Systems and methods for multi-analysis

• US 10,018,643 B2
• Filed: 09/09/2015
• Issued: 07/10/2018
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos IP Company, LLC
• Inventors: Holmes, Elizabeth A., Pangarkar, Chinmay, Anekal, Samartha, Frankovich, John K., Chen, Michael, Smith, Timothy
• Primary Examiner(s): Ghafoorian, Reza
• Application Number:
  US14/848,775
• Publication Number:
  US 20160011225A1
• Time in Patent Office: 1,035 Days
• CPC Class Codes: B01L 2300/1827 using resistive heater
• CPC Class Codes: B01L 2300/1855 using phase changes in a medium
• CPC Class Codes: B01L 3/021 Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
• 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 3/5082 Test tubes per se
• CPC Class Codes: B01L 3/50855 using modular assemblies of strips or of individual wells
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: B01L 9/543 for disposable pipette tips, e.g. racks or cassettes
• CPC Class Codes: C12Q 1/42 involving phosphatase
• CPC Class Codes: C12Q 1/52 involving transaminase
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/70 involving virus or bacteriophage immunoassay for viruses G01N33/56983
• CPC Class Codes: G01N 15/1433 using image recognition
• CPC Class Codes: G01N 2015/012 Red blood cells
• CPC Class Codes: G01N 2015/016 White blood cells
• CPC Class Codes: G01N 2015/1006 for cytology
• CPC Class Codes: G01N 2015/1486 Counting the particles
• CPC Class Codes: G01N 2035/00138 Slides
• CPC Class Codes: G01N 2035/00148 : Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 2035/00237 : Handling microquantities of analyte, e.g. microvalves, capillary networks
• CPC Class Codes: G01N 2035/00306 : Housings, cabinets, control panels (details)
• CPC Class Codes: G01N 2035/00326 : Analysers with modular structure
• CPC Class Codes: G01N 2035/00356 : Holding samples at elevated temperature (incubation)
• CPC Class Codes: G01N 2035/00366 : Several different temperatures used
• CPC Class Codes: G01N 2035/00425 : Heating or cooling means associated with pipettes or the like, e.g. for supplying sample/reagent at given temperature
• CPC Class Codes: G01N 2035/00435 : Refrigerated reagent storage
• CPC Class Codes: G01N 2035/00495 : Centrifuges
• CPC Class Codes: G01N 2035/00633 : logging process history of individual samples
• CPC Class Codes: G01N 2035/0449 : using centrifugal transport of liquid
• CPC Class Codes: G01N 2035/0474 : Details of actuating means for conveyors or pipettes
• CPC Class Codes: G01N 2035/0486 : Gearing, cams
• CPC Class Codes: G01N 2035/0491 : Position sensing, encoding; closed-loop control
• CPC Class Codes: G01N 2035/0493 : Locating samples; identifying different tube sizes
• CPC Class Codes: G01N 2035/0494 : Detecting or compensating piositioning errors
• CPC Class Codes: G01N 21/25 : Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
• CPC Class Codes: G01N 21/27 : using photo-electric detection G01N21/31 takes precedence; circuits for computing concentration logarithmic circuits G06G7/24; photometric circuits in general G01J
• CPC Class Codes: G01N 2201/024 : Modular construction
• CPC Class Codes: G01N 2201/04 : Batch operation; multisample devices
• CPC Class Codes: G01N 2201/12 : Circuits of general importance; Signal processing
• CPC Class Codes: G01N 33/5005 : involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025
• CPC Class Codes: G01N 33/54306 : Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54313 : the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/56972 : White blood cells
• CPC Class Codes: G01N 33/56983 : Viruses
• CPC Class Codes: G01N 33/62 : involving urea
• CPC Class Codes: G01N 33/6827 : Total protein determination, e.g. albumin in urine
• CPC Class Codes: G01N 33/80 : involving blood groups or blood types or red blood cells white blood cells G01N33/56972
• CPC Class Codes: G01N 33/92 : involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: G01N 35/00 : Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
• CPC Class Codes: G01N 35/00029 : provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00069 : whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk
• CPC Class Codes: G01N 35/00623 : of instruments
• CPC Class Codes: G01N 35/00871 : Communications between instruments or with remote terminals
• CPC Class Codes: G01N 35/0092 : Scheduling
• CPC Class Codes: G01N 35/026 : having blocks or racks of reaction cells or cuvettes
• CPC Class Codes: G01N 35/04 : Details of the conveyor system G01N35/021 - G01N35/028 take precedence
• CPC Class Codes: G01N 35/10 : Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices G01N35/0099 takes precedence
• CPC Class Codes: G01N 35/1009 : Characterised by arrangements for controlling the aspiration or dispense of liquids
• CPC Class Codes: G01N 35/1011 : Control of the position or alignment of the transfer device
• CPC Class Codes: G01N 35/1065 : Multiple transfer devices
• CPC Class Codes: G01N 35/1072 : with provision for selective pipetting of individual channels
• CPC Class Codes: Y10T 436/111666 : Utilizing a centrifuge or compartmented rotor
• CPC Class Codes: Y10T 436/113332 : with conveyance of sample along a test line in a container or rack

Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims

1. A point of care biological sample processing system for performing assays with two or more different types of biological samples obtained from at least one subject comprising:

an insertable and removable cartridge comprising (i) a first location for receiving a first biological sample obtained from the at least one subject;

(ii) a second location for receiving a second biological sample obtained from the at least one subject, wherein the first biological sample is a blood sample and the second biological sample is a non-blood sample;

(iii) a first cuvette for performing a first assay on the first biological sample to detect a first analyte, wherein the first assay comprises a thermocycling nucleic acid amplification assay;

(iv) a second cuvette for performing a second assay on the second biological sample to detect a second analyte, wherein the second assay is a culture assay for detecting a microorganism; and

(v) all reagents for performing the first and second assays, the cartridge has a multi-layer design wherein at least some cartridge assay components are located below one of said first cuvette or said second cuvette and are accessible only after the first cuvette or second cuvette is detached from the cartridge;

and

a sample processing device comprising a cartridge receiving location for receiving the insertable and removable cartridge, a thermocycler for performing the nucleic acid amplification assay, a cytometer, and at least one automated sample handling device comprising a first pipette head and a second pipette head, wherein the first pipette head and the second pipette head are mounted on a common support structure and are independently movable and independently controllable in relation to the other.

2. The system of claim 1, wherein the at least one automated sample handling device is configured to transfer (i) the first biological sample to the first cuvette;

(ii) the second biological sample to the second cuvette; and

(iii) the first cuvette to the thermocycler and the second cuvette to the cytometer.

3. The system of claim 1, wherein the sample processing device comprises (i) a first automated sample handling device comprising the first pipette head and the second pipette head, wherein the first pipette head and the second pipette head are mounted on a first common support structure and are independently moveable and independently controllable in relation to the other, and wherein the first automated handling device is configured to transfer at least a portion of the first biological sample to the first cuvette and the first cuvette to the thermocycler;

and (ii) a second automated sample handling device comprising a third pipette head and a fourth pipette head, wherein the third pipette head and the fourth pipette head are mounted on a second common support structure and are independently movable and independently controllable in relation to the other, and wherein the second automated sample handling device is configured to transfer at least a portion of the second biological sample to the second cuvette and the second cuvette to the cytometer.

4. The system of claim 1, wherein the system comprises a first sample vessel for collecting the first biological sample and a second sample vessel for collecting the second biological sample, and the first and second sample vessels are different.

5. The system of claim 1, wherein the first and second cuvettes are each fluidically isolated and movable.

6. The system of claim 1, wherein the second biological sample is obtained on a swab.

7. A method for performing assays with two or more different types of biological samples obtained from at least one subject, comprising:

receiving in the sample processing device of the system of claim 1 the insertable and removable cartridge;

wherein the cartridge comprises the first and second biological samples and the sample processing device performs the first and second assays and detects the first and second analytes.

17. The system of claim 1, wherein the at least one automated sample handling device comprises at least two different mechanisms for dispensing and/or aspirating a fluid.

18. The system of claim 17, wherein the two different mechanisms for dispensing and/or aspirating a fluid is selected from the group positive displacement, air displacement, and suction.

19. The system of claim 1, wherein the first pipette head is a positive displacement pipette head and the second pipette head is an air displacement pipette head.

