ANALYZER SYSTEM

• US 20070166195A1
• Filed: 12/22/2006
• Published: 07/19/2007
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Honeywell International Inc.
• Original Assignee: Honeywell International Inc.
• Inventors: Rezachek, Tom, Padmanabhan, Aravind, Fritz, Bernard, Cabuz, Cleopatra, Reutiman, Peter, Bardell, Ron, Cox, James
• Granted Patent: US 8,383,043 B2
• Time in Patent Office: Days
• US Class Current: 422/68.100
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0636 Focussing flows, e.g. to laminate flows
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2200/146 Employing pressure sensors
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/14 Means for pressure control
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• 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 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• 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 9/527 : for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 15/1404 : Handling flow, e.g. hydrodynamic focusing
• CPC Class Codes: G01N 15/1459 : the analysis being performed on a sample stream
• CPC Class Codes: G01N 15/1484 : microstructural devices
• CPC Class Codes: G01N 2015/011 : with lysing, e.g. of erythrocytes
• CPC Class Codes: G01N 2015/012 : Red blood cells
• CPC Class Codes: G01N 2015/016 : White blood cells
• CPC Class Codes: G01N 2015/018 : Platelets
• CPC Class Codes: G01N 2015/1452 : Adjustment of focus; Alignment
• CPC Class Codes: G01N 2015/1486 : Counting the particles
• CPC Class Codes: G01N 2035/00148 : Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 2035/00158 : Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 2035/00247 : Microvalves
• CPC Class Codes: G01N 2035/1034 : Transferring microquantities of liquid
• CPC Class Codes: G01N 2035/1053 : for separating part of the liquid, e.g. filters, extraction phase
• CPC Class Codes: G01N 21/53 : within a flowing fluid, e.g. smoke
• CPC Class Codes: G01N 2291/02433 : Gases in liquids, e.g. bubbles, foams
• CPC Class Codes: G01N 2291/02836 : Flow rate, liquid level
• CPC Class Codes: G01N 2291/02872 : Pressure
• CPC Class Codes: G01N 29/032 : by measuring attenuation of acoustic waves
• CPC Class Codes: G01N 33/5094 : for blood cell populations red blood cells G01N33/80
• CPC Class Codes: G01N 35/00603 : Reinspection of samples
• CPC Class Codes: G01N 35/00663 : of consumables

Abstract

A system relating to sample analyzers, and more particular, to sample analyzers that are simple to operate and have a reduce risk of providing an erroneous result to a user. In some cases, the sample analyzer may be a portable sample analyzer that includes a disposable fluidic cartridge. The operators of the analyzers need not be trained.

Claims

1. A blood analyzer for performing a blood analysis on a blood sample, comprising:

a removable cartridge, the removable cartridge adapted to receive a blood sample from a user;

an instrument adapted to receive the removable cartridge, the instrument having a user interface;

the instrument and/or cartridge having one or more on-board reagents, the one or more on-board reagents collectively being sufficient to support the desired blood analysis of the blood sample; and

the instrument and cartridge together adapted to perform the desired blood analysis of the blood sample without requiring any user intervention, except for interacting with the user interface of the instrument, once the removable cartridge receives the blood sample and the removable cartridge is received by the instrument and the analysis is started.

2. The blood analyzer of claim 1 further comprising a quick reference instruction guide, wherein the quick reference instruction guide is secured relative to the instrument.

3. The blood analyzer of claim 1, further comprising:

a pocket attached to or in the instrument;

a quick reference instruction guide adapted to be inserted into the pocket.

4. The blood analyzer of claim 1 further comprising a quick reference instruction guide, wherein the quick reference instruction guide is secured relative to the cartridge.

5. The blood analyzer of claim 1, wherein the blood analyzer is constructed such that the user does not need any technical or specialized training with respect to troubleshooting or interpretation of any error codes.

6. The blood analyzer of claim 1, wherein the blood analyzer is constructed such that the blood analyzer does not require any preventative maintenance for a period of greater than one month.

7. The blood analyzer of claim 1, wherein the blood analyzer is constructed such that the blood analyzer does not require any preventative maintenance for a period greater than six months.

