Systems and methods for multi-analysis

• US 10,557,863 B2
• Filed: 07/01/2015
• Issued: 02/11/2020
• 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., Chen, Michael, Frankovich, John K., Anekal, Samartha, Lath, Adrit, Loo, Alexander, Pangarkar, Chinmay, Roy, Joy, Smith, Timothy, Young, Daniel
• Primary Examiner(s): Hixson, Christopher Adam
• Application Number:
  US14/789,930
• Publication Number:
  US 20150368717A1
• Time in Patent Office: 1,686 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 biological sample processing system comprising:

an insertable and removable cartridge comprising;

at least one receptacle for receiving a blood sample obtained by a fingerstick from a subject,

at least one assay unit for performing a nucleic acid amplification assay to detect a nucleic acid from the blood sample,

at least a second assay unit for performing another assay on a portion of the blood sample, wherein said another assay does not involve nucleic acid amplification; and

all reagents for performing the nucleic acid amplification assay and said another assay;

and a biological sample processing device comprising;

a housing containing the following;

a cartridge receiving location,

a nucleic acid assay assembly comprising at least one light source, a thermal device comprising a temperature control for the nucleic acid amplification assay, and at least one detector for detecting the nucleic acid;

at least a second detector for use in performing said another assay;

a sample handling system for transporting the blood sample to the at least one assay unit and the at least one assay unit to the detector; and

an airflow unit configured to provide a controlled air-flow environment within said housing;

wherein the at least one light source is mounted on a movable portion of the nucleic acid assay assembly that is movable to cover or uncover a portion of the thermal device.

2. The system of claim 1, further comprising a centrifuge.

3. The system of claim 1, wherein the thermal device provides thermocycling for the nucleic acid amplification.

4. The system of claim 1, wherein the nucleic acid amplification is isothermal amplification.

5. The system of claim 1, wherein the nucleic acid is a nucleic acid from a virus.

6. The system of claim 5, wherein the virus is selected from measles, mumps, rubella, poliomyelitis, hepatitis A, hepatitis B, hepatitis C, hepatitis delta, hepatitis E, influenza, adenovirus, rabies, yellow fever, Epstein-Barr virus, papillomavirus, Ebola virus, Japanese encephalitis, dengue virus, hantavirus, Sendai virus, respiratory syncytial virus, othromyxovirus, vesicular stomatitis virus, visna virus, cytometalovirus, human immunodeficiency virus, and herpes simplex virus.

7. A biological sample processing device comprising:

an insertable and removable cartridge comprising;

a blood sample obtained by a fingerstick from a subject, at least one assay unit for performing a nucleic acid amplification assay to detect a nucleic acid from the blood sample,

at least a second assay unit for performing another assay on a portion of the blood sample, wherein said another assay does not involve nucleic acid amplification, and

all reagents for performing the nucleic acid amplification assay and said another assay;

a housing containing the following;

a nucleic acid assay assembly comprising at least one light source, a thermal device comprising a temperature control for the nucleic acid amplification assay, and at least one detector for detecting the nucleic acid;

at least a second detector for use in performing said another assay;

a sample handling system for transporting (i) the blood sample to the at least one assay unit and the second assay unit;

(ii) the at least one assay unit to the detector for detecting the nucleic acid; and

(iii) the second assay unit to the second detector; and

an airflow unit configured to provide a controlled air-flow environment within said housing;

wherein the at least one light source is mounted on a movable portion of the nucleic acid assay assembly that is movable to cover or uncover a portion of the thermal device.

8. The device of claim 7, further comprising a centrifuge.

9. The device of claim 7, wherein the thermal device provides thermocycling for the nucleic acid amplification.

10. The device of claim 7, wherein the nucleic acid is a nucleic acid from a virus.

11. A biological sample processing device comprising:

an insertable and removable cartridge comprising;

a blood sample obtained by a fingerstick from a subject, at least one assay unit for performing a nucleic acid amplification assay to detect a nucleic acid from the blood sample,

at least a second assay unit for performing another assay on a portion of the blood sample, wherein said another assay does not involve nucleic acid amplification, and

all reagents for performing the nucleic acid amplification assay and said another assay;

a housing containing the following;

a nucleic acid assay assembly comprising at least one light source, a thermal device comprising a temperature control for the nucleic acid amplification assay, and at least one detector for detecting the nucleic acid;

at least a second detector for use in performing said another assay;

a sample handling system for transporting (i) the blood sample to the at least one assay unit and the second assay unit;

(ii) the at least one assay unit to the detector for detecting the nucleic acid; and

(iii) the second assay unit to the second detector; and

an airflow unit configured to provide a controlled air-flow environment within said housing;

wherein the at least one light source is mounted on a movable portion of the nucleic acid assay assembly that is movable to cover or uncover a portion of the thermal device;

wherein the thermal device and at least one detector for detecting the nucleic acid are combined in a single assembly with at least one light source located in the movable portion of the nucleic acid assay assembly positionable so that the light source is in-line with a well of the thermal device holding the at least one assay unit.