Analytical systems, devices, and cartridges therefor

• US 20050249633A1
• Filed: 05/05/2004
• Published: 11/10/2005
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Omniquant Medical, Inc.
• Inventors: Blatt, Joel M., Stivers, Carole R.
• Granted Patent: US 7,887,750 B2
• Time in Patent Office: Days
• US Class Current: 422/56
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• 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: 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 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/0009 General constructional details of gas analysers, e.g. portable test equipment G01N1/22 takes precedence
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: G01N 35/0099 comprising robots or similar manipulators robots per se B25J
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

Described here are systems, devices, cartridges, methods, and kits for detecting or quantifying at least two different analytes using at least two different techniques, in a single sample. The cartridges typically comprise at least two test sites and the location of at least one test site is not dependent on a corresponding measurement device. The systems generally comprise a device, memory, and a processing module. The device comprises a light source, an array detector, and a port configured to accept at least a portion of a cartridge. The processing module is configured to perform an image analysis of the cartridge. The methods comprise the steps of acquiring calibration information, acquiring an image of the cartridge, performing an image analysis, and cycling through specific detection or quantification techniques corresponding to the techniques required by the test sites. Computer readable media are also described.

Claims

1. A cartridge comprising at least two test sites having at least two test site read zones for the detection or quantification of at least two different analytes and configured to use at least two different techniques for the detection or quantification of the at least two different analytes, wherein the location of at least one of the at least two test site read zones is not dependent on a corresponding measurement device.

2. The cartridge of claim 1 wherein the at least two different analytes are structurally and chemically the same, but have different concentrations.

3. The cartridge of claim 1 wherein the techniques are independently selected from the group consisting of enzyme assays, specific binding assays, immunoassays, nucleic acid hybridization assays, fluorescence labeling, chemiluminescent labeling, electrochemiluminescent labeling, fluorescence measurement, chemiluminescent measurement, electrochemiluminescent measurement, reflectance measurement, transmittance measurement, absorbance measurement, turbidity measurement, electrochemistry, and combinations thereof.

4. The cartridge of claim 1 comprising at least three test site read zones.

5. The cartridge of claim 1 comprising at least six test site read zones.

6. The cartridge of claim 1 wherein at least one test site is configured to detect or quantify an analyte that is treatment, disease, disorder, or ailment specific.

7. The cartridge of claim 1 wherein at least one test site is configured to detect or quantify an analyte that is a substance of abuse.

8. The cartridge of claim 1 wherein at least one test site is configured to detect or quantify an analyte that is a medicament or a by-product thereof.

9. The cartridge of claim 1 wherein at least one test site is configured to detect or quantify an analyte that is an environmental toxin or contaminant.

10. The cartridge of claim 1 wherein at least one test site is configured to detect or quantify an analyte that is a biological or chemical warfare agent.

11. The cartridge of claim 1 wherein the at least two test sites are of different heights.

12. The cartridge of claim 1 further comprising a unique identifier tag.

13. The cartridge of claim 12 wherein the unique identifier tag is selected from the group consisting of a bar code, a mechanical pattern, a microchip, and a printed pattern.

14. The cartridge of claim 1 wherein the cartridge is housed in a sealed, but openable moisture resistant package.

15. The cartridge of claim 1 configured to accept a sample volume of about 20 μ

L or less.

16. The cartridge of claim 1 configured to accept a sample of bodily fluid.

17. The cartridge of claim 16 wherein the bodily fluid is selected from the group consisting of whole blood, plasma, serum, sweat, saliva, tears, interstitial fluid, spinal fluid, ocular fluid, pus, milk, semen, amniotic fluid, vaginal secretions, mucous secretions, and urine.

18. A cartridge comprising:

a bottom layer, wherein, at least a portion of the bottom layer is non-porous;

a sample distribution layer; and

at least two test sites having at least two test site read zones;

wherein the test sites are adjacent to or embedded within the sample distribution layer and configured to detect at least two analytes using two different techniques, and

wherein the location of at least one of the at least two test site read zones is not dependent on a corresponding measurement device.

