at an angled, surface in said cartridge body.

7. The assay cartridge of claim 6 wherein said angled surface is configured such that an angle of incidence along said optical path is greater than a critical angle for total internal reflection at said reflecting surface.

8. The assay cartridge of claim 7 wherein said angled surface is provided by a surface of a cavity within said cartridge body such that light traveling through said cartridge body along said optical path intersects an air-body interface at said cavity surface and is reflected along said optical path to said indicator window.

9. The assay cartridge of claim 1 wherein said cartridge comprises a cartridge top, a cartridge bottom and a cover layer mated to said cartridge bottom and said optical path is provided by said cartridge top.

10. The assay cartridge of claim 1 wherein said sample chamber is connected to an overflow chamber via a sample overflow conduit.

11. The assay cartridge of claim 10 wherein said overflow chamber is connected to a sample vent port via a vent conduit.

12. The assay cartridge of claim 11 wherein said vent conduit is positioned at or near the top of said overflow chamber.

13. The assay cartridge of claim 1 wherein said sample chamber further comprises a sample introduction port comprising a sealable closure including a sealing/capping mechanism comprising (a) a flexible hinge;

(b) a latching mechanism; and

(c) a retention component comprising a retention ring or tab.

14. The assay cartridge of claim 13 wherein said sealing/capping mechanism is a modular detachable insert comprising a cap for sealing said sample chamber.

33. The assay cartridge of claim 1 further comprising a first detection chamber and a second detection chamber.

34. The assay cartridge of claim 33 wherein said first detection chamber is configured for detection and typing of influenza virus.

35. The assay cartridge of claim 34 wherein said first detection chamber comprises a first set of assay reagents including an antibody directed to a target selected from the group consisting of influenza A nucleoprotein, influenza B nucleoprotein, and combinations thereof.

36. The assay cartridge of claim 35 wherein said first set of assay reagents further comprise an antibody directed to an additional target selected from the group consisting of influenza C, adenovirus, parainfluenza, human metapneumovirus, and combinations thereof.

37. The assay cartridge of claim 34 wherein said second detection chamber comprises a second set of assay reagents including antibodies directed to at least two different hemagglutinin (HA) antigen subtypes.

38. The assay cartridge of claim 37 wherein said at least two different HA antigen subtypes are selected from the group consisting of H1, H3, H1 from swine origin influenza virus (SOIV), atypical hemagglutinin subtype, pandemic hemagglutinin subtype, H2, H5, H7, H9, and combinations thereof.

39. The assay cartridge of claim 34 wherein

(i) said first detection chamber comprises a first plurality of working electrodes having said first set of assay reagents immobilized thereon, said first plurality of working electrodes being arranged in a first one-dimensional array within said first detection chamber;

and

(ii) said second detection chamber comprises a second plurality of working electrodes having said second set of assay reagents immobilized thereon, said second plurality of working electrodes being arranged in a second one-dimensional array within said second detection chamber.

40. The assay cartridge of claim 34, wherein said assay cartridge further comprises an additional component selected from the group consisting of an extraction buffer chamber, a wash buffer chamber, and combinations thereof.

41. The assay cartridge of claim 40 wherein said extraction buffer is acidic.

42. The assay cartridge of claim 41 wherein said extraction buffer comprises an additional agent selected from the group consisting of anti-foam agent, a surfactant, and combinations thereof.

43. A kit comprising the assay cartridge of any one of claims 1 and 18.

15. A method of determining a fluid level in an assay cartridge comprising a sample chamber, a sample indicator window, a reflecting surface, and an optical path connecting said sample chamber, said sample indicator window and said reflecting surface, said method comprising the steps of

(a) adding a volume of fluid to said sample chamber, wherein said fluid level effected via said optical path to said indicator window;

(b) viewing said fluid level in said sample indicator window; and

(c) comparing said fluid level relative to an indicating feature on said sample indicator window.

16. The method of claim 15 wherein said indicating feature comprises an indicating line that indicates said fluid level within said sample chamber, wherein said level is selected from the group consisting of a sample minimum, a sample maximum, a target level and a combination thereof.

17. The method of claim 15 wherein said indicating feature comprises a boundary within said indicator window.

18. An assay cartridge for analyzing a sample collected with an applicator stick comprising a shaft and a sample collection head, said cartridge comprising a sample chamber having an elongated cavity that has a first region and a second region, wherein said first and second regions are oriented at an angle with respect to each other and said angle is selected to bend said shaft upon insertion of said applicator stick into said sample chamber and promote fracture of said shaft, and wherein said sample chamber comprises a sample head retention feature.

