System for Conducting the Identification of Bacteria in Urine

• US 20110008825A1
• Filed: 10/10/2008
• Published: 01/13/2011
• Est. Priority Date: 10/10/2007
• Status: Active Grant

• Current Assignee: Pocared Diagnostics Ltd.
• Original Assignee: Pocared Diagnostics Ltd.
• Inventors: Barnes, Russell H., Scott, K. Bryan, Boyd, Douglas E., Stillman, Carol, Dennis, Joseph D., Gurfinkel, Jonathan, Huckaby, Steven E., Sadeski, Kevin, Holley, Dave, Ingber, Gal, Talbert, Sherwood, Tallarico, John, Atterbury, William G., Klausing, Thomas A., Schaefer, Jason A., Laudo, John S.
• Granted Patent: US 8,808,649 B2
• Time in Patent Office: Days
• US Class Current: 435/39
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: G01N 2021/6482 Sample cells, cuvettes
• CPC Class Codes: G01N 2035/0436 with pre-packaged reagents, i.e. test-packs
• CPC Class Codes: G01N 2035/0444 for cuvettes or reaction vessels
• CPC Class Codes: G01N 2035/0448 composed of interchangeable ring elements
• CPC Class Codes: G01N 2035/0458 Multiple concentric rows of wells
• 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 2201/0415 Carrusel, sequential
• CPC Class Codes: G01N 33/493 urine
• CPC Class Codes: G01N 35/025 having a carousel or turntable for reaction cells or cuvettes
• CPC Class Codes: G01N 35/04 Details of the conveyor system G01N35/021 - G01N35/028 take precedence

Abstract

A system for conducting the identification and quantification of micro-organisms, e.g., bacteria in urine samples which includes: 1) several disposable cartridges for holding four disposable components including a centrifuge tube, a pipette tip having a 1 ml volume, a second pipette tip having a 0.5 ml volume, and an optical cup or cuvette; 2) a sample processor for receiving the disposable cartridges and processing the urine samples including transferring the processed urine sample to the optical cups; and 3) an optical analyzer for receiving the disposable cartridges and configured to analyze the type and quantity of micro-organisms in the urine sample. The disposable cartridges with their components including the optical cups or cuvettes are used in the sample processor, and the optical cups or cuvettes containing the processed urine samples are used in the optical analyzer for identifying and quantifying the type of micro-organism existing in the processed urine samples.

Claims

1. A disposable cartridge for use in the identification and quantification of micro-organisms in a fluid sample, comprising:

a cassette body;

a tube for an unprocessed fluid sample;

a plurality of disposable components including a centrifuge tube received by the cassette body;

a removable pipette tip;

an optical cup or cuvette containing the processed fluid sample for use in an optical analysis; and

the optical cup or cuvette having a tapered end into which a light source travels for the optical analysis of the processed urine sample and a reflective surface for enhancing the optical analysis.

2. The cartridge of claim 1, further comprising a second pipette tip.

3. The cartridge of claim 1, wherein the pipette tip has a volume of 1.0 ml.

4. The cartridge of claim 2, wherein the second pipette tip has a volume of 0.5 ml.

5. The cartridge of claim 1, wherein the fluid sample is urine.

6. The cartridge of claim 1, wherein the pipette tip is secured within the disposable cartridge.

7. The cartridge of claim 1, wherein the light source is ultra violet (UV) light.

8. The cartridge of claim 1, wherein the cassette body is bar coded.

46. The system of claim 1, wherein the pipette tip is secured within the disposable cartridge.

9. An optical cup or cuvette for holding a processed fluid sample and for use in an optical analysis, comprising:

a container having a tapered end into which a light source travels for the optical analysis of the fluid sample and a reflective surface for enhancing the optical analysis.

10. The optical cup or cuvette of claim 9, wherein the fluid sample is urine.

11. The optical cup or cuvette of claim 9, wherein the light source is ultra violet (UV) light.

12. The optical cup or cuvette of claim 9, wherein the container is made of a material selected from the group consisting of plastic, glass and aluminum and wherein the reflective surface is selected from the group consisting of a coating or a layer of material.