8. The blood analyzer of claim 1, wherein the blood analyzer produces a result that does not require the user to perform any calibration, interpretation, or calculation based on the result.

9. The blood analyzer of claim 1, wherein the blood analyzer produces a binary result.

10. The blood analyzer of claim 1, wherein the blood analyzer produces a result that is a numerical value.

11. The blood analyzer of claim 1, wherein the blood analyzer produces a result that indicates an acceptable or unacceptable result.

12. The blood analyzer of claim 1, wherein the blood analyzer indicates an acceptable or unacceptable hematology result and/or an acceptable or unacceptable immunoassay result.

13. The blood analyzer of claim 1, wherein the blood analyzer provides a complete blood count.

14. The blood analyzer of claim 1, wherein the blood analyzer provides a CD4, CD45, CDX and/or CDXX indication.

15. The blood analyzer of claim 1, wherein the blood analyzer produces a result that includes a color gradation on a display or on a printed paper.

16. The blood analyzer of claim 1, wherein the blood analyzer provides a result, and further provides instructions for obtaining and shipping a blood sample for confirmation testing in cases where the result falls within a range that indicates such testing is clinically advisable.

17. The blood analyzer of claim 1, wherein the blood analyzer includes one or more fail-safe mechanisms to help prevent erroneous results from being reported to the user.

18. The blood analyzer of claim 17, wherein the one or more fail-safe mechanisms include a lock-out mechanism that helps ensure that the blood analyzer does not provide a result when one or more test conditions are inappropriate.

19. The blood analyzer of claim 17, wherein the one or more fail-safe mechanisms include a lock-out mechanism that helps ensure that the blood analyzer does not provide a result when a faulty test condition is detected in the blood analyzer.

20. The blood analyzer of claim 18, wherein the lock-out mechanism prevents the blood analyzer from providing a result if the result is outside a predetermined range

21. The blood analyzer of claim 18, wherein the lock-out mechanism prevents the blood analyzer from providing a result if a component of the blood analyzer malfunctions.

22. The blood analyzer of claim 18, wherein the lock-out mechanism prevents the blood analyzer from providing a result if there is a detected user error.

23. The blood analyzer of claim 1, wherein the blood analyzer includes one or more failure alert mechanisms to alert the user of erroneous results being reported by the blood analyzer.

24. The blood analyzer of claim 23, wherein the one or more failure alert mechanisms alert the user of a malfunction in the blood analyzer.

25. The blood analyzer of claim 24, wherein at least one of the one or more failure alert mechanisms allow the user to correct a malfunction, and then to proceed.

26. The blood analyzer of claim 24, wherein at least one of the one or more failure alert mechanisms alert the user that the result is unreliable due to a detected malfunction in the blood analyzer.

27. The blood analyzer of claim 24, wherein at least one of the one or more failure alert mechanisms are selected from the group consisting of:

one or more external controls, one or more internal procedural controls, and one or more checks to assure proper functioning of the blood analyzer.

28. The blood analyzer of claim 1, further comprising a detection mechanism for detecting if the blood sample is present in the removable cartridge.

29. The blood analyzer of claim 1, further comprising a detection mechanism for detecting if the sample that is provided to the removable cartridge is not a blood sample.

30. The blood analyzer of claim 1, further comprising a detection mechanism for detecting if the blood sample is coagulated.

31. The blood analyzer of claim 1, wherein the instrument includes one or more reagent reservoirs for storing a number of reagents, the blood analyzer providing one or more of the reagents to the removable cartridge during analysis.

32. The blood analyzer of claim 31, wherein the blood analyzer further includes a detection mechanism for detecting if the one or more reagents stored in the number of reagent reservoirs are compatible with the particular removable cartridge that is received by the instrument.

33. The blood analyzer of claim 22, wherein the one or more reagents stored in the number of reagent reservoirs have a shelf life, and wherein the blood analyzer further includes a detection mechanism for detecting if the one or more reagents stored in the number of reagent reservoirs are in compliance with the shelf life.

34. The blood analyzer of claim 31, wherein the one or more reagents stored in the number of reagent reservoirs have storage criteria, and wherein the blood analyzer further includes a detection mechanism for detecting if the one or more reagents have been stored in compliance with one or more of the storage criteria.