19. The assay cartridge of claim 18 wherein said retention feature is selected from the group consisting of a barb, a shelf, and combinations thereof.

20. The assay cartridge of claim 18 wherein said retention feature is a barb and said barb is angled to allow for insertion of said shaft into said sample chamber and to prevent removal of said collection head from said sample chamber.

21. The assay cartridge of claim 20 wherein said sample chamber includes a sample collection head extraction location at or near the terminus of said cavity and said barb is positioned in said cavity no as to retain said collection head in said extraction location.

22. The assay cartridge of claim 19 wherein said retention feature is a shelf, wherein said shelf is a stepped discontinuity in an internal surface of said sample chamber.

23. The assay cartridge of claim 22 wherein said sample chamber is curved and the radius of curvature of said internal surface, as a function of increasing depth in said elongated cavity, steps from a first value to a second higher value at said discontinuity.

24. The assay cartridge of claim 19 wherein said sample chamber includes a sample collection head extraction location at or near the terminus of said cavity and said shelf is positioned in said cavity so as to engage a shaft fragment linked to said collection head after said shaft fracture and to retain said collection head in said extraction location.

25. The assay cartridge of claim 19 wherein said second region comprises an integrated filter element, and said assay cartridge further comprises an extraction buffer chamber connected to an extraction buffer vent port and an extraction buffer conduit connected to said sample chamber, wherein said sample chamber is connected to a collection chamber via a sample chamber conduit.

26. The assay cartridge of claim 25 wherein said extraction buffer conduit comprises a Z-transition.

27. The assay cartridge of claim 25 wherein said sample chamber comprises a sample introduction port and said first region is proximate to said sample introduction port and said second region is distal to said sample introduction port.

28. The assay cartridge of claim 27 wherein said sample chamber has an internal terminus and said integrated filter element is positioned at or near said terminus.

29. The assay cartridge of claim 25 wherein said extraction buffer conduit is positioned at or near said terminus.

30. The assay cartridge of claim 19 wherein said collection component comprises a collection chamber and a sensing chamber, wherein said collection chamber is connected to

(i) an input conduit connected to the top of said collection chamber, wherein said input conduit is positioned proximal to a wall of said collection chamber;

(ii) an output conduit connected to the bottom of said collection chamber; and

(iii) a sensing conduit comprising a tube that extends down from the top of said collection chamber to a pre-defined height in said collection chamber, wherein said sensing chamber connects to said sensing conduit at the top of said sensing chamber and proximal to a wall of said sensing chamber and to a sensing chamber vent.

31. The assay cartridge of claim 30 wherein said collection component further comprises a baffle positioned at the top of said collection chamber and adjacent to said input conduit.

32. The assay cartridge of claim 30 wherein said collection component further comprises an optical sensor adapted to detect the presence of liquid in said sensing chamber.

44. An assay cartridge comprising a cartridge body including a reagent chamber adapted to receive a cylindrical ampoule, wherein said reagent chamber comprises side walls and a plurality of support brackets protruding from said side walls, wherein said support brackets are configured to provide a multi-point cradle support for said cylindrical ampoule.

45. The assay cartridge of claim 44 wherein said side walls are sloped such that the width of said reagent chamber at the base of said reagent chamber is narrow relative to the width of said reagent chamber at the top of said reagent chamber.

46. The assay cartridge of claim 44 wherein said plurality of support brackets are sloped inward such that the width of the width of the cradle support is narrower at the bottom of the reagent chamber than at the top.

47. An assay cartridge comprising a sample chamber connected to a collection component via a collection conduit, said collection component comprising a collection chamber and a sensing chamber, wherein said collection chamber is connected to

(i) said collection conduit, wherein said collection conduit is connected to the top of said collection chamber and is positioned proximal to a wall of said collection chamber

(ii) an output conduit connected to the bottom of said collection chamber;

and

(iii) a sensing conduit comprising a tube that extends down from the top of said collection chamber to a pre-defined height in said collection chamber, wherein said sensing chamber connects to said sensing conduit at the top of said sensing chamber and proximal to a wall of said sensing chamber and said sensing chamber also connects to a sensing chamber vent.

48. The assay cartridge of claim 47 wherein said collection chamber further comprises a baffle positioned at the top of said collection chamber, adjacent to said collection conduit and between said collection and sensing conduits.

49. The assay cartridge of claim 47 wherein said collection component further comprises an optical sensor adapted to detect the presence of liquid in said sensing chamber.