13. The optical cup or cuvette of claim 9, wherein the reflective

surface is an inner reflective

surface of the container.

14. The optical cup or cuvette of claim 9, wherein the container is made of a disposable material.

15. A sample processor for preparing fluid samples used for conducting the identification and quantification of micro-organisms in the urine samples, comprising:

a) a rotatable table; and

b) a magazine supported by the rotatable table adapted to contain cartridges and containing a plurality of cartridges for holding a plurality of disposable components including a centrifuge tube and an optical cup or cuvette.

16. The sample processor of claim 15, further comprising a second pipette tip.

17. The sample processor of claim 15, wherein the pipette tip has a volume of 1.0 ml.

18. The sample processor of claim 16, wherein the second pipette tip has a volume of 0.5 ml.

19. The sample processor of claim 15, wherein the fluid sample is urine.

20. The sample processor of claim 15, further comprising a centrifuge for receiving the centrifuge tube of the plurality of cartridges for centrifuging the urine sample therein.

21. The sample processor of claim 15, further comprising a rotatable gripper mechanism for transferring each centrifuge tube from the magazine to the centrifuge and back.

22. The sample processor of claim 16, further comprising a movable fluid transfer arm for diluting the dissolved material in the fluid samples by using the pipette and for transferring the diluted fluid urine to the optical cup or cuvette of each cartridge by using the second pipette tip.

23. The sample processor of claim 15, further comprising a syringe pump dispenser fluid system for delivering clean fluid to the fluid samples for the dilution of the dissolved materials in the fluid samples.

24. The sample processor of claim 15, wherein the fluid sample is urine.

25. A method for processing a fluid sample in preparation for the identification and quantification of micro-organisms in the fluid sample, the steps comprising:

a) obtaining a fluid sample;

b) passing the fluid sample through a filter;

c) obtaining a sample of the filtered fluid sample and placing it into a centrifuge tube;

d) obtaining a dilution of the dissolved material in the fluid sample while retaining bacteria in the fluid sample by performing the following steps;

1) centrifuging the sample of step c);

2) decanting a portion of the fluid in the centrifuge tube of step

     1);

3) replacing the decanted solution of step

     2) with a saline solution; and

e) transferring the final solution of step

     4) into an optical cup or cuvette for analysis.

26. The method of claim 25, wherein the fluid sample is urine.

27. The method of claim 25, wherein step d) results in about a 1,000,000:

1 dilution.

28. The method of claim 25, wherein the sample of step (d)(1) is centrifuged at about 12,000 g-forces.

29. The method of claim 25 wherein about 95% of the fluid from step (d)(2) is decanted.

59. The method of claim 25 wherein after step d(3), further comprising a step of repeating steps (1), (2) and (3) and then transferring the final solution into an optical cup or cuvette for analysis.

60. The method of claim 25 wherein after step (d)(3), further comprising a step of repeating steps (1), (2) and (3) for a plurality of times and then transferring the final solution into an optical cup or cuvette for analysis.

61. The method of claim 60, wherein the plurality of times is at least five times.

30. An optical analyzer for analyzing fluid samples, comprising:

a) a drawer having a rotatable table and a magazine supported by the rotatable table and adapted to contain a plurality of cartridges with cups or cuvettes, each containing a fluid sample; and

b) an optics system for analyzing each fluid sample.

31. The optical analyzer of claim 30, further comprising a bar code reader station.

32. The optical analyzer of claim 30, further comprising a thermal control located under the rotatable table and configured to decrease and maintain the temperature of each fluid sample to slow the metabolism of the bacteria while increasing the fluorescence signal.

33. The optical analyzer of claim 30, further comprising an infrared temperature sensor for detecting and monitoring the temperature of each fluid sample.

34. The optical analyzer of claim 31, further comprising a drive mechanism for automatically rotating and registering the rotatable table and the plurality of cartridge with cups or cuvettes in position relative to the bar code reader station and the optics system.

35. The optical analyzer of claim 30, further comprising a first mechanical locking system for maintaining the drawer in position relative to the optics system.

36. The optical analyzer of claim 30, further comprising a second mechanical locking system for maintaining each cup or cuvette in position relative to the optics system.