35. The blood analyzer of claim 1, further comprising:

a hematology analyzer portion; and

an immunoassay portion.

36. The blood analyzer of claim 35, wherein:

the hematology analyzer portion provides at least a complete blood count; and

the immunoassay portion provides HIV/AIDS information.

37. The blood analyzer of claim 35, wherein:

the hematology analyzer portion indicates to an unskilled user whether its results are acceptable or not; and

the immunoassay portion indicates to an unskilled user whether its results are acceptable or not.

38. The blood analyzer of claim 1, wherein the blood analyzer includes electronics, and wherein the blood analyzer includes built in self test (BIST) to perform self test on at least part of the electronics.

39. The blood analyzer of claim 38, wherein the built in self test (BIST) tests the at least part of the electronics to an expected mean time between failure (MTBF) rate of greater than 8000 hours.

40. The blood analyzer of claim 39, wherein the built in self test (BIST) tests the at least part of the electronics to an expected mean time between failure (MTBF) rate of greater than 50,000 hours.

41. The blood analyzer of claim 39, wherein the built in self test (BIST) tests the at least part of the electronics to an expected mean time between failure (MTBF) rate of greater than 100,000 hours.

42. The blood analyzer of claim 38, wherein the built in self test (BIST) checks that the at least part of the electronics are within a predefined specification.

43. The blood analyzer of claim 1, further comprising:

a calibration cartridge that is adapted to be received by the instrument; and

wherein the calibration cartridge is used to calibrate at least part of the blood analyzer.

44. The blood analyzer of claim 1, further comprising:

a calibration cartridge that is adapted to be received by the instrument; and

wherein;

the calibration cartridge is used to calibrate at least part of the blood analyzer;

the calibration cartridge has a standard control sample for a hematology part of the blood analyzer; and

/or

the calibration cartridge has a standard control sample for an immunoassay part of the blood analyzer.

45. The blood analyzer of claim 44, wherein the blood analyzer communicates to the user when to insert the calibration cartridge.

46. The blood analyzer of claim 45, wherein the blood analyzer communicates to the user at predefined intervals when to insert the calibration cartridge.

47. The blood analyzer of claim 1, wherein the blood analyzer is a flow cytometer, and the blood sample is a whole blood sample.

48. A blood analyzer for performing a blood analysis on a blood sample, comprising:

a single use removable cartridge, the single use removable cartridge adapted to receive a blood sample from a user;

an instrument adapted to receive the single use removable cartridge;

the instrument and/or cartridge having one or more on-board reagents, the one or more on-board reagents collectively being sufficient to support the desired blood analysis of the blood sample; and

the instrument and cartridge together adapted to perform the desired blood analysis of the blood sample without requiring any user intervention once the single use removable cartridge receives the blood sample and the single use removable cartridge is received by the instrument and the analysis is started.

49. A blood analyzer for performing a blood analysis on a blood sample, comprising:

a single use removable cartridge, the single use removable cartridge adapted to receive a blood sample from a user;

an instrument adapted to receive the single use removable cartridge, the instrument having a user interface;

the instrument and/or cartridge having one or more on-board reagents, the one or more on-board reagents collectively being sufficient to support the desired blood analysis of the blood sample; and

the instrument and cartridge together adapted to perform the desired blood analysis of the blood sample without requiring any user intervention, except for interacting with the user interface of the instrument, once the single use removable cartridge receives the blood sample and the single use removable cartridge is received by the instrument and the analysis is started.

50. A blood analyzer for performing a blood analysis on a blood sample, comprising:

a single use removable cartridge, the single use removable cartridge adapted to receive a blood sample from a user;

an instrument adapted to receive the single use removable cartridge;

the instrument and/or cartridge having one or more on-board reagents, the one or more on-board reagents collectively being sufficient to support the desired blood analysis of the blood sample; and

the instrument and cartridge together adapted to perform the desired blood analysis of the blood sample without requiring any sample manipulation by the user once the single use removable cartridge receives the blood sample and the single use removable cartridge is received by the instrument.