53. The assay cartridge of claim 47 further comprising a detection chamber and a distribution conduit interconnected to a plurality of fluid conduits comprising said outlet conduit, a detection chamber conduit connected to said detection chamber and, optionally, one or more fluid conduits connected to one or more cartridge components selected from the group consisting of a wash buffer chamber, an air vent, a waste chamber, and combinations thereof.

54. The assay cartridge of claim 53 wherein a connection between said distribution conduit and one of said plurality of fluid conduits comprises a Z-transition.

55. The assay cartridge of claim 54 wherein said cartridge comprises an air vent and said one or more fluid conduits include an air vent conduit connected to said air vent, wherein said detection chamber conduit is distal from said air vent conduit.

56. The assay cartridge of claim 55 wherein said cartridge comprises said wash buffer chamber and said one or more fluid conduits comprise a wash buffer chamber conduit connected to said wash buffer chamber, wherein said wash buffer chamber conduit is proximal to said air vent conduit and distal to said detection chamber conduit.

57. A fluid flow path comprising:

(a) a first resistance region;

(b) a connecting region proximal to said first resistance region; and

(c) a matching resistance region proximal to said connecting region and distal to said first resistance region, wherein the hydrodynamic resistance of said matching resistance region is substantially equivalent to the hydrodynamic resistance of said first resistance region and is substantially greater than the hydrodynamic resistance of said connecting region.

58. The fluid flow path of claim 57 wherein said flow path further comprises an additional region selected from the group consisting of:

(d) an inlet region proximal to said first resistance region and distal to said connecting region;

(e) an outlet region proximal to said matching resistance region and distal to said connecting region; and

(f) combinations thereof.

59. The fluid flow path of claim 57 wherein said connecting region is provided in the same plane as the first resistance region.

60. The fluid flow path of claim 57 wherein said connecting region is provided in a different plane relative to said first resistance region and said matching resistance region.

61. The fluid flow path of claim 60 wherein said connecting region provides a Z-transition between said first resistance region and said matching resistance region.

62. The fluid flow path of claim 57 wherein said connecting region is positioned at an exit orifice of said first resistance region.

63. The fluid flow path of claim 57 wherein said matching resistance region is positioned at an exit orifice of said connecting region.

64. A fluidic network comprising the fluid flow path of claim 57.

65. The fluidic network of claim 64 wherein said fluidic network further comprises a metering component linked to said fluid flow path and configured to meter a fluid slug through said first resistance region, said connecting region and said matching resistance region.

66. The fluidic network of claim 65 wherein a metered volume is approximately equal to the sum of the volumes of said first resistance region and said connecting regions.

67. The fluid flow path of claim 57 wherein said first resistance region comprises a fan region.

68. The fluid flow path of claim 67 wherein said first resistance region is a high aspect ratio flow cell.

69. The fluid flow path of claim 68 wherein said first resistance region is configured as a detection chamber.

70. The fluid flow path of claim 57 wherein said first resistance region is about 5 mils×

120 mils and said matching resistance region is about 10 mil×

80 mil.

71. The fluid flow path of claim 57 wherein the height of said first resistance region is about half the height of said matching resistance region.

72. The fluid flow path of claim 58 wherein said inlet region comprises a throw region and said inlet region is positioned between two sensing sites;

wherein the volume of said connecting region is greater than or equal to the volume of said throw region.

73. An assay cartridge comprising a fluidic network of claim 57.

74. A method for moving fluid in a fluidic network comprising:

(a) introducing a fluid slug into a hydrodynamic resistance matched fluid flow path within said fluidic network;

wherein said flow path comprises the following components;

(i) a first resistance region;

(ii) a connecting region proximal to said first resistance region; and

(iii) a matching resistance region proximal to said connecting region and distal to said first resistance region; and

(b) using air pressure to move said fluid slug through said flow path.

75. The method of claim 74 wherein said flow path is configured such that

(i) the hydrodynamic resistance of said matching resistance region is substantially equivalent to the hydrodynamic resistance of said first resistance region and is substantially greater than the hydrodynamic resistance of the connection region;

and

(ii) the volume of said fluid slug is greater than the volume of said first resistance region and less than the combined volume of said first resistance region, said connecting region and said matching resistance region.