19. The cartridge of claim 18 wherein the at least two different analytes are structurally and chemically the same, but have different concentrations.

20. The cartridge of claim 18 wherein at least a portion of the sample distribution layer is made of a porous material.

21. The cartridge of claim 18 wherein the sample distribution layer is an open channel capillary layer.

22. The cartridge of claim 18 further comprising a red blood cell separating layer.

23. The cartridge of claim 18 further comprising a retaining layer, wherein the retaining layer is configured to adhere together the bottom layer, the sample distribution layer, and the test sites.

24. The cartridge of claim 18 comprising at least three test site read zones.

25. The cartridge of claim 18 comprising at least six test site read zones.

26. The cartridge of claim 18 wherein at least one test site is configured to detect or quantify an analyte that is treatment, disease, disorder, or ailment specific.

27. The cartridge of claim 18 wherein at least one test site is configured to detect or quantify an analyte that is a substance of abuse.

28. The cartridge of claim 18 wherein at least one test site is configured to detect or quantify an analyte that is a medicament or a by-product thereof.

29. The cartridge of claim 18 wherein at least one test site is configured to detect or quantify an analyte that is an environmental toxin or contaminant.

30. The cartridge of claim 18 wherein at least one test site is configured to detect or quantify an analyte that is a biological or chemical warfare agent.

31. The cartridge of claim 18 wherein the at least two test sites are of different heights.

32. The cartridge of claim 18 further comprising a unique identifier tag.

33. The cartridge of claim 32 wherein the unique identifier tag is selected from the group consisting of a bar code, a mechanical pattern, a microchip, and a printed pattern.

34. The cartridge of claim 18 wherein the cartridge is housed in a sealed, but openable moisture resistant package.

35. The cartridge of claim 18 configured to accept a sample volume of about 20 μ

L or less.

36. The cartridge of claim 18 configured to accept a sample of bodily fluid.

37. The cartridge of claim 36 wherein the bodily fluid is selected from the group consisting of whole blood, plasma, serum, sweat, saliva, tears, interstitial fluid, spinal fluid, ocular fluid, pus, milk, semen, amniotic fluid, vaginal secretions, mucous secretions, and urine.

38. A system for detecting or quantifying at least two different analytes comprising:

a device, wherein the device comprises

a port configured to accept at least a portion of a cartridge, the cartridge having at least two test site read zones and the portion having at least one test site read zone,

a light source, and

an array detector;

memory; and

a processing module configured to receive signals from the array detector and to perform an image analysis of the cartridge to identify the location of at least one of the test site read zones,

wherein the system enables the detection or quantification of the at least two analytes using at least two different detection or quantification techniques.

39. The system of claim 38 wherein the techniques are independently selected from the group consisting of enzyme assays, specific binding assays, immunoassays, nucleic acid hybridization assays, fluorescence labeling, chemiluminescent labeling, electrochemiluminescent labeling, fluorescence measurement, chemiluminescent measurement, electrochemiluminescent measurement, reflectance measurement, transmittance measurement, absorbance measurement, turbidity measurement, electrochemistry, and combinations thereof.

40. The system of claim 38 wherein the processing module is configured to determine an error condition.

41. The system of claim 40 wherein the error condition is selected from the group consisting of an expired cartridge, an inadequate sample volume, an impossible analyte value, a reagent malfunction, a mechanical malfunction, an electronic malfunction, and mixtures thereof.

42. The system of claim 38 further comprising a server connection line.

43. The system of claim 38 wherein the processing module is automatically upgradeable.

44. The system of claim 38 configured to read a unique identifier tag on the cartridge.

45. The system of claim 38 wherein the system is self-calibrating.

46. The system of claim 38 further comprising non-volatile memory.

47. The system of claim 38 further comprising a computer.

48. A kit for detecting or quantifying at least two different analytes comprising:

the system of claim 38;

and

a cartridge having test sites, the test sites further having test site read zones.