37. The optical analyzer of claim 30, wherein the optics system is comprised of an excitation module unit, an optical collection unit and a spectrometer.

38. The optical analyzer of claim 37, wherein the excitation module unit includes a plurality of LED modules for sequentially providing excitation signals to each liquid sample at a plurality of different excitation wavelengths,

wherein the optical collection unit is a CCD photon detector;

and

wherein the spectrometer is a Czerny-Turner spectrometer.

39. The optical analyzer of claim 37, wherein the spectrometer includes an entrance slit, cylindrical lenses located adjacent to the entrance slit, and mirrored convex horns in order to direct additional photons through the entrance slit.

40. The optical analyzer of claim 37, wherein the fluid sample is urine.

65. The optical analyzer of claim 30, further comprising a thermal control to maintain the temperature of each fluid sample.

66. The optical analyzer of claim 38 wherein the plurality of LED modules is at least 5 LED modules.

41. A system for conducting the identification and quantification of micro-organisms in fluid samples, comprising:

a plurality of disposable cartridges for holding a plurality of disposable components including a centrifuge tube, a removable pipette tip;

a tube for an unprocessed fluid sample; and

an optical sample cup or cuvette;

a sample processor for receiving the plurality of disposable cartridges and configured to prepare the fluid samples and to transfer the fluid samples into the respective optical sample cup or cuvette of each of the disposable cartridges; and

an optical analyzer for receiving the plurality of the disposable cartridges and for analyzing the type and quantity of micro-organisms contained in the fluid samples.

42. The system of claim 41, further comprising a second pipette tip.

43. The system of claim 41, wherein the pipette tip has a volume of 1.0 ml.

44. The system of claim 42, wherein the second pipette tip has a volume of 0.5 ml.

45. The system of claim 41, wherein the fluid sample is urine.

47. The system of claim 41, wherein the disposable cartridge further comprises a cassette body.

48. The system of claim 47, wherein the cassette body is bar coded.

49. The system of claim 41, wherein the optical cup or cuvette comprises a container having a tapered end into which a light source travels for the optical analysis of the fluid sample and a reflective surface for enhancing the optical analysis.

50. The system of claim 49, wherein the light source is ultra violet (UV) light.

51. The system of claim 49, wherein the container is made of a material selected from the group consisting of plastic, glass and aluminum and wherein the reflective surface is selected from the group consisting of a coating or a layer of material.

52. The system of claim 49, wherein the reflective surface is an inner reflective surface of the container.

53. The system of claim 49, wherein the container is made of a disposable material.

54. The system of claim 49, wherein the fluid sample is urine.

55. A method for identifying the type and quantity of micro-organisms in a fluid sample, the steps comprising:

a) obtaining a fluid sample;

b) passing the fluid sample through a filter;

c) obtaining a sample of the filtered fluid and placing it into a centrifuge tube;

d) obtaining a dilution of the dissolved material in the urine sample while retaining bacteria in the urine sample by performing the following steps;

1) centrifuging the sample of step c);

2) decanting a portion of the fluid in the centrifuge tube of step

     1);

3) replacing the decanted solution of step

     2) with a saline solution; and

e) transferring the final solution of step

     4) into an optical cups or cuvette; and

f) subjecting the optical cup or cuvette to an optical analysis having optics which include exciting the fluid sample with a plurality of different wavelengths, collecting and detecting the fluorescent emissions; and

directing the fluorescent emissions into a spectrometer.

56. The method of claim 55, wherein step d) results in about a 1,000,000:

1 dilution.

57. The method of claim 55, wherein the sample of step (d)(1) is centrifuged at about 12,000 g-forces.

58. The method of claim 55, wherein about 95% of the fluid from step (d)(2) is decanted.

62. The method of claim 55, wherein after step d(3), further comprising a step of repeating steps (1), (2) and (3) and then transferring the final solution into an optical cup or cuvette for analysis.

63. The method of claim 55, wherein after step (d)(3), further comprising a step of repeating steps (1), (2) and (3) for a plurality of times and then transferring the final solution into an optical cup or cuvette for analysis.

64. The method of claim 63, wherein the plurality of times is at least five times.