76. A cartridge reader configured to analyze an assay conducted in an assay cartridge, said cartridge reader comprising

(a) an enclosure;

(b) a cartridge tray for holding a cartridge during analysis in the cartridge reader;

(c) a rail in said enclosure, wherein said cartridge tray is mounted on said rail such that said tray can move in and out of said enclosure by moving along said rail;

(d) an actuator to move said cartridge tray along said rail;

(e) a mounting frame in said enclosure, said mounting frame is configured to align said cartridge with one or more reader components; and

(f) an alignment guide attached to said cartridge tray that is configured to engage with and control movement of said mounting frame.

50. A method of collecting a liquid in the assay cartridge of claim 88, said method comprising

(i) introducing liquid, into said collection chamber via said collection conduit until a liquid level reaches said pre-defined height in said collection chamber;

(ii) introducing additional liquid into said collection chamber via said collection conduit such that said, additional liquid is transferred through said sensing conduit into said sensing chamber;

(iii) detecting liquid in said sensing chamber via said optical sensor; and

(iv) transferring liquid from said collection chamber through said outlet conduit.

51. The method of claim 50, wherein said liquid, introduced into said collection chamber contains bubbles and said liquid transferred through said outlet conduit is substantially free of bubbles.

52. The method of claim 50 wherein said collection chamber further comprises a baffle positioned at the top of said collection chamber and adjacent to said input conduit, and said method further comprises contacting said liquid with said baffle and said wall of said collection chamber to constrain bubbles within said liquid.

77. The cartridge reader of claim 76 wherein said assay cartridge comprises a flow cell having a sample chamber, a detection chamber and an outlet, wherein said sample chamber, said detection chamber, and said outlet define a flow path through said flow cell, said detection chamber comprising a plurality of electrodes.

78. The cartridge reader of claim 76 wherein said actuator comprises a motor and a lead screw cooperating with a lead screw nut affixed to said cartridge tray, wherein said motor is configured to turn said lead screw to translate said lead screw nut, to move said cartridge tray along said rail.

79. The cartridge reader of claim 76 wherein said enclosure is a light-tight enclosure and said enclosure further comprises a door to seal said light-tight enclosure.

80. The cartridge reader of claim 76 wherein said one or more reader components includes said ampoule breaking mechanism and said ampoule breaking mechanism is affixed to said mounting frame.

81. The cartridge reader of claim 76 wherein said one or more reader components includes said electrode contact pin assembly and said electrode contact pin assembly is affixed to said mounting frame and supports conductive pins configured to make electrical contact to said plurality of electrodes on said assay cartridge.

82. The cartridge reader of claim 76 wherein said one or more reader components includes said fluidic manifold and said fluidic manifold is affixed to said mounting frame and comprises an additional element selected from the group consisting of fluidic connectors to mate with a vent port in said assay cartridge, an air cylinder pump, a plurality of valves, and combinations thereof.

83. The cartridge reader of claim 76 wherein

(a) said alignment guide comprises a vertical tab;

(b) said mounting frame comprises an engagement pin and rollers, and

(c) said enclosure further comprises tracks on each side of said mounting frame, wherein said rollers are received by said tracks and said vertical tab contacts said engagement pin during movement of the cartridge tray, causing said mounting frame to translate along said tracks in coordination with said cartridge tray.

84. The cartridge reader of claim 83 wherein said tracks comprise at least one downward sloping region and a fiat region, and

(i) movement within said sloping region causes said mounting frame to be lowered relative to said cartridge tray for cartridge processing;

and

(ii) movement within the flat region causes said mounting frame to move along with said cartridge tray while remaining in vertical and horizontal alignment for cartridge processing.

85. The cartridge reader of claim 83, wherein when the rollers move within the downward sloping regions, the engagement pin is received in a notch defined on the alignment guide.

86. The cartridge reader of claim 83 wherein said mounting frame comprises two rollers on each side of said mounting frame and said rollers are each received in tracks.

87. The cartridge reader of claim 83 wherein said alignment guide comprises a notch adjacent to said vertical tab and configured to receive said pin, said pin engaging said notch to releasably hold said mounting frame into horizontal alignment.

88. The cartridge reader of claim 83 wherein said cartridge tray comprises vertical guides configured to engage said mounting frame, wherein said vertical guides define the vertical height of said mounting frame relative to said cartridge tray.

89. The cartridge reader of claim 83 wherein said track further comprises an elevated shelf region on which said rollers rest when said mounting frame is not engaged by said alignment guide, wherein said elevated shelf region is connected to the downward sloping region.

90. The cartridge reader of claim 89 wherein said elevated shelf region is connected to said downward sloping region at the apex of said downward sloping region.