49. The kit of claim 48 wherein at least a portion of the cartridge is configured to protrude from the port of the device.

50. The kit of claim 49 wherein the protruding portion comprises a red blood cell separator.

51. The kit of claim 48 wherein the cartridge is disposable.

52. A device for detecting or quantifying at least two different analytes comprising:

a port configured to accept at least a portion of a cartridge, the cartridge having at least two test site read zones and the portion thereof having at least one test site read zone;

a light source;

an array detector;

memory; and

a processing module configured to receive signals from the array detector and to perform an image analysis of the cartridge to identify the location of at least one of the test site read zones,

wherein the device enables the detection or quantification of the at least two analytes using at least two different detection or quantification techniques.

53. The device of claim 52 further comprising polarization optics.

54. The device of claim 52 wherein the light source comprises at least one LED.

55. The device of claim 52 wherein the light source comprises an incandescent lamp.

56. The device of claim 52 wherein the array detector comprises CCD or CMOS technology.

57. The device of claim 52 wherein the device occupies no more than about 1 cubic foot of volume.

58. The device of claim 52 wherein the techniques are independently selected from the group consisting of enzyme assays, specific binding assays, immunoassays, nucleic acid hybridization assays, fluorescence labeling, chemiluminescent labeling, electrochemiluminescent labeling, fluorescence measurement, chemiluminescent measurement, electrochemiluminescent measurement, reflectance measurement, transmittance measurement, absorbance measurement, turbidity measurement, electrochemistry, and combinations thereof.

59. The device of claim 52 wherein the processing module is configured to determine an error condition.

60. The device of claim 59 wherein the error condition is selected from the group consisting of an expired cartridge, an inadequate sample volume, an impossible analyte value, a reagent malfunction, a mechanical malfunction, an electronic malfunction, and mixtures thereof.

61. The device of claim 52 configured to read a unique identifier tag on the cartridge.

62. The device of claim 52 further comprising a back-up power source.

63. The device of claim 52 further comprising non-volatile memory.

64. A computer readable medium containing code for performing an image analysis of a cartridge comprising at least two test site read zones for the detection or quantification of at least two different analytes and configured to use at least two different techniques for the detection or quantification of the at least two different analytes, wherein the image analysis identifies the location of at least one of the test site read zones.

65. The computer readable medium of claim 64, wherein the computer readable medium is firmware.

66. The computer readable medium of claim 64, wherein the computer readable medium is software.

67. A method for detecting or quantifying at least two different analytes on a single cartridge using at least two different detection or quantification techniques comprising the steps of:

acquiring calibration information for a cartridge having at least two test site read zones;

acquiring an image of the cartridge using an array detector;

performing an image analysis of the cartridge to identify the location of at least one of the test site read zones; and

cycling through specific detection or quantification techniques corresponding to the detection or quantification techniques required by the test site read zones, wherein at least two different techniques are used.

68. A device for detecting or quantifying analytes comprising:

a port configured to accept at least a portion of a cartridge, the portion having at least one test site read zone; and

a processing module, wherein the processing module is automatically upgradeable.

69. The device of claim 68, wherein the processing module is automatically upgradeable from a remote source.

70. The device of claim 69, wherein the remote source is accessible via a telephone data connection.

71. The device of claim 69, wherein the remote source is accessible via an internet connection.

72. The device of claim 69, wherein the processing module automatically obtains lot-specific calibration information from a remote source.

73. The device of claim 69, wherein the processing module automatically obtains lot-specific expiration information from a remote source.

74. The device of claim 69, wherein the processing module automatically obtains software algorithms from a remote source.

75. The device of claim 69, wherein the processing module automatically receives notification from a remote source regarding maintenance, repair, or mechanical upgrading.

76. A method for detecting or quantifying at least one analyte comprising the steps of:

providing a device comprising a port configured to accept at least a portion of a cartridge, the portion having at least one test site read zone, and a processing module, wherein the processing module is automatically upgradeable;

allowing the processing module to be automatically upgraded; and

using the upgraded processing module to calculate at least one test result.