20. The method of claim 7, wherein the at least one automated sample handling device comprises at least two different mechanisms for dispensing and/or aspirating a fluid.

21. The method of claim 20, wherein the two different mechanisms for dispensing and/or aspirating a fluid is selected from the group positive displacement, air displacement, and suction.

22. The method of claim 7, wherein the first pipette head is a positive displacement pipette head and the second pipette head is an air displacement pipette head.

8. A point of care biological sample processing system for performing assays with two or more different types of biological samples obtained from at least one subject comprising:

a first insertable and removable cartridge comprising (i) a first location for receiving a first biological sample obtained from the at least one subject, wherein the first biological sample is a blood sample;

(ii) a first cuvette for performing a first assay on the first biological sample to detect a first analyte, wherein the first assay comprises a thermocycling nucleic acid amplification assay; and

(iii) all reagents for performing the first assay;

a second insertable and removable cartridge comprising (iv) a second location for receiving a second biological sample obtained from the at least one subject, wherein the second biological sample is a non-blood sample;

(v) a second cuvette for performing a second assay on the second biological sample to detect a second analyte, wherein the second assay is a culture assay for detecting a microorganism; and

(vi) all reagents for performing the second assay; and

a sample processing device comprising (a) at least one cartridge receiving location for receiving at least one insertable and removable cartridge, (b) a thermocycler for performing the nucleic acid amplification assay, (c) a cytometer, and (d) at least one automated sample handling device comprising a first pipette head and a second pipette head, wherein the first pipette head and the second pipette head are mounted on a common support structure and are independently movable and independently controllable.

9. The system of claim 8, wherein the at least one automated sample handling device is configured to transfer (i) the first biological sample to the first cuvette;

(ii) the second biological sample to the second cuvette; and

(iii) the first cuvette to the thermocycler and the second cuvette to the cytometer.

10. The system of claim 8, wherein the sample processing device comprises (i) a first automated sample handling device comprising the first pipette head and the second pipette head, wherein the first pipette head and the second pipette head are mounted on a first common support structure and are independently movable and independently controllable, and wherein the first automated sample handling device is configured to transfer the first biological sample to the first cuvette and the first cuvette to the thermocycler;

and (ii) a second automated sample handling device comprising a third pipette head and a fourth pipette head, wherein the third pipette head and the fourth pipette head are mounted on a second common support structure and are independently movable and independently controllable, and wherein the second automated sample handling device is configured to transfer the second biological sample to the second cuvette and the second cuvette to the cytometer.

11. The system of claim 8, wherein the sample processing device comprises one cartridge receiving location for receiving the first and second insertable and removable cartridges.

12. The system of claim 8, wherein the sample processing device comprises a first and second module, wherein the first module comprises a first cartridge receiving location for receiving the first insertable and removable cartridge, and the second module comprises a second cartridge location for receiving the second insertable and removable cartridge.

13. The system of claim 12, wherein the first module comprises the thermocycler and the second module comprises the cytometer.

14. The system of claim 8, wherein the first and second cuvettes are each fluidically isolated and movable.

15. The system of claim 8, wherein the second biological sample is obtained on a swab.

16. A method of performing assays with two or more different types of biological samples obtained from at least one subject, comprising:

receiving in the sample processing device of the system of claim 8 the first and second cartridges;

wherein the first cartridge comprises the first sample and the second cartridge comprises the second sample, and the sample processing device performs the first and second assays and detects the first and second analytes.

23. The system of claim 8, wherein the at least one automated sample handling device comprises at least two different mechanisms for dispensing and/or aspirating a fluid.

24. The system of claim 23, wherein the two different mechanisms for dispensing and/or aspirating a fluid is selected from the group positive displacement, air displacement, and suction.

25. The system of claim 8, wherein the first pipette head is a positive displacement pipette head and the second pipette head is an air displacement pipette head.

26. The method of claim 16, wherein the at least one automated sample handling device comprises at least two different mechanisms for dispensing and/or aspirating a fluid.

27. The method of claim 26, wherein the two different mechanisms for dispensing and/or aspirating a fluid is selected from the group positive displacement, air displacement, and suction.

28. The method of claim 16, wherein the first pipette head is a positive displacement pipette head and the second pipette head is an air displacement pipette head.