91. The cartridge reader of claim 83 wherein said cartridge tray comprises a locking mechanism.

92. The cartridge reader of claim 91 wherein said assay cartridge comprises a skirt and said cartridge tray comprises a slot sized to receive said skirt.

93. The cartridge reader of claim 91 wherein said locking mechanism comprises a spring loaded rotating latch, a first pin configured to engage with said assay cartridge, a second pin configured to engage with a notch on said assay cartridge, wherein movement of said assay cartridge onto said cartridge tray contacts said first pin causing said latch to rotate and said second pin to engage with said notch.

94. The cartridge reader of claim 93 wherein said spring loaded rotating latch comprises a spring to resist the rotation of said latch.

95. The cartridge reader of claim 94 wherein said resistance of spring is reduced as said second pin engages with said notch.

96. The cartridge reader of claim 95 wherein said latch further comprises a tab and said locking mechanism further comprises an optical sensor, wherein said tab is configured to cover said optical sensor when said locking mechanism is engaged.

97. The cartridge reader of claim 96 wherein said tab comprises a pin extending down toward said optical sensor.

98. The cartridge reader of claim 83, wherein said one or more reader components comprise a photodiode assembly and said photodiode assembly comprises a traveler block including positioning pins extending from said traveler block, said positioning pins being configured to couple motion of said mounting frame to the lateral motion of said traveler block.

99. The cartridge reader of claim 98 wherein said photodiode assembly further comprising an alignment component to align a photodiode with a region on said assay cartridge.

100. The cartridge reader of claim 99 wherein said photodiode is mated to an optical coupler.

101. The cartridge reader of claim 99 wherein said photodiode is mated to a light guide.

102. The cartridge reader of claim 100 wherein said optical coupler is surrounded by a conductive shield.

103. The cartridge reader of claim 98 wherein said photodiode is mounted to said traveler block, said traveler block being configured to move side-to-side along at least one guide cylinder mounted in said photodiode assembly.

104. The cartridge reader of claim 83 wherein said traveler block is spring loaded and is movable when a force sufficient to overcome the spring force is applied.

105. The cartridge reader of claim 83 wherein said cartridge reader is configured to analyze an assay conducted in an assay cartridge comprising an ampoule, said cartridge reader comprising an ampoule breaking mechanism comprising a hammer element.

106. The cartridge reader of claim 105 wherein said hammer element is coupled to an active drive element selected, from the group consisting of a motor, a solenoid, and a spring.

107. The cartridge reader of claim 105 wherein said hammer element is coupled to a spring and said hammer is held under a spring force.

108. The cartridge reader of claim 105 wherein said hammer element comprises a lever arm including a striking face.

109. The cartridge reader of claim 108 wherein said striking face is a protruding striking face.

110. The cartridge reader of claim 105 wherein said striking face is pointed.

111. The cartridge reader of claim 105 wherein said hammer element is configured to be raised and lowered relative to said assay cartridge by rotation of said hammer element around a hammer axle.

112. The cartridge reader of claim 105 wherein said hammer element further comprises a control surface in coordination with a cam affixed to a rotating control axle, wherein the rotation of said control axle raises and lowers said striking face relative to said assay cartridge.

113. The cartridge reader of claim 112 wherein said cam comprises a mechanical stop positioned on a surface of said cam.

114. The cartridge reader of claim 113 wherein said cam is in coordination with a mechanical step positioned on an additional element of said ampoule breaking mechanism.

115. The cartridge reader of claim 105 wherein said assay cartridge comprises two ampoules and said ampoule breaking mechanism is configured to break said two ampoules serially or in parallel.

116. The cartridge reader of claim 115 wherein said ampoule breaking mechanism comprises a plurality of ampoule release mechanisms.

117. The cartridge reader of claim 116 wherein an active drive element controls a plurality of hammer elements.

118. The cartridge reader of claim 116 wherein said ampoule breaking mechanism comprises a first ampoule release mechanism and a second ampoule release mechanism, wherein said first ampoule release mechanism comprises a first hammer element in coordination with a first cam on a control axle and said second ampoule release mechanism comprises a second hammer element in coordination with a second cam on said control axle.

119. The cartridge reader of claim 118 wherein said first and second cams are located in different relative rotational positions in said ampoule breaking mechanism, and said first and second cams are configured to engage said first and second hammer elements at different times during the rotation of said control axle.

120. The cartridge reader of claim 118 wherein said first and second cams are located in approximately the same relative rotational positions in said ampoule breaking mechanism, and said first and second cams are configured to engage said first and second hammer elements at approximately the same time during the rotation of said